Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial)

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01626079
• Collaborator: (none)
• Enrollment: 614
• Locations: 86
• Arms: 2
• Anticipated Duration (Months): 143
• Patients Per Site: 7.1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in Symptomatic Heart Failure Subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. This randomized controlled trial will provide the opportunity to strengthen or add labeling claims regarding safety and clinical benefits of the MitraClip System for symptomatic heart failure patients with moderate-to-severe or severe functional mitral regurgitation.

Approximately 610 subjects will be randomized at up to 100 investigational sites with approximately 305 subjects targeted to receive the study device. COAPT study completed recruiting subjects in June 2017.

As part of the COAPT trial, a subset of patients will be registered in the cardiopulmonary exercise (CPX) sub-study. The objective of this sub-study is to evaluate the exercise responses in a sub-cohort of COAPT subjects who receive MitraClip device (Device group) compared to the Control group who do not receive MitraClip device. (Note: the CPX Sub-study subjects will contribute to the analyses of the COAPT primary and secondary endpoints)

As an extension of the COAPT RCT trial, COAPT CAS study will be conducted after COAPT enrollment is complete under the same investigational device exemption (IDE(G120024)). The objective of this study is to evaluate the MitraClip® NT System for the treatment of clinically significant functional mitral regurgitation (FMR) in symptomatic heart failure subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. The anticipated Study Completion Date is July 2024. COAPT CAS completed recruiting subjects in March 2019.

Condition or Disease	Intervention/Treatment	Phase
Mitral Regurgitation; Mitral Valve Regurgitation; Treatment of Functional Mitral Regurgitation in Symptomatic Heart Failure Subjects; Heart Failure	Device: MitraClip System	N/A

Detailed Description

Prospective, randomized, parallel-controlled, multicenter clinical evaluation of the MitraClip device for the treatment of clinically significant functional mitral regurgitation in symptomatic heart failure subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. Eligible subjects will be randomized in a 1:1 ratio to the MitraClip device (Device group) or to no MitraClip device (Control group).

As part of the COAPT trial, a subset of patients (at least 50 up to 100 in total) will be registered in the CPX Sub-study, which is designed as a prospective, randomized (1:1 ratio to the MitraClip or no MitraClip device), parallel-controlled, multicenter study registering approximately 50-100 subjects in up to 50 qualified US sites from the COAPT trial. Subjects registered and randomized in the CPX Sub-study will contribute to the total enrollment approximately of 610 subjects in the COAPT trial. Roll-in subjects will not participate in the CPX Sub-study.

The COAPT CAS study is designed as a prospective, multicenter, single arm, continued access registry study. A maximum of 800 subjects (anticipated) will be registered from up to 75 sites in the United States. The enrollment will end once pre-market approval (PMA) of the proposed expanded indication of MitraClip System is obtained. Active follow-up of patients will be performed through 12 months with scheduled visits at 30 days and 12 months. The national Trans catheter Valve Therapy Registry (TVT Registry) will be used for data collection through 12 months. Annual follow-up data from 2 years through year 5 post-implant will be obtained by linkage to the Centers for Medicare and Medicaid Services (CMS) Claims database.

COAPT CAS data may be used to support the PMA application of the labeling claims for the treatment of moderate to severe or severe FMR in symptomatic heart failure subjects. This single arm registry will provide valuable new information regarding use of the MitraClip® NT System under more "real world" conditions.

COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019.

Study Design

• Study Type: Interventional
• Actual Enrollment: 614 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Clinical Evaluation of the Safety and Effectiveness of the MitraClip® System for the Treatment of Functional Mitral Regurgitation in Symptomatic Heart Failure Subjects (COAPT Recruitment Closed). COAPT CAS (Recruitment Closed)
• Actual Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Mar 1, 2019
• Anticipated Study Completion Date: Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MitraClip System Percutaneous mitral valve repair using MitraClip System	Device: MitraClip System; Percutaneous mitral valve repair using MitraClip System; Other Names: MitraClip device MitraClip
No Intervention: Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.

Outcome Measures

Primary Outcome Measures

1. Primary Safety Endpoint - Percentage of Participants With Freedom From Device Related Complications at 12 Months [12 months]

   Percentage of Participants with Freedom from Device related Complications at 12 Months. Composite of Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, and any device related complications requiring non-elective cardiovascular surgery.

2. Primary Effectiveness Endpoint [24 months]

   Recurrent HF hospitalizations (HFH) through 24 months, analyzed when the last subject completes 12-month follow-up

Secondary Outcome Measures

1. Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis) [12 months]

   Number of recurrent Heart Failure hospitalization events at 12 months.

2. New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis) [12 months]

   The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms Class IV - Severe limitations.

3. New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis) [30 days]

   The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms Class IV - Severe limitations.

4. Quality of Life (QOL) (COAPT CAS Study Analysis) Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) [12 months]

   COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019. Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.

5. Quality of Life (QOL) (COAPT CAS Study Analysis) Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) [30 days]

   The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

6. Six Minute Walk Test (6MWT Distance or 6MWD) (COAPT CAS Study Analysis) [12 months]

   COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019. Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.

7. Six Minute Walk Test (6MWT Distance or 6MWD) (COAPT CAS Study Analysis) [30 days]

   The Six Minute Walk Test (6MWT) is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.

8. Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis) [12 months]

   COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019. Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.

9. Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis) [30 days]

   MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2

10. Major and/or Life Threatening Bleeding (COAPT CAS Study Analysis) [12 months]

    COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019. Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.

11. Major and/or Life Threatening Bleeding (COAPT CAS Study Analysis) [30 days]

12. Major Vascular Complications (COAPT CAS Study Analysis) [12 months]

    COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019. Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.

13. Major Vascular Complications (COAPT CAS Study Analysis) [30 days]

14. Renal Complication With Requirement for Dialysis (COAPT CAS Study Analysis) [12 months]

    COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019. Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.

15. Renal Complication With Requirement for Dialysis (COAPT CAS Study Analysis) [30 days]

16. Transient Ischemic Attack (TIA) (COAPT CAS Study Analysis) [12 months]

    COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019. Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.

17. Transient Ischemic Attack (TIA) (COAPT CAS Study Analysis) [30 days]

18. Stroke (COAPT CAS Study Analysis) [12 months]

    COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019. Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.

19. Stroke (COAPT CAS Study Analysis) [30 days]

20. Myocardial Infarction (MI) (COAPT CAS Study Analysis) [12 months]

    COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019. Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.

21. Myocardial Infarction (MI) (COAPT CAS Study Analysis) [30 days]

22. Death and Primary Cause of Death (COAPT CAS Study Analysis) [12 months]

    COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019. Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.

23. Death and Primary Cause of Death (COAPT CAS Study Analysis) [30 days]

24. Percentage of Patients Free From the Composite of All-cause Death, Stroke, MI, or Non-elective Cardiovascular Surgery for Device Related Complications in the Device Group [30 days post-procedure in the Device group]

    The percentage of patients free from the composite endpoint as described above.

25. Number of Deaths at 12 Months (All Cause Mortality) [12 months]

    Death from any cause mortality at 12months.

26. Number of Participants With Mitral Regurgitation Severity Grade of 2+ or Lower at 12 Months [12 months]

    MR severity grade of 2+ or lower at 12 months MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2

27. Change in Distance Walked on the 6 Minute Walk Test (6MWT Distance or 6MWD) [12 months over baseline]

    The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.

28. Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) [12 months over baseline]

    Paired data looking at difference between the baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and 12 month KCCQ score. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

29. Change in Left Ventricular End Diastolic Volume (LVEDV) [12 months over baseline]

    Paired data comparing the Change in LVEDV at baseline vs 12 months

30. Number of Participants With New York Heart Association (NYHA) Functional Class I/II [12 months]

    NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA CLASS) Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

31. Recurrent Hospitalizations - All Cause [24 Months]

    Number of Recurrent Hospitalizations for any cause within 24 months.

32. Death or HF Hospitalization Within 24 Months (Finkelstein-Schoenfeld Analysis of All-Cause Death or Recurrent HF Hospitalization Through 24 Months) [24 months]

    The win ratio is a useful method for providing an estimate of the treatment effect when composite endpoints are analyzed as the analysis accounts for clinical significance of the outcomes of interest. For example, in the composite of death and recurrent HF hospitalizations through 24 months, subjects in the Device and Control groups were formed into matched pairs, where each pair of subjects was classified into 1 of 5 outcomes scenarios: A. Death in Device group first B. Death in Control group first C. More HF hospitalizations in the Device group (or in the case of a tie, the first HF hospitalization in the Device group occurs first) D. More HF hospitalization in the Control group (or in the case of tie, the first HF hospitalization in the Control group occurs first) E. None of the above In this way, the number of "Winners" in the Device group was NW = NB + ND while the number of "Losers" in the Device group was NL = NA + NC. The "Win Ratio" was then calculated as NW/NL.

33. Death and Primary Cause of Death (COAPT CAS Study Analysis) [2 years]

    The COAPT study is still on-going. Only the Primary and major secondary endpoints have been entered. Rest of the results will be entered when the study ends in July 2024.

34. Death and Primary Cause of Death (COAPT CAS Study Analysis) [3 years]

35. Death and Primary Cause of Death (COAPT CAS Study Analysis) [4 years]

36. Death and Primary Cause of Death (COAPT CAS Study Analysis) [5 years]

37. Myocardial Infarction (MI) (COAPT CAS Study Analysis) [2 years]

38. Myocardial Infarction (MI) (COAPT CAS Study Analysis) [3 years]

39. Myocardial Infarction (MI) (COAPT CAS Study Analysis) [4 years]

40. Myocardial Infarction (MI) (COAPT CAS Study Analysis) [5 years]

41. Stroke (COAPT CAS Study Analysis) [2 years]

42. Stroke (COAPT CAS Study Analysis) [3 years]

43. Stroke (COAPT CAS Study Analysis) [4 years]

44. Stroke (COAPT CAS Study Analysis) [5 years]

45. Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis) [2 years]

46. Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis) [3 years]

47. Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis) [4 years]

48. Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis) [5 years]

49. Kaplan-Meier Freedom From All-cause Mortality [24 months]

    Death from any cause within 24 months - no of events

Other Outcome Measures

1. Device or Procedure-Related Adverse Events [Within and after 30 days of the procedure]

   Device or procedure-related adverse events are defined as adverse events that are adjudicated by the Clinical Events Committee as possibly, probably or definitely device and/or procedure-related, regardless of the temporal relationship to the MitraClip procedure. Device or procedure-related adverse events will be broken down into those that occur within 30 days of the procedure and those that occur after 30 days of the procedure. Examples of device-related adverse events are: myocardial perforation, Single Leaflet Device Attachment, embolization of the MitraClip device or MitraClip System components, iatrogenic atrial septal defect, mitral valve stenosis, need for mitral valve replacement instead of repair due at least in part to the MitraClip procedure or the presence of the MitraClip device.

2. Implant Rate [Day 0]

   Defined as the rate of successful delivery and deployment of the MitraClip device(s) with echocardiographic evidence of leaflet approximation and retrieval of the delivery catheter

3. Device Procedure Time [Day 0]

   Defined as the time elapsed from the start of the transseptal procedure to the time the Steerable Guide Catheter is removed

4. Total Procedure Time [Day 0]

   Defined as the time elapsed from the first of any of the following: intravascular catheter placement, anesthesia or sedation, or transesophageal echocardiogram (TEE), to the removal of the last catheter and TEE

5. Device Time [Day 0]

   Defined as the time the Steerable Guide Catheter is placed in the intra-atrial septum until the time the MitraClip Delivery System (CDS) is retracted into the Steerable Guide Catheter

6. Fluoroscopy Duration [Day 0]

   Defined as the duration of exposure to fluoroscopy during the MitraClip procedure

7. MR Severity Grade [Baseline]

   MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2

8. MR Severity Grade [At discharge (or 30 days if discharge echocardiogram is not available)]

   MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2

9. MR Severity Grade [6 months]

   MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2

10. MR Severity Grade [12 months]

    MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2

11. MR Severity Grade [24 months]

    MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2

12. MR Severity Grade [3 years]

13. MR Severity Grade [4 years]

14. MR Severity Grade [5 years]

15. Effective Regurgitant Orifice Area [Baseline]

    Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity

16. Effective Regurgitant Orifice Area [At discharge (or 30 days if discharge echocardiogram is not available)]

    Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity

17. Effective Regurgitant Orifice Area [6 months]

    Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity

18. Effective Regurgitant Orifice Area [12 months]

    Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity

19. Effective Regurgitant Orifice Area [24 months]

    Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity

20. Effective Regurgitant Orifice Area [3 years]

21. Effective Regurgitant Orifice Area [4 years]

22. Effective Regurgitant Orifice Area [5 years]

23. Regurgitant Volume [Baseline]

    Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole.

24. Regurgitant Volume [At discharge (or 30 days if discharge echocardiogram is not available)]

    Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole.

25. Regurgitant Volume [6 months]

    Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole.

26. Regurgitant Volume [12 months]

    Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole.

27. Regurgitant Volume [24 months]

    Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole.

28. Regurgitant Volume [3 years]

29. Regurgitant Volume [4 years]

30. Regurgitant Volume [5 years]

31. Regurgitant Fraction [Baseline]

    Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency.

32. Regurgitant Fraction [At discharge (or 30 days if discharge echocardiogram is not available)]

    Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency.

33. Regurgitant Fraction [6 months]

    Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency.

34. Regurgitant Fraction [12 months]

    Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency.

35. Regurgitant Fraction [24 months]

    Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency.

36. Regurgitant Fraction [3 years]

37. Regurgitant Fraction [4 years]

38. Regurgitant Fraction [5 years]

39. Left Ventricle End Diastolic Volume (LVEDV) [Baseline]

    Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.

40. Left Ventricle End Diastolic Volume (LVEDV) [At discharge (or 30 days if discharge echocardiogram is not available)]

    Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.

41. Left Ventricle End Diastolic Volume (LVEDV) [6 months]

    Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.

42. Left Ventricle End Diastolic Volume (LVEDV) [12 months]

    Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.

43. Left Ventricle End Diastolic Volume (LVEDV) [24 months]

    Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.

44. Left Ventricle End Diastolic Volume (LVEDV) [3 years]

45. Left Ventricle End Diastolic Volume (LVEDV) [4 years]

46. Left Ventricle End Diastolic Volume (LVEDV) [5 years]

47. Left Ventricular End Systolic Volume (LVESV) [Baseline]

    Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle.

48. Left Ventricular End Systolic Volume (LVESV) [At discharge (or 30 days if discharge echocardiogram is not available)]

    Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle.

49. Left Ventricular End Systolic Volume (LVESV) [6 months]

    Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle.

50. Left Ventricular End Systolic Volume (LVESV) [12 months]

    Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle.

51. Left Ventricular End Systolic Volume (LVESV) [24 months]

    Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle.

52. Left Ventricular End Systolic Volume (LVESV) [3 years]

53. Left Ventricular End Systolic Volume (LVESV) [4 years]

54. Left Ventricular End Systolic Volume (LVESV) [5 years]

55. Left Ventricular End Diastolic Dimension (LVEDD) [Baseline]

56. Left Ventricular End Diastolic Dimension (LVEDD) [At discharge (or 30 days if discharge echocardiogram is not available)]

57. Left Ventricular End Diastolic Dimension (LVEDD) [6 months]

58. Left Ventricular End Diastolic Dimension (LVEDD) [12 months]

59. Left Ventricular End Diastolic Dimension (LVEDD) [24 months]

60. Left Ventricular End Diastolic Dimension (LVEDD) [3 years]

61. Left Ventricular End Diastolic Dimension (LVEDD) [4 years]

62. Left Ventricular End Diastolic Dimension (LVEDD) [5 years]

63. Left Ventricular End Systolic Dimension (LVESD) [Baseline]

64. Left Ventricular End Systolic Dimension (LVESD) [At discharge (or 30 days if discharge echocardiogram is not available)]

65. Left Ventricular End Systolic Dimension (LVESD) [6 months]

66. Left Ventricular End Systolic Dimension (LVESD) [12 months]

67. Left Ventricular End Systolic Dimension (LVESD) [24 months]

68. Left Ventricular End Systolic Dimension (LVESD) [3 years]

69. Left Ventricular End Systolic Dimension (LVESD) [4 years]

70. Left Ventricular End Systolic Dimension (LVESD) [5 years]

71. Left Ventricular Ejection Fraction (LVEF) [Baseline]

72. Left Ventricular Ejection Fraction (LVEF) [At discharge (or 30 days if discharge echocardiogram is not available)]

73. Left Ventricular Ejection Fraction (LVEF) [6 months]

74. Left Ventricular Ejection Fraction (LVEF) [12 months]

75. Left Ventricular Ejection Fraction (LVEF) [24 months]

76. Left Ventricular Ejection Fraction (LVEF) [3 years]

77. Left Ventricular Ejection Fraction (LVEF) [4 years]

78. Left Ventricular Ejection Fraction (LVEF) [5 years]

79. Right Ventricular Systolic Pressure (RVSP) [Baseline]

80. Right Ventricular Systolic Pressure (RVSP) [At discharge (or 30 days if discharge echocardiogram is not available)]

81. Right Ventricular Systolic Pressure (RVSP) [6 months]

82. Right Ventricular Systolic Pressure (RVSP) [12 months]

83. Right Ventricular Systolic Pressure (RVSP) [24 months]

84. Right Ventricular Systolic Pressure (RVSP) [3 years]

85. Right Ventricular Systolic Pressure (RVSP) [4 years]

86. Right Ventricular Systolic Pressure (RVSP) [5 years]

87. Mitral Valve Area [Baseline]

88. Mitral Valve Area [At discharge (or 30 days if discharge echocardiogram is not available)]

89. Mitral Valve Area [6 months]

90. Mitral Valve Area [12 months]

91. Mitral Valve Area [24 months]

92. Mitral Valve Area [3 years]

93. Mitral Valve Area [4 years]

94. Mitral Valve Area [5 years]

95. Mean Mitral Valve Gradient [Baseline]

    The normal area of the mitral valve orifice is about 4-6 cm2 when the mitral valve area goes below 2 cm2, the valve causes an impediment to the flow of blood into the left ventricle, creating a pressure gradient (mitral valve gradient) across the mitral valve. This gradient may increase by the rise in heart rate or cardiac output.

96. Mean Mitral Valve Gradient [At discharge (or 30 days if discharge echocardiogram is not available)]

    The normal area of the mitral valve orifice is about 4-6 cm2 when the mitral valve area goes below 2 cm2, the valve causes an impediment to the flow of blood into the left ventricle, creating a pressure gradient (mitral valve gradient) across the mitral valve. This gradient may increase by the rise in heart rate or cardiac output.

97. Mean Mitral Valve Gradient [6 months]

    The normal area of the mitral valve orifice is about 4-6 cm2 when the mitral valve area goes below 2 cm2, the valve causes an impediment to the flow of blood into the left ventricle, creating a pressure gradient (mitral valve gradient) across the mitral valve. This gradient may increase by the rise in heart rate or cardiac output.

98. Mean Mitral Valve Gradient [12 months]

    The normal area of the mitral valve orifice is about 4-6 cm2 when the mitral valve area goes below 2 cm2, the valve causes an impediment to the flow of blood into the left ventricle, creating a pressure gradient (mitral valve gradient) across the mitral valve. This gradient may increase by the rise in heart rate or cardiac output.

99. Mean Mitral Valve Gradient [24 months]

    The normal area of the mitral valve orifice is about 4-6 cm2 when the mitral valve area goes below 2 cm2, the valve causes an impediment to the flow of blood into the left ventricle, creating a pressure gradient (mitral valve gradient) across the mitral valve. This gradient may increase by the rise in heart rate or cardiac output.

100. Mean Mitral Valve Gradient [3 years]

101. Mean Mitral Valve Gradient [4 years]

102. Mean Mitral Valve Gradient [5 years]

103. Systolic Anterior Motion of the Mitral Valve (Present or Absent) [Baseline]

104. Systolic Anterior Motion of the Mitral Valve (Present or Absent) [At discharge (or 30 days if discharge echocardiogram is not available)]

105. Systolic Anterior Motion of the Mitral Valve (Present or Absent) [6 months]

106. Systolic Anterior Motion of the Mitral Valve (Present or Absent) [12 months]

107. Systolic Anterior Motion of the Mitral Valve (Present or Absent) [24 months]

108. Systolic Anterior Motion of the Mitral Valve (Present or Absent) [3 years]

109. Systolic Anterior Motion of the Mitral Valve (Present or Absent) [4 years]

110. Systolic Anterior Motion of the Mitral Valve (Present or Absent) [5 years]

111. Cardiac Output [Baseline]

     The amount of blood the heart pumps through the circulatory system in a minute.

112. Cardiac Output [At discharge (or 30 days if discharge echocardiogram is not available)]

     The amount of blood the heart pumps through the circulatory system in a minute.

113. Cardiac Output [6 months]

     The amount of blood the heart pumps through the circulatory system in a minute.

114. Cardiac Output [12 months]

     The amount of blood the heart pumps through the circulatory system in a minute.

115. Cardiac Output [24 months]

     The amount of blood the heart pumps through the circulatory system in a minute.

116. Cardiac Output [3 years]

117. Cardiac Output [4 years]

118. Cardiac Output [5 years]

119. Forward Stroke Volume [Baseline]

     Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume.

120. Forward Stroke Volume [At discharge (or 30 days if discharge echocardiogram is not available)]

     Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume.

121. Forward Stroke Volume [6 months]

     Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume.

122. Forward Stroke Volume [12 months]

     Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume.

123. Forward Stroke Volume [24 months]

     Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume.

124. Forward Stroke Volume [3 years]

125. Forward Stroke Volume [4 years]

126. Forward Stroke Volume [5 years]

127. Kaplan-Meier Freedom From the Components of the Primary Safety Composite [12 months in Device group]

     Freedom from the components of the primary safety composite of device related complications including Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, or any device related complications requiring non-elective cardiovascular surgery at 12 months will be the primary measure of safety.

128. Kaplan-Meier Freedom From the Components of the Primary Safety Composite [24 months in Device group]

     Freedom from the components of the primary safety composite of device related complications including Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, or any device related complications requiring non-elective cardiovascular surgery at 12 months will be the primary measure of safety.

129. Kaplan-Meier Freedom From the Components of the Primary Safety Composite [3 years in Device group]

130. Kaplan-Meier Freedom From the Components of the Primary Safety Composite [4 years in Device group]

131. Kaplan-Meier Freedom From the Components of the Primary Safety Composite [5 years in Device group]

132. Kaplan-Meier Freedom From the Primary Safety Composite [24 months in Device group]

     Freedom from the primary safety composite of device related complications including Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, or any device related complications requiring non-elective cardiovascular surgery at 12 months will be the primary measure of safety.

133. Kaplan-Meier Freedom From the Primary Safety Composite [3 years in Device group]

134. Kaplan-Meier Freedom From the Primary Safety Composite [4 years in Device group]

135. Kaplan-Meier Freedom From the Primary Safety Composite [5 years in Device group]

136. Kaplan-Meier Freedom From All-cause Mortality [24 months]

     Kaplan-Meier survival rate for all cause mortality at 24 months

137. Kaplan-Meier Freedom From All-cause Mortality [3 years]

138. Kaplan-Meier Freedom From All-cause Mortality [4 years]

139. Kaplan-Meier Freedom From All-cause Mortality [5 years]

140. Kaplan-Meier Freedom From Cardiovascular Mortality [12 months]

     Kaplan-Meier survival rate for Cardiovascular mortality.

141. Kaplan-Meier Freedom From Cardiovascular Mortality [24 months]

     Kaplan-Meier survival rate for Cardiovascular mortality.

142. Kaplan-Meier Freedom From Cardiovascular Mortality [3 years]

143. Kaplan-Meier Freedom From Cardiovascular Mortality [4 years]

144. Kaplan-Meier Freedom From Cardiovascular Mortality [5 years]

145. Kaplan-Meier Freedom From the First HF Related Hospitalization [12 months]

146. Kaplan-Meier Freedom From the First HF Related Hospitalization [24 months]

147. Kaplan-Meier Freedom From the First HF Related Hospitalization [3 years]

148. Kaplan-Meier Freedom From the First HF Related Hospitalization [4 years]

149. Kaplan-Meier Freedom From the First HF Related Hospitalization [5 years]

150. Kaplan-Meier Freedom From the First Cardiovascular Hospitalization [12 months]

151. Kaplan-Meier Freedom From the First Cardiovascular Hospitalization [24 months]

152. Kaplan-Meier Freedom From the First Cardiovascular Hospitalization [3 years]

153. Kaplan-Meier Freedom From the First Cardiovascular Hospitalization [4 years]

154. Kaplan-Meier Freedom From the First Cardiovascular Hospitalization [5 years]

155. Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality [12 months]

156. Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality [24 months]

     Survival rate from the first HF related hospitalization or all-cause mortality.

157. Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality [3 years]

158. Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality [4 years]

159. Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality [5 years]

160. NYHA Functional Class [Baseline]

     Measure Description: The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I: No symptoms and no limitation in ordinary physical activity Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity Class III: Marked limitation in activity due to symptoms Class IV: Severe limitations

161. NYHA Functional Class [30 days]

     Measure Description: The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I: No symptoms and no limitation in ordinary physical activity Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity Class III: Marked limitation in activity due to symptoms Class IV: Severe limitations

162. NYHA Functional Class [6 months]

     Measure Description: The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I: No symptoms and no limitation in ordinary physical activity Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity Class III: Marked limitation in activity due to symptoms Class IV: Severe limitations

163. NYHA Functional Class [12 months]

     Measure Description: The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I: No symptoms and no limitation in ordinary physical activity Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity Class III: Marked limitation in activity due to symptoms Class IV: Severe limitations

164. NYHA Functional Class [24 months]

     Measure Description: The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I: No symptoms and no limitation in ordinary physical activity Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity Class III: Marked limitation in activity due to symptoms Class IV: Severe limitations

165. NYHA Functional Class [3 years]

166. NYHA Functional Class [4 years]

167. NYHA Functional Class [5 years]

168. Six-Minute Walk Test Distance (6MWD) [Baseline]

     Six-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk test distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.

169. 6MWD [30 days]

     Six-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk test distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.

170. 6MWD [6 months]

     Six-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk test distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.

171. 6MWD [12 months]

     Six-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk test distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.

172. 6MWD [24 months]

     Six-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk test distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.

173. Change in 6MWD From Baseline [Between baseline and 30 days]

174. Change in 6MWD From Baseline [Between baseline and 6 months]

175. Change in 6MWD From Baseline [Between baseline and 12 months]

176. Change in 6MWD From Baseline [Between baseline and 24 months]

177. Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores [Baseline]

     The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

178. KCCQ QoL Scores [30 days]

     The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

179. KCCQ QoL Scores [6 months]

     The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

180. KCCQ QoL Scores [12 months]

     The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

181. KCCQ QoL Scores [24 months]

     The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

182. Change in KCCQ QoL Scores From Baseline [Between baseline and 30 days]

     Paired data looking at difference between the baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and 30 days KCCQ score. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

183. Change in KCCQ QoL Scores From Baseline [Between baseline and 6 months]

     Paired data looking at difference between the baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and 6 months KCCQ score. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

184. Change in KCCQ QoL Scores From Baseline [Between baseline and 12 months]

     Paired data looking at difference between the baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and 12 months KCCQ score. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

185. Change in KCCQ QoL Scores From Baseline [Between baseline and 24 months]

     Paired data looking at difference between the baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and 24 months KCCQ score. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

186. SF-36 QoL Scores [Baseline]

     The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).

187. SF-36 QoL Scores [30 days]

     The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).

188. SF-36 QoL Scores [6 months]

     The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).

189. SF-36 QoL Scores [12 months]

     The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).

190. SF-36 QoL Scores [24 months]

     The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).

191. Change in SF-36 QoL Scores From Baseline [Between baseline and 30 days]

     Paired data looking at difference between the baseline SF-36 and 30 days SF-36. The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).

192. Change in SF-36 QoL Scores From Baseline [Between baseline and 6 months]

     Paired data looking at difference between the baseline SF-36 and 6 months days SF-36. The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).

193. Change in SF-36 QoL Scores From Baseline [Between baseline and 12 months]

     Paired data looking at difference between the baseline SF-36 and 12 month SF-36. The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).

194. Change in SF-36 QoL Scores From Baseline [Between baseline and 24 months]

     Paired data looking at difference between the baseline SF-36 and 24 months SF-36. The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).

195. Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group [Through 5 years]

196. De Novo MitraClip Device Intervention in Control Group [Through 5 years]

197. Responder Analysis for 6MWD [12 months]

     Where responder is defined as alive and experiencing an improvement of 24 meters and 50 meters (difference in proportion of responders between Device and Control groups)

198. Responder Analysis for 6MWD [24 months]

     Where responder is defined as alive and experiencing an improvement of 24 meters and 50 meters (difference in proportion of responders between Device and Control groups)

199. Responder Analysis for LVEDV Index [12 months]

     Where responder is defined as alive and experiencing an improvement of 12 ml/m2 (difference in proportion of responders between Device and Control groups)

200. Responder Analysis for LVEDV Index [24 months]

     Where responder is defined as alive and experiencing an improvement of 12 ml/m2 (difference in proportion of responders between Device and Control groups)

201. Responder Analysis for LVEDV Index [3 years]

     Where responder is defined as alive and experiencing an improvement of 12 ml/m2 (difference in proportion of responders between Device and Control groups)

202. Responder Analysis for LVEDV Index [4 years]

     Where responder is defined as alive and experiencing an improvement of 12 ml/m2 (difference in proportion of responders between Device and Control groups)

203. Responder Analysis for LVEDV Index [5 years]

     Where responder is defined as alive and experiencing an improvement of 12 ml/m2 (difference in proportion of responders between Device and Control groups)

204. Responder Analysis for QoL (KCCQ) [12 months]

     Where responder is defined as alive and experiencing an improvement of 5 points (difference in proportion of responders between Device and Control groups)

205. Responder Analysis for QoL (KCCQ) [24 months]

     Where responder is defined as alive and experiencing an improvement of 5 points (difference in proportion of responders between Device and Control groups)

206. Each Subscale for QoL (KCCQ) [12 months]

     difference in means between Device and Control groups for the Kansas City Cardiomyopathy Questionnaire (KCCQ) for the physical limitation and symptom stability scores.

207. Each Subscale for QoL (KCCQ) [24 months]

     difference in means between Device and Control groups for the Kansas City Cardiomyopathy Questionnaire (KCCQ) for the physical limitation and symptom stability scores.

208. Length of Index Hospitalization for MitraClip Procedure (Device Group) [Before MitraClip procedure on day 0]

     Length of stay in the hospital for the MitraClip Index procedure (device group)

209. Number of Hospitalizations and Reason for Hospitalization (i.e. Heart Failure, Cardiovascular, Non-cardiovascular) [12 months]

     in each of the Device and Control groups

210. Number of Hospitalizations and Reason for Hospitalization (i.e. Heart Failure, Cardiovascular, Non-cardiovascular) [24 months]

     in each of the Device and Control groups

211. Number of Days Alive and Out of Hospital [From the time of randomization to 12 months]

     difference in mean between Device and Control groups

212. Number of Days Alive and Out of Hospital [From the time of randomization to 24 months]

     difference in means between Device and Control groups

213. Number of Days Alive and Out of Hospital [From the time of randomization to 3 Years]

     difference in medians between Device and Control groups

214. Number of Days Alive and Out of Hospital [From the time of randomization to 4 Years]

     difference in medians between Device and Control groups

215. Number of Days Alive and Out of Hospital [From the time of randomization to 5 Years]

     difference in medians between Device and Control groups

216. Number of Days Hospitalized From the "Treatment" Visit [12 months]

     difference in means between Device and Control groups

217. Number of Days Hospitalized From the "Treatment" Visit [24 months]

     difference in means between Device and Control groups

218. Number of Days Hospitalized From the "Treatment" Visit [3 Years]

     difference in medians between Device and Control groups

219. Number of Days Hospitalized From the "Treatment" Visit [4 Years]

     difference in medians between Device and Control groups

220. Number of Days Hospitalized From the "Treatment" Visit [5 Years]

     difference in medians between Device and Control groups

221. Proportion of Alive Time in Hospital [12 months]

     summarized and compared between Device and Control groups

222. Proportion of Alive Time in Hospital [24 months]

     summarized and compared between Device and Control groups

223. Proportion of Alive Time in Hospital [3 years]

     summarized and compared between Device and Control groups

224. Proportion of Alive Time in Hospital [4 years]

     summarized and compared between Device and Control groups

225. Proportion of Alive Time in Hospital [5 years]

     summarized and compared between Device and Control groups

226. Proportion of Subjects Living in the Baseline Location [12 months]

     Subjects living in the baseline location include : home, retirement home, nursing facility and other location.

227. Proportion of Subjects Living in the Baseline Location [24 months]

     Subjects living in the baseline location include : home, retirement home, nursing facility and other location.

228. Proportion of Subjects Living in the Baseline Location [3 years]

229. Proportion of Subjects Living in the Baseline Location [4 years]

230. Proportion of Subjects Living in the Baseline Location [5 years]

231. Mitral Valve Replacement Rates [12 months]

     Subjects with mitral valve replacements in the Device and Control groups

232. Mitral Valve Replacement Rates [24 months]

     Subjects with mitral valve replacements in the Device and Control groups

233. Mitral Valve Replacement Rates [3 years]

     summarized and compared between Device and Control groups

234. Mitral Valve Replacement Rates [4 years]

     summarized and compared between Device and Control groups

235. Mitral Valve Replacement Rates [5 years]

     summarized and compared between Device and Control groups

236. New Onset of Permanent Atrial Fibrillation [12 months]

237. New Onset of Permanent Atrial Fibrillation [24 months]

238. New Onset of Permanent Atrial Fibrillation [3 years]

239. New Onset of Permanent Atrial Fibrillation [4 years]

240. New Onset of Permanent Atrial Fibrillation [5 years]

241. Mitral Stenosis [12 months]

     Defined as a mitral valve orifice area of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory

242. Mitral Stenosis [24 months]

     Defined as a mitral valve orifice area of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory

243. Mitral Stenosis [3 years]

     Defined as a mitral valve orifice area of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory

244. Mitral Stenosis [4 years]

     Defined as a mitral valve orifice area of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory

245. Mitral Stenosis [5 years]

     Defined as a mitral valve orifice area of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory

246. Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention [12 months]

247. Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention [24 months]

248. Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention [3 years]

249. Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention [4 years]

250. Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention [5 years]

251. Device-related Complications in Device Group Subjects and Control Group Subjects Who Undergo the MitraClip Procedure [Through 5 years]

252. Brain Natriuretic Peptide (BNP) or N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP Levels) [Baseline]

253. BNP or NT-proBNP Levels [30 days]

254. BNP or NT-proBNP Levels [12 months]

255. Modified Rankin Scale Score [Baseline]

     MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead

256. Modified Rankin Scale Score [30 days]

     MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead

257. Modified Rankin Scale Score [6 months]

     MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead

258. Modified Rankin Scale Score [12 months]

     MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead

259. Major Bleeding [30 days]

     Major bleeding is defined as bleeding ≥ Type 3 based on a modified Bleeding Academic Research Consortium (BARC) definition

260. Prolonged Ventilation [30 days]

     Defined as pulmonary insufficiency requiring ventilatory support for greater than 48 hours post-catheterization

261. Average Dosages of Guideline Directed Medical Therapy (GDMT) [Baseline]

262. Average Dosages of GDMT [30 days]

263. Average Dosages of GDMT [6 months]

264. Average Dosages of GDMT [12 months]

265. Average Dosages of GDMT [24 months]

266. Average Dosages of GDMT [3 years]

267. Average Dosages of GDMT [4 years]

268. Average Dosages of GDMT [5 years]

269. The Number of Subjects With Changes in GDMT Dosage From Baseline [Between baseline and 30 days]

270. The Number of Subjects With Changes in GDMT Dosage From Baseline to 6 Months [Between baseline and 6 months]

271. The Number of Subjects With Changes in GDMT Dosage From Baseline and 12 Months [Between baseline and 12 months]

272. The Number of Subjects With Changes in GDMT Dosage From Baseline and 24 Months [Between baseline and 24 months]

273. The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline [Between baseline and 3 years]

274. The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline [Between baseline and 4 years]

275. The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline [Between baseline and 5 years]

276. The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose [Between baseline and 30 days]

277. The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose [Between baseline and 6 months]

278. The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose [Between baseline and 12 months]

279. The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose [Between baseline and 24 months]

280. The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose [Between baseline and 3 years]

281. The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose [Between baseline and 4 years]

282. The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose [Between baseline and 5 years]

283. Cardiopulmonary Exercise (CPX) Testing [Baseline]

     A substudy endpoint will utilize peak oxygen consumption oxygen uptake (VO2) as a parameter for cardiopulmonary exercise testing on a total of at least 50 and up to 100 subjects. The CPX analysis variables are: Peak VO2 (ml/kg/min) - CPX Sub-study endpoint, descriptive analysis only, not powered for statistical significance Exercise duration (min) Peak workload (watts) Maximum heart rate during exercise (beats/min) Peak VE (l/min) Respiratory Exchange Ratio (RER, VCO2/VO2) VE/VCO2 slope Ventilatory Threshold (ml/kg/min) Borg scale Exercise termination reason Type of exercise (treadmill vs cycling)

284. Cardiopulmonary Exercise (CPX) Testing [12 months]

     A substudy endpoint will utilize peak oxygen consumption oxygen uptake (VO2) as a parameter for cardiopulmonary exercise testing on a total of at least 50 and up to 100 subjects. The CPX analysis variables are: Peak VO2 (ml/kg/min) - CPX Sub-study endpoint, descriptive analysis only, not powered for statistical significance Exercise duration (min) Peak workload (watts) Maximum heart rate during exercise (beats/min) Peak VE (l/min) Respiratory Exchange Ratio (RER, VCO2/VO2) VE/VCO2 slope Ventilatory Threshold (ml/kg/min) Borg scale Exercise termination reason Type of exercise (treadmill vs cycling)

285. Cardiopulmonary Exercise (CPX) Testing: Mean Changes in Peak VO2 [Between baseline and 12 months]

     Mean changes in peak VO2 (ml/kg/min) will be summarized at 12 months from baseline for the subset of patients who complete a CPX test at baseline and 12 months. A comparison of change from baseline between Device and Control groups will be presented. The CPX analysis variables are: Peak VO2 (ml/kg/min) - CPX Sub-study endpoint, descriptive analysis only, not powered for statistical significance Exercise duration (min) Peak workload (watts) Maximum heart rate during exercise (beats/min) Peak VE (l/min) Respiratory Exchange Ratio (RER, VCO2/VO2) VE/VCO2 slope Ventilatory Threshold (ml/kg/min) Borg scale Exercise termination reason Type of exercise (treadmill vs cycling)

286. Health Economic Data [Through 5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Symptomatic functional MR (≥3+) due to cardiomyopathy of either ischemic or non-ischemic etiology determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 90 days and transesophageal echocardiogram (TEE) obtained within 180 days prior to subject registration, with MR severity based principally on the TTE study, confirmed by the Echocardiography Core Lab (ECL). The ECL may request a transesophageal echocardiogram (TEE) to confirm MR etiology.

Note: Functional MR requires the presence of global or regional left ventricular wall motion abnormalities, which are believed to be the primary cause of the MR. If a flail leaflet or other evidence of degenerative MR is present, the subject is not eligible even if global or regional left ventricular systolic dysfunction is present.

Note: Qualifying TTE must be obtained after the subject has been stabilized on optimal therapy including Guideline Directed Medical Therapy (GDMT) and at least 30 days after:

1. a greater than 100% increase or greater than 50% decrease in dose of GDMT

2. revascularization and/or implant of Cardiac Resynchronization Therapy device (CRT or CRT-D) or reprogramming of an implanted CRT or CRT-D that results in increased biventricular pacing (from <92% to ≥92%)

3. In the judgment of the HF specialist investigator at the site, the subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, mitral regurgitation and heart failure (e.g., with cardiac resynchronization therapy, revascularization, and/or GDMT). The Eligibility Committee must also concur that the subject has been adequately treated.

4. New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.

5. The Local Site Heart Team (CT surgeon and HF specialist investigators) and the Central Eligibility Committee concur that surgery will not be offered as a treatment option and that medical therapy is the intended therapy for the subject, even if the subject is randomized to the Control group.

6. The subject has had at least one hospitalization for heart failure in the 12 months prior to subject registration and/or a corrected brain natriuretic peptide (BNP) ≥300 pg/ml or corrected n-Terminal pro- brain natriuretic peptide NT-proBNP ≥1500 pg/ml measured within 90 days prior to subject registration ("corrected" refers to a 4% reduction in the BNP or NT-proBNP cutoff for every increase of 1 kg/m2 in BMI above a reference BMI of 20 kg/m2).

Note: BNP or NT-proBNP must be obtained after the subject has been stabilized on GDMT and at least 30 days after:

1. a greater than 100% increase or greater than 50% decrease in dose of GDMT

2. revascularization and/or implant of Cardiac Resynchronization Therapy device (CRT or CRT-D) or reprogramming of an implanted CRT or CRT-D that results in increased biventricular pacing (from <92% to ≥92%).

3. Left Ventricular Ejection Fraction (LVEF) is ≥20% and ≤50% within 90 days prior to subject registration, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI).

Note: The method must provide a quantitative readout (not a visual assessment).

1. The primary regurgitant jet is non-commissural, and in the opinion of the MitraClip implanting investigator can be successfully be treated by the MitraClip. If a secondary jet exists, it must be considered clinically insignificant.

2. Creatine Kinase-MB (CK-MB) obtained within prior 14 days < local laboratory Upper Limit of Normal (ULN).

3. Transseptal catheterization and femoral vein access is determined to be feasible by the MitraClip implanting investigator.

4. Age 18 years or older.

5. The subject or the subject's legal representative understands and agrees that should he/she be assigned to the Control group, he/she will be treated with medical therapy and conservative management without surgery and without the MitraClip, either domestically or abroad. If the subject would actively contemplate surgery and/or MitraClip if randomized to Control, he/she should not be registered in this trial.

6. The subject or the subject's legal representative has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent.

7. Left Ventricular End Systolic Dimension (LVESD) is ≤ 70 mm assessed by site based on a transthoracic echocardiographic (TTE) obtained within 90 days prior to subject registration.

For the CPX Sub-study: Subjects have to meet the COAPT study eligibility criteria to be registered in the CPX Sub-study.

COAPT CAS study Inclusion Criteria:

1. Subjects must meet all of the above COAPT RCT inclusion criteria, and must have national Medicare coverage by the Centers for Medicare and Medicaid Services (CMS).

Exclusion Criteria:

1. Chronic Obstructive Pulmonary Disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use.

2. Untreated clinically significant coronary artery disease requiring revascularization.

3. Coronary artery bypass grafting (CABG) within 30 days prior to subject registration.

4. Percutaneous coronary intervention within 30 days prior to subject registration.

5. Transcatheter aortic valve replacement (TAVR) within 30 days prior to subject registration.

6. Tricuspid valve disease requiring surgery or transcatheter intervention.

7. Aortic valve disease requiring surgery.

8. Cerebrovascular accident within 30 days prior to subject registration.

9. Severe symptomatic carotid stenosis (> 70% by ultrasound).

10. Carotid surgery or stenting within 30 days prior to subject registration.

11. American College of Cardiology /American Heart Association (ACC/AHA) Stage D heart failure.

12. Presence of any of the following:

• Estimated pulmonary artery systolic pressure (PASP) > 70 mm Hg assessed by site based on echocardiography or right heart catheterization, unless active vasodilator therapy in the cath lab is able to reduce the pulmonary vascular resistance (PVR) to < 3 Wood Units or between 3 and 4.5 Wood Units with v wave less than twice the mean of the pulmonary capillary wedge pressure

• Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non ischemic etiology

• Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis)

• Hemodynamic instability requiring inotropic support or mechanical heart assistance.

1. Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction as assessed by site.

2. Implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) within the last 30days prior to subject registration.

3. Mitral valve orifice area < 4.0 cm2 assessed by site based on a transthoracic echocardiogram (TTE) within 90 days prior to subject registration.

4. Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip. This evaluation is based on transesophageal echocardiogram (TEE) evaluation of the mitral valve within 180 days prior to subject registration and includes:

• Insufficient mobile leaflet available for grasping with the MitraClip device

• Evidence of calcification in the grasping area

• Presence of a significant cleft in the grasping area

• Lack of both primary and secondary chordal support in the grasping area

• Leaflet mobility length < 1 cm

1. Hemodynamic instability defined as systolic pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device.

2. Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.

3. Life expectancy < 12 months due to non-cardiac conditions.

4. Modified Rankin Scale ≥ 4 disability.

5. Status 1 heart transplant or prior orthotopic heart transplantation.

6. Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure.

7. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.

8. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated).

9. Active infections requiring current antibiotic therapy.

10. Subjects in whom transesophageal echocardiography (TEE) is contraindicated or high risk.

11. Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically.

12. Pregnant or planning pregnancy within next 12 months.

Note: Female patients of childbearing age should be instructed to use safe contraception (e.g. intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release.

1. Currently participating in an investigational drug or another device study that has not reached its primary endpoint. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.

2. Subject belongs to a vulnerable population per investigator's judgment or subject has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures.

For the CPX Sub-study: Subjects who have any contraindications to CPX and are not capable of performing CPX per investigator's assessment should not be registered in the CPX Sub-study.

COAPT CAS study Exclusion Criteria:

1. Subjects must not meet any of the above COAPT RCT exclusion criteria.

.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233
2	Banner Good Samaritan Medical Center	Phoenix	Arizona	United States	85006
3	Scottsdale Healthcare Hospitals	Scottsdale	Arizona	United States	85258
4	Scripps Green Hospital	La Jolla	California	United States	92037
5	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
6	El Camino Hospital	Mountain View	California	United States	94040
7	University California Davis Medical Center	Sacramento	California	United States	95817
8	Kaiser Permanente - San Francisco Hospital	San Francisco	California	United States	94115
9	Stanford Hospital and Clinics	Stanford	California	United States	94305
10	University of Colorado Hospital	Denver	Colorado	United States	80045
11	Hartford Hospital	Hartford	Connecticut	United States	06106
12	Yale - New Haven Hospital	New Haven	Connecticut	United States	06510
13	Medstar Washington Hospital Center	Washington	District of Columbia	United States	20010
14	Morton Plant Hospital	Clearwater	Florida	United States	33756
15	Mount Sinai Medical Center	Miami	Florida	United States	33140
16	Florida Hospital Orlando	Orlando	Florida	United States	32803
17	Sarasota Memorial Hospital	Sarasota	Florida	United States	34239
18	Tallahassee Memorial Hospital	Tallahassee	Florida	United States	32308
19	Tampa General Hospital	Tampa	Florida	United States	33606
20	Piedmont Hospital Atlanta	Atlanta	Georgia	United States	30309
21	Emory University Hospital	Atlanta	Georgia	United States	30322
22	The Queen's Medical Center	Honolulu	Hawaii	United States	96813
23	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611
24	Rush University Medical Center	Chicago	Illinois	United States	60612
25	Evanston Hospital	Evanston	Illinois	United States	60201
26	St. Vincent Heart Center of Indiana	Indianapolis	Indiana	United States	46290
27	Iowa Heart Center	Des Moines	Iowa	United States	50266
28	University of Kansas Hosp Authority	Kansas City	Kansas	United States	66160
29	Via Christi	Wichita	Kansas	United States	66866
30	St. Joseph's Hospital - Lexington, KY	Lexington	Kentucky	United States	40504
31	Jewish Hospital	Louisville	Kentucky	United States	40245
32	Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
33	Maine Medical Center	Portland	Maine	United States	04102
34	University of Maryland Baltimore	Baltimore	Maryland	United States	21201
35	Tufts Medical Center	Boston	Massachusetts	United States	02111
36	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
37	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
38	University of Michigan Hospitals	Ann Arbor	Michigan	United States	48109
39	Henry Ford Hospital	Detroit	Michigan	United States	48202
40	William Beaumont Hospital	Royal Oak	Michigan	United States	48073-6796
41	Abbott Northwestern Hospital	Minneapolis	Minnesota	United States	55407
42	University of Minnesota	Minneapolis	Minnesota	United States	55455
43	Mayo Foundation for Med Edu And Research	Rochester	Minnesota	United States	55905
44	Saint Luke's Hospital	Kansas City	Missouri	United States	64111
45	Barnes Jewish Hospital	Saint Louis	Missouri	United States	63110
46	St. Patrick Hospital	Missoula	Montana	United States	59802
47	Nebraska Heart Institute Heart Hospital	Lincoln	Nebraska	United States	68526
48	Cooper University Hospital	Camden	New Jersey	United States	08103
49	Morristown Medical Center	Morristown	New Jersey	United States	07960
50	North Shore	Manhasset	New York	United States	11030
51	NYU Langone Medical Center	New York	New York	United States	10016
52	Mount Sinai Medical Center	New York	New York	United States	10029
53	Columbia University Medical Center / New York Presbyterian Hospital	New York	New York	United States	10032
54	NYP Weill Cornell Medical Center	New York	New York	United States	10065
55	St. Francis Hospital	Roslyn	New York	United States	11576
56	Carolinas Medical Center	Charlotte	North Carolina	United States	28203
57	Duke University Medical Center	Durham	North Carolina	United States	27710
58	Vidant Medical Center	Greenville	North Carolina	United States	27834
59	The Christ Hospital	Cincinnati	Ohio	United States	45219
60	Cleveland Clinic	Cleveland	Ohio	United States	44195
61	Ohio State University Medical Center	Columbus	Ohio	United States	43210
62	Riverside Methodist Hospital	Columbus	Ohio	United States	43214-3907
63	Oklahoma Heart Hospital	Oklahoma City	Oklahoma	United States	73120
64	Providence St. Vincent Medical Center	Portland	Oregon	United States	97225
65	Oregon Health and Science University	Portland	Oregon	United States	97239
66	Hospital of University Pennsylvania	Philadelphia	Pennsylvania	United States	19104
67	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140
68	UPMC Presbyterian	Pittsburgh	Pennsylvania	United States	15213
69	Pinnacle Health at Harrisburg Hospital	Wormleysburg	Pennsylvania	United States	17043
70	Medical University of South Carolina	Charleston	South Carolina	United States	29403
71	St. Thomas Hospital	Nashville	Tennessee	United States	37205
72	Seton Medical Center Austin	Austin	Texas	United States	78705
73	Baylor Heart and Vascular Hospital	Dallas	Texas	United States	75204
74	UT Southwestern Medical Center	Dallas	Texas	United States	75235
75	Houston Methodist Hospital	Houston	Texas	United States	77030
76	Memorial Hermann Hospital	Houston	Texas	United States	77030
77	Intermountain Medical Center	Murray	Utah	United States	84107
78	University of Virginia	Charlottesville	Virginia	United States	22908
79	Virginia Commonwealth University Medical Center	Richmond	Virginia	United States	23284
80	Carilion Roanoke Memorial Hospital	Roanoke	Virginia	United States	24014
81	Swedish Medical Center Cherry Hill Campus	Seattle	Washington	United States	98122
82	St Paul's - Providence Health Care	Vancouver	British Columbia	Canada	V6Z 1Y6
83	Hamilton Health Sciences	Hamilton	Ontario	Canada	L8L 2X2
84	St Michael's Hospital	Toronto	Ontario	Canada	M5B 1W8
85	Montreal Heart Institute	Montreal	Quebec	Canada	H1T 1C8
86	University of Alberta	Edmonton		Canada

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Michael Mack, MD, Baylor Health Care System
• Principal Investigator: Gregg Stone, MD, Columbia University Medical Center / New York-Presbyterian Hospital
• Principal Investigator: William T Abraham, MD, The Ohio State University Heart Center
• Principal Investigator: JoAnn Lindenfeld, MD, Vanderbilt University Medical Center

Study Documents (Full-Text)

• Study Protocol - Oct 12, 2016
• Statistical Analysis Plan - Jun 4, 2018

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT01626079
• Other Study ID Numbers: 11-512
• First Posted: Jun 22, 2012
• Last Update Posted: Jan 8, 2021
• Last Verified: Apr 1, 2020

• Keywords provided by Abbott Medical Devices: Functional Mitral Regurgitation; Mitral Valve Regurgitation; Symptomatic Heart Failure; Functional MR; MitraClip; Mitral Valve Insufficiency; Cardiopulmonary exercise testing; COAPT CAS; COAPT Continued Access Study; MitraClip NT
• Additional relevant MeSH terms: Heart Failure; Mitral Valve Insufficiency

Study Results

Participant Flow

Recruitment Details	In COAPT, 614 subjects were randomized. Enrollment concluded on June 23, 2017. Of the 614 randomized subjects, 302 were in Device group and 312 in the Control group. Subject follow-up is on-going.
Pre-assignment Detail	This section includes the results for the primary safety, primary effectiveness, and the 10 secondary endpoints that are the most essential outcomes of the trial.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Period Title: Overall Study
STARTED	302	312
COMPLETED	135	96
NOT COMPLETED	167	216

Baseline Characteristics

Arm/Group Title	MitraClip System	Control Group	Total
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.	Total of all reporting groups
Overall Participants	302	312	614
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71.7 (11.8)	72.8 (10.5)	72.2 (11.2)
Sex: Female, Male (Count of Participants)
Female	101 33.4%	120 38.5%	221 36%
Male	201 66.6%	192 61.5%	393 64%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	6 2%	12 3.8%	18 2.9%
Black or African American	44 14.6%	44 14.1%	88 14.3%
Hispanic or Latino	20 6.6%	20 6.4%	40 6.5%
Native Hawaiian or Other Pacific Islander	1 0.3%	0 0%	1 0.2%
White or Caucasian	225 74.5%	232 74.4%	457 74.4%
Other	6 2%	4 1.3%	10 1.6%
Region of Enrollment (participants) [Number]
Canada	12 4%	14 4.5%	26 4.2%
United States	290 96%	298 95.5%	588 95.8%
Height (Cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Cm]	170.84 (10.35)	169.86 (10.75)	170.34 (10.56)
Weight (Kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kg]	78.79 (17.23)	78.40 (20.06)	78.59 (18.70)
Body Mass Index (kg/m^2) (Kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kg/m^2]	27.04 (5.81)	27.05 (5.96)	27.05 (5.88)
Serum Creatinine (mg/dL) ((mg/dL)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [(mg/dL)]	1.77 (1.22)	1.80 (1.42)	1.79 (1.32)
Creatinine Clearance (mL/min) (mL/min) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mL/min]	50.87 (28.48)	47.76 (24.97)	49.31 (26.79)
Creatinine Clearance <= 60mL/min (Count of Participants)
Count of Participants [Participants]	214 70.9%	227 72.8%	441 71.8%
Brain Natriuretic Peptide (Pg/mL) (Pg/mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Pg/mL]	1014.77 (1085.98)	1017.13 (1212.77)	1015.95 (1149.89)
NT-proBNP (pg/mL) (pg/mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pg/mL]	5174.33 (6566.61)	5943.86 (8437.61)	5585.71 (7610.56)
Elevated BNP or NT-BNP prior to Enrollment (Count of Participants)
Count of Participants [Participants]	267 88.4%	282 90.4%	549 89.4%
Extremely High Risk for MV Surgery (Count of Participants)
Count of Participants [Participants]	205 67.9%	218 69.9%	423 68.9%
Diabetes (Count of Participants)
Count of Participants [Participants]	106 35.1%	123 39.4%	229 37.3%
Hypertension (Count of Participants)
Count of Participants [Participants]	243 80.5%	251 80.4%	494 80.5%
Hypercholesterolemia (Count of Participants)
Count of Participants [Participants]	166 55%	163 52.2%	329 53.6%
Previous Myocardial Infarction (Count of Participants)
Count of Participants [Participants]	156 51.7%	160 51.3%	316 51.5%
Previous Percutaneous Coronary Intervention (Count of Participants)
Count of Participants [Participants]	130 43%	153 49%	283 46.1%
Previous Coronary Artery Bypass Grafting (Count of Participants)
Count of Participants [Participants]	121 40.1%	126 40.4%	247 40.2%
Previous Stroke or Transient Ischemic Attack (Count of Participants)
Count of Participants [Participants]	56 18.5%	49 15.7%	105 17.1%
Peripheral Vascular Disease (Count of Participants)
Count of Participants [Participants]	52 17.2%	57 18.3%	109 17.8%
Chronic Obstructive Pulmonary Disease (Count of Participants)
Count of Participants [Participants]	71 23.5%	72 23.1%	143 23.3%
History of Atrial Fibrillation or Flutter (Count of Participants)
Count of Participants [Participants]	173 57.3%	166 53.2%	339 55.2%
Anemia (Count of Participants)
Count of Participants [Participants]	180 59.6%	192 61.5%	372 60.6%
STS Risk Score (percentage of expected mortality) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage of expected mortality]	7.83 (5.53)	8.5 (6.15)	8.17 (5.86)
STS Risk Score >= 8% (Count of Participants)
Count of Participants [Participants]	126 41.7%	136 43.6%	262 42.7%
Risk of Surgery-related complications or death (Count of Participants)
High	205 67.9%	218 69.9%	423 68.9%
Not High	94 31.1%	94 30.1%	188 30.6%
Cardiomyopathy (Count of Participants)
Ischemic	184 60.9%	189 60.6%	373 60.7%
Non-Ischemic	118 39.1%	123 39.4%	241 39.3%
New York Heart Association (NYHA) Classification (Count of Participants)
NYHA Class I	1 0.3%	0 0%	1 0.2%
NYHA Class II	129 42.7%	110 35.3%	239 38.9%
NYHA Class III	154 51%	168 53.8%	322 52.4%
NYHA Class IVa, ambulatory	18 6%	33 10.6%	51 8.3%
Hospitalization for Heart Failure within Previous 1 yr (Count of Participants)
Count of Participants [Participants]	176 58.3%	175 56.1%	351 57.2%
Previous Cardiac Resynchronization Therapy (Count of Participants)
Count of Participants [Participants]	115 38.1%	109 34.9%	224 36.5%
Previous Implantation of Defibrillator (Count of Participants)
Count of Participants [Participants]	91 30.1%	101 32.4%	192 31.3%
Severity of Mitral Regurgitation (Count of Participants)
Moderate-to-severe, grade 3+	148 49%	172 55.1%	320 52.1%
Severe, grade 4+	154 51%	139 44.6%	293 47.7%
Effective Regurgitat Orifice Area (Cm2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Cm2]	0.41 (0.15)	0.40 (0.15)	0.41 (0.15)
Left Ventricular End Systolic Dimension (Diameter) (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	5.28 (0.86)	5.30 (0.89)	5.29 (0.87)
Left Ventricular End-Diastolic Dimension (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	6.17 (0.73)	6.19 (0.75)	6.18 (0.74)
Left Ventricular End-Systolic Volume (mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mL]	135.5 (56.1)	134.3 (60.3)	134.9 (58.2)
Left Ventricular End-Diastolic Volume (mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mL]	194.4 (69.2)	191.0 (72.9)	192.7 (71.0)
Left Ventricular Ejection Fraction (%) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [%]	31.32 (9.07)	31.30 (9.58)	31.31 (9.32)
LVEF >= 40% (Count of Participants)
Count of Participants [Participants]	231 76.5%	241 77.2%	472 76.9%
Right Ventricular Systolic Pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	43.95 (13.44)	44.56 (13.96)	44.26 (13.70)

Outcome Measures

1. Primary Outcome

Title	Primary Safety Endpoint - Percentage of Participants With Freedom From Device Related Complications at 12 Months
Description	Percentage of Participants with Freedom from Device related Complications at 12 Months. Composite of Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, and any device related complications requiring non-elective cardiovascular surgery.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Subjects who were randomized with attempted procedure to the device group with available data. Performance goal was 88%.

Arm/Group Title	MitraClip System
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System
Measure Participants	293
Number (95% Confidence Interval) [percentage of participants]	0.966 0.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MitraClip System
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Two thousand (2000) simulations were performed to calculate sample size and power for the primary safety endpoint. Assuming 22% mortality and 7.5% attrition at 12 months, a total of 305 subjects in the Device group will provide > 95% power to reject the null hypothesis at the one-sided significance level of 5%.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Z test Using Kaplan Meier Survival
	Comments	P-value calculated from Z test using Kaplan Meier survival estimate together with Greenwood method estimated variance
Method of Estimation	Estimation Parameter	Kaplan Meier
	Estimated Value	0.966
	Confidence Interval	(1-Sided) 95%; 0.948 to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.011
	Estimation Comments

2. Primary Outcome

Title	Primary Effectiveness Endpoint
Description	Recurrent HF hospitalizations (HFH) through 24 months, analyzed when the last subject completes 12-month follow-up
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

302 subjects from device group and 312 subjects from the control group were analyzed for Recurrent HF hospitalizations through 24 months

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
Number [events]	160	283

3. Primary Outcome

Title	Primary Effectiveness Endpoint
Description	Recurrent HF hospitalizations (HFH) through 24 months, analyzed when the last subject completes 12-month follow-up
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

302 subjects from device group and 312 subjects from the control group were analyzed for Recurrent HF hospitalizations through 24 months

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
Count of Participants [Participants]	92 30.5%	151 48.4%

4. Secondary Outcome

Title	Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)
Description	Number of recurrent Heart Failure hospitalization events at 12 months.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

A total of 157 subjects were enrolled in the COAPT CAS study.

Arm/Group Title	MitraClip System
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System
Measure Participants	157
Number [Events]	24

5. Secondary Outcome

Title	New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis)
Description	The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms Class IV - Severe limitations.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis)
Description	The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms Class IV - Severe limitations.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

A total of 157 subjects were enrolled in the COAPT CAS study. Of them NYHA data was available for a total of 114 subjects at 30 days.

Arm/Group Title	MitraClip System
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System
Measure Participants	114
NYHA Class I	25 8.3%
NYHA Class II	53 17.5%
NYHA Class III	33 10.9%
NYHA Class IV	3 1%

7. Secondary Outcome

Title	Quality of Life (QOL) (COAPT CAS Study Analysis) Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description	COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019. Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Secondary Outcome

Title	Quality of Life (QOL) (COAPT CAS Study Analysis) Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description	The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

A total of 157 subjects were enrolled in the COAPT CAS study. Data was available for 117 subjects at 30 days.

Arm/Group Title	MitraClip System
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System
Measure Participants	117
Mean (Standard Deviation) [KCCQ score on a points scale]	61.38 (25.21)

9. Secondary Outcome

Title	Six Minute Walk Test (6MWT Distance or 6MWD) (COAPT CAS Study Analysis)
Description	COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019. Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Secondary Outcome

Title	Six Minute Walk Test (6MWT Distance or 6MWD) (COAPT CAS Study Analysis)
Description	The Six Minute Walk Test (6MWT) is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

A total of 157 subjects were enrolled in the COAPT CAS study. 6MWT data was available for 98 subjects at 30 days..

Arm/Group Title	MitraClip System
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System
Measure Participants	98
Mean (Standard Deviation) [meters]	232.59 (145.67)

11. Secondary Outcome

Title	Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis)
Description	COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019. Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

12. Secondary Outcome

Title	Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis)
Description	MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Echocardiogram data was available for 120 subjects at 30 days.

Arm/Group Title	MitraClip System
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System
Measure Participants	120
None or Trace/Trivial	8 2.6%
Mild (1+)	68 22.5%
Moderate (2+)	35 11.6%
Moderate - Severe (3+)	6 2%
Severe (4+)	3 1%

13. Secondary Outcome

Title	Major and/or Life Threatening Bleeding (COAPT CAS Study Analysis)
Description	COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019. Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

14. Secondary Outcome

Title	Major and/or Life Threatening Bleeding (COAPT CAS Study Analysis)
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System
Measure Participants	157
Count of Participants [Participants]	1 0.3%

15. Secondary Outcome

Title	Major Vascular Complications (COAPT CAS Study Analysis)
Description	COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019. Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

16. Secondary Outcome

Title	Major Vascular Complications (COAPT CAS Study Analysis)
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System
Measure Participants	157
Count of Participants [Participants]	0 0%

17. Secondary Outcome

Title	Renal Complication With Requirement for Dialysis (COAPT CAS Study Analysis)
Description	COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019. Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

18. Secondary Outcome

Title	Renal Complication With Requirement for Dialysis (COAPT CAS Study Analysis)
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System
Measure Participants	157
Count of Participants [Participants]	2 0.7%

19. Secondary Outcome

Title	Transient Ischemic Attack (TIA) (COAPT CAS Study Analysis)
Description	COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019. Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

20. Secondary Outcome

Title	Transient Ischemic Attack (TIA) (COAPT CAS Study Analysis)
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System
Measure Participants	157
Count of Participants [Participants]	0 0%

21. Secondary Outcome

Title	Stroke (COAPT CAS Study Analysis)
Description	COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019. Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

22. Secondary Outcome

Title	Stroke (COAPT CAS Study Analysis)
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System
Measure Participants	157
Count of Participants [Participants]	1 0.3%

23. Secondary Outcome

Title	Myocardial Infarction (MI) (COAPT CAS Study Analysis)
Description	COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019. Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

24. Secondary Outcome

Title	Myocardial Infarction (MI) (COAPT CAS Study Analysis)
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System
Measure Participants	157
Count of Participants [Participants]	0 0%

25. Secondary Outcome

Title	Death and Primary Cause of Death (COAPT CAS Study Analysis)
Description	COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019. Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

26. Secondary Outcome

Title	Death and Primary Cause of Death (COAPT CAS Study Analysis)
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System
Measure Participants	157
Cardiac	2 0.7%
Neurologic	0 0%
Renal	0 0%
Vascular	0 0%
Infection	0 0%
Valvular	0 0%
Unknown	1 0.3%
Other	0 0%

27. Secondary Outcome

Title	Percentage of Patients Free From the Composite of All-cause Death, Stroke, MI, or Non-elective Cardiovascular Surgery for Device Related Complications in the Device Group
Description	The percentage of patients free from the composite endpoint as described above.
Time Frame	30 days post-procedure in the Device group

Outcome Measure Data

Analysis Population Description

All device subjects

Arm/Group Title	MitraClip System
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System
Measure Participants	302
Number (95% Confidence Interval) [Percentage of Participants]	96.9 32.1%

28. Secondary Outcome

Title	Number of Deaths at 12 Months (All Cause Mortality)
Description	Death from any cause mortality at 12months.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All device and control group subjects were included in the analysis.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
Number [participants]	57 18.9%	70 22.4%

29. Secondary Outcome

Title	Number of Participants With Mitral Regurgitation Severity Grade of 2+ or Lower at 12 Months
Description	MR severity grade of 2+ or lower at 12 months MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Echocardiography data was available for 210 subjects in Device group and 175 subjects in Control group

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	210	175
Count of Participants [Participants]	199 65.9%	82 26.3%

30. Secondary Outcome

Title	Change in Distance Walked on the 6 Minute Walk Test (6MWT Distance or 6MWD)
Description	The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.
Time Frame	12 months over baseline

Outcome Measure Data

Analysis Population Description

Analysis population includes subjects still active and with paired available compared to baseline.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	230	237
Mean (Standard Deviation) [meters]	-2.17 (9.12)	-60.2 (8.99)

31. Secondary Outcome

Title	Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description	Paired data looking at difference between the baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and 12 month KCCQ score. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Time Frame	12 months over baseline

Outcome Measure Data

Analysis Population Description

Analysis population includes subjects still active and with paired available compared to baseline.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	237	228
Mean (Standard Deviation) [KCCQ Score on a points scale]	12.5 (1.8)	-3.6 (1.9)

32. Secondary Outcome

Title	Change in Left Ventricular End Diastolic Volume (LVEDV)
Description	Paired data comparing the Change in LVEDV at baseline vs 12 months
Time Frame	12 months over baseline

Outcome Measure Data

Analysis Population Description

Analysis population includes subjects with echocardiography paired data available

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	175	174
Mean (Standard Deviation) [mL]	-3.71 (5.08)	17.06 (5.10)

33. Secondary Outcome

Title	Number of Participants With New York Heart Association (NYHA) Functional Class I/II
Description	NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA CLASS) Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Analysis population includes subjects with available NYHA class data at 12 months

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	237	232
Count of Participants [Participants]	171 56.6%	115 36.9%

34. Secondary Outcome

Title	Recurrent Hospitalizations - All Cause
Description	Number of Recurrent Hospitalizations for any cause within 24 months.
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

All randomized subjects in Device and Control Group

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
Number [Number of Events]	474	610

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MitraClip System, Control Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.02
	Comments
	Method	Joint Fraility Model
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.76
	Confidence Interval	(2-Sided) 95%; 0.60 to 0.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

35. Secondary Outcome

Title	Death or HF Hospitalization Within 24 Months (Finkelstein-Schoenfeld Analysis of All-Cause Death or Recurrent HF Hospitalization Through 24 Months)
Description	The win ratio is a useful method for providing an estimate of the treatment effect when composite endpoints are analyzed as the analysis accounts for clinical significance of the outcomes of interest. For example, in the composite of death and recurrent HF hospitalizations through 24 months, subjects in the Device and Control groups were formed into matched pairs, where each pair of subjects was classified into 1 of 5 outcomes scenarios: A. Death in Device group first B. Death in Control group first C. More HF hospitalizations in the Device group (or in the case of a tie, the first HF hospitalization in the Device group occurs first) D. More HF hospitalization in the Control group (or in the case of tie, the first HF hospitalization in the Control group occurs first) E. None of the above In this way, the number of "Winners" in the Device group was NW = NB + ND while the number of "Losers" in the Device group was NL = NA + NC. The "Win Ratio" was then calculated as NW/NL.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Randomized Group
Arm/Group Description	Randomized group contains both Device and Control Group
Measure Participants	614
Number (95% Confidence Interval) [Win Ratio]	1.61

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MitraClip System
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Finkelstein-Schoenfeld Analysis
	Comments
Method of Estimation	Estimation Parameter	Win Ratio
	Estimated Value	1.61
	Confidence Interval	(2-Sided) 95%; 1.29 to 2.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

36. Secondary Outcome

Title	Death and Primary Cause of Death (COAPT CAS Study Analysis)
Description	The COAPT study is still on-going. Only the Primary and major secondary endpoints have been entered. Rest of the results will be entered when the study ends in July 2024.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

37. Secondary Outcome

Title	Death and Primary Cause of Death (COAPT CAS Study Analysis)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

38. Secondary Outcome

Title	Death and Primary Cause of Death (COAPT CAS Study Analysis)
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

39. Secondary Outcome

Title	Death and Primary Cause of Death (COAPT CAS Study Analysis)
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

40. Secondary Outcome

Title	Myocardial Infarction (MI) (COAPT CAS Study Analysis)
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

41. Secondary Outcome

Title	Myocardial Infarction (MI) (COAPT CAS Study Analysis)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

42. Secondary Outcome

Title	Myocardial Infarction (MI) (COAPT CAS Study Analysis)
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

43. Secondary Outcome

Title	Myocardial Infarction (MI) (COAPT CAS Study Analysis)
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

44. Secondary Outcome

Title	Stroke (COAPT CAS Study Analysis)
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

45. Secondary Outcome

Title	Stroke (COAPT CAS Study Analysis)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

46. Secondary Outcome

Title	Stroke (COAPT CAS Study Analysis)
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

47. Secondary Outcome

Title	Stroke (COAPT CAS Study Analysis)
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

48. Secondary Outcome

Title	Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

49. Secondary Outcome

Title	Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

50. Secondary Outcome

Title	Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

51. Secondary Outcome

Title	Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

52. Secondary Outcome

Title	Kaplan-Meier Freedom From All-cause Mortality
Description	Death from any cause within 24 months - no of events
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Total number of subjects randomized in the Device and Control group

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
Number [no of events]	83	125

53. Other Pre-specified Outcome

Title	Device or Procedure-Related Adverse Events
Description	Device or procedure-related adverse events are defined as adverse events that are adjudicated by the Clinical Events Committee as possibly, probably or definitely device and/or procedure-related, regardless of the temporal relationship to the MitraClip procedure. Device or procedure-related adverse events will be broken down into those that occur within 30 days of the procedure and those that occur after 30 days of the procedure. Examples of device-related adverse events are: myocardial perforation, Single Leaflet Device Attachment, embolization of the MitraClip device or MitraClip System components, iatrogenic atrial septal defect, mitral valve stenosis, need for mitral valve replacement instead of repair due at least in part to the MitraClip procedure or the presence of the MitraClip device.
Time Frame	Within and after 30 days of the procedure

Outcome Measure Data

Analysis Population Description

All available data has been reported.

Arm/Group Title	MitraClip System
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System
Measure Participants	302
Occurred within 30 days	17 5.6%
Occurred between 31 days and 365 days	4 1.3%

54. Other Pre-specified Outcome

Title	Implant Rate
Description	Defined as the rate of successful delivery and deployment of the MitraClip device(s) with echocardiographic evidence of leaflet approximation and retrieval of the delivery catheter
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

Subjects randomized to the device arm

Arm/Group Title	MitraClip System
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System
Measure Participants	302
Count of Participants [Participants]	287 95%

55. Other Pre-specified Outcome

Title	Device Procedure Time
Description	Defined as the time elapsed from the start of the transseptal procedure to the time the Steerable Guide Catheter is removed
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

Device procedure time was not available for all implanted subjects. Data was available for 282 subjects from 302 randomized subjects in device arm.

Arm/Group Title	MitraClip System
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System
Measure Participants	282
Mean (Standard Deviation) [minutes]	118.9 (63.5)

56. Other Pre-specified Outcome

Title	Total Procedure Time
Description	Defined as the time elapsed from the first of any of the following: intravascular catheter placement, anesthesia or sedation, or transesophageal echocardiogram (TEE), to the removal of the last catheter and TEE
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

Total procedure time was available for 293 subjects from the 302 subjects randomized to device arm.

Arm/Group Title	MitraClip System
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System
Measure Participants	293
Mean (Standard Deviation) [minutes]	162.9 (118.1)

57. Other Pre-specified Outcome

Title	Device Time
Description	Defined as the time the Steerable Guide Catheter is placed in the intra-atrial septum until the time the MitraClip Delivery System (CDS) is retracted into the Steerable Guide Catheter
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

Device time available for all 287 subjects implanted with MitraClip.

Arm/Group Title	MitraClip System
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System
Measure Participants	287
Mean (Standard Deviation) [minutes]	82.7 (80.8)

58. Other Pre-specified Outcome

Title	Fluoroscopy Duration
Description	Defined as the duration of exposure to fluoroscopy during the MitraClip procedure
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

Fluoroscopy duration for all available subjects with MitraClip device

Arm/Group Title	MitraClip System
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System
Measure Participants	284
Mean (Standard Deviation) [minutes]	33.9 (23.2)

59. Other Pre-specified Outcome

Title	MR Severity Grade
Description	MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

echocardiogram data was available for 302 subjects in the device arm and 311 subjects in the control arm.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	311
MR 3+	148 49%	172 55.1%
MR 4+	154 51%	139 44.6%

60. Other Pre-specified Outcome

Title	MR Severity Grade
Description	MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2
Time Frame	At discharge (or 30 days if discharge echocardiogram is not available)

Outcome Measure Data

Analysis Population Description

Echocardiogram data was available for 286 subjects in the device arm and 257 subjects in the control arm.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	286	257
MR None or 1+	230 76.2%	21 6.7%
MR 2+	39 12.9%	67 21.5%
MR 3+	13 4.3%	96 30.8%
MR 4+	4 1.3%	73 23.4%

61. Other Pre-specified Outcome

Title	MR Severity Grade
Description	MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Echocardiogram data was available for only 240 subjects in the device group and 218 subjects in the control group

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	240	218
MR none or 1+	160 53%	20 6.4%
MR 2+	65 21.5%	63 20.2%
MR 3+	11 3.6%	92 29.5%
MR 4+	4 1.3%	43 13.8%

62. Other Pre-specified Outcome

Title	MR Severity Grade
Description	MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Echocardiogram data was available for 210 subjects in the device arm and 175 subjects in the control arm.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	210	175
MR None or 1+	145 48%	20 6.4%
MR 2+	54 17.9%	62 19.9%
MR 3+	9 3%	60 19.2%
MR 4+	2 0.7%	33 10.6%

63. Other Pre-specified Outcome

Title	MR Severity Grade
Description	MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Echocardiogram data was available for 162 subjects in the device arm and 124 subjects in the control arm.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	162	124
MR None or 1+	127 42.1%	23 7.4%
MR 2+	34 11.3%	34 10.9%
MR 3+	0 0%	43 13.8%
MR 4+	1 0.3%	24 7.7%

64. Other Pre-specified Outcome

Title	MR Severity Grade
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

65. Other Pre-specified Outcome

Title	MR Severity Grade
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

66. Other Pre-specified Outcome

Title	MR Severity Grade
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

67. Other Pre-specified Outcome

Title	Effective Regurgitant Orifice Area
Description	Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Echocardiogram data was available for the 289 subjects in the device arm and 302 subjects in the control arm.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	289	302
Mean (Standard Deviation) [cm^2]	0.41 (0.15)	0.40 (0.15)

68. Other Pre-specified Outcome

Title	Effective Regurgitant Orifice Area
Description	Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity
Time Frame	At discharge (or 30 days if discharge echocardiogram is not available)

Outcome Measure Data

Analysis Population Description

Echocardiogram data was available for 75 subjects in the device arm and 73 subjects in the control arm.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	75	73
Mean (Standard Deviation) [cm^2]	0.14 (0.08)	0.23 (0.16)

69. Other Pre-specified Outcome

Title	Effective Regurgitant Orifice Area
Description	Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Echocardiogram data was available for 39 subjects in the device arm and 54 subjects in the control arm

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	39	54
Mean (Standard Deviation) [cm^2]	0.22 (0.19)	0.25 (0.14)

70. Other Pre-specified Outcome

Title	Effective Regurgitant Orifice Area
Description	Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Echocardiogram data was available for 39 subjects in the device arm and 46 subjects in the control arm

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	39	46
Mean (Standard Deviation) [cm^2]	0.18 (0.12)	0.26 (0.19)

71. Other Pre-specified Outcome

Title	Effective Regurgitant Orifice Area
Description	Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Echocardiogram data was available for 18 subjects in the device arm and 24 subjects in the control arm

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	18	24
Mean (Standard Deviation) [cm^2]	0.15 (0.09)	0.26 (0.12)

72. Other Pre-specified Outcome

Title	Effective Regurgitant Orifice Area
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

73. Other Pre-specified Outcome

Title	Effective Regurgitant Orifice Area
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

74. Other Pre-specified Outcome

Title	Effective Regurgitant Orifice Area
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

75. Other Pre-specified Outcome

Title	Regurgitant Volume
Description	Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Echocardiogram data was available for 124 subjects in the device arm and 136 subjects in the control arm.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	124	136
Mean (Standard Deviation) [ml/beat]	28.80 (16.99)	25.01 (15.31)

76. Other Pre-specified Outcome

Title	Regurgitant Volume
Description	Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole.
Time Frame	At discharge (or 30 days if discharge echocardiogram is not available)

Outcome Measure Data

Analysis Population Description

Echocardiogram data was available for 85 subjects in device arm and 70 subjects in control arm

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	85	70
Mean (Standard Deviation) [ml/beat]	20.04 (11.86)	25.97 (15.68)

77. Other Pre-specified Outcome

Title	Regurgitant Volume
Description	Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Echocardiogram data was available for 45 subjects in the device arm and 54 subjects in the control arm.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	45	54
Mean (Standard Deviation) [ml/beat]	23.60 (16.00)	32.59 (15.82)

78. Other Pre-specified Outcome

Title	Regurgitant Volume
Description	Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Echocardiogram data was available for 33 subjects in the device arm and 45 subjects in the control arm.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	33	45
Mean (Standard Deviation) [ml/beat]	21.61 (12.12)	27.76 (14.35)

79. Other Pre-specified Outcome

Title	Regurgitant Volume
Description	Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Echocardiogram data was available for 20 subjects in the device arm and 27 subjects in the control arm

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	20	27
Mean (Standard Deviation) [ml/beat]	21.10 (11.50)	33.37 (16.20)

80. Other Pre-specified Outcome

Title	Regurgitant Volume
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

81. Other Pre-specified Outcome

Title	Regurgitant Volume
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

82. Other Pre-specified Outcome

Title	Regurgitant Volume
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

83. Other Pre-specified Outcome

Title	Regurgitant Fraction
Description	Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Echocardiogram data was available for 123 subjects in the device group and 136 subjects in the control group.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	123	136
Mean (Standard Deviation) [percentage]	38.24 (13.81)	34.81 (14.94)

84. Other Pre-specified Outcome

Title	Regurgitant Fraction
Description	Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency.
Time Frame	At discharge (or 30 days if discharge echocardiogram is not available)

Outcome Measure Data

Analysis Population Description

Echocardiogram data was available for 85 subjects in the device arm and 70 subjects in the control arm.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	85	70
Mean (Standard Deviation) [percentage]	31.00 (14.53)	35.29 (15.32)

85. Other Pre-specified Outcome

Title	Regurgitant Fraction
Description	Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Echocardiogram data was available for 45 subjects in the device arm and 54 subjects in the control arm

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	45	54
Mean (Standard Deviation) [percentage]	34.14 (15.89)	42.20 (14.49)

86. Other Pre-specified Outcome

Title	Regurgitant Fraction
Description	Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Echocardiogram data was available for 33 subjects in the device arm and 45 subjects in the control arm.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	33	45
Mean (Standard Deviation) [percentage]	32.15 (13.06)	37.80 (15.49)

87. Other Pre-specified Outcome

Title	Regurgitant Fraction
Description	Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Echocardiogram data is available for 20 subjects in the device arm and 27 subjects in the control arm.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	20	27
Mean (Standard Deviation) [percentage]	33.50 (14.43)	42.23 (15.03)

88. Other Pre-specified Outcome

Title	Regurgitant Fraction
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

89. Other Pre-specified Outcome

Title	Regurgitant Fraction
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

90. Other Pre-specified Outcome

Title	Regurgitant Fraction
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

91. Other Pre-specified Outcome

Title	Left Ventricle End Diastolic Volume (LVEDV)
Description	Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All available echocardiogram data used for analysis.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	281	294
Mean (Standard Deviation) [mL]	194.4 (69.2)	191.0 (72.9)

92. Other Pre-specified Outcome

Title	Left Ventricle End Diastolic Volume (LVEDV)
Description	Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.
Time Frame	At discharge (or 30 days if discharge echocardiogram is not available)

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been presented.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	259	223
Mean (Standard Deviation) [mL]	176.0 (64.6)	179.1 (68.4)

93. Other Pre-specified Outcome

Title	Left Ventricle End Diastolic Volume (LVEDV)
Description	Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been presented.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	200	171
Mean (Standard Deviation) [mL]	181.4 (65.1)	182.6 (72.4)

94. Other Pre-specified Outcome

Title	Left Ventricle End Diastolic Volume (LVEDV)
Description	Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been presented.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	168	146
Mean (Standard Deviation) [mL]	179.4 (66.2)	176.3 (65.1)

95. Other Pre-specified Outcome

Title	Left Ventricle End Diastolic Volume (LVEDV)
Description	Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been presented

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	116	92
Mean (Standard Deviation) [mL]	176.0 (60.8)	185.7 (73.8)

96. Other Pre-specified Outcome

Title	Left Ventricle End Diastolic Volume (LVEDV)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

97. Other Pre-specified Outcome

Title	Left Ventricle End Diastolic Volume (LVEDV)
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

98. Other Pre-specified Outcome

Title	Left Ventricle End Diastolic Volume (LVEDV)
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

99. Other Pre-specified Outcome

Title	Left Ventricular End Systolic Volume (LVESV)
Description	Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been presented.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	281	294
Mean (Standard Deviation) [mL]	135.5 (56.1)	134.3 (60.3)

100. Other Pre-specified Outcome

Title	Left Ventricular End Systolic Volume (LVESV)
Description	Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle.
Time Frame	At discharge (or 30 days if discharge echocardiogram is not available)

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been presented.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	258	223
Mean (Standard Deviation) [mL]	129.3 (56.5)	125.7 (57.1)

101. Other Pre-specified Outcome

Title	Left Ventricular End Systolic Volume (LVESV)
Description	Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been presented.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	200	171
Mean (Standard Deviation) [mL]	133.1 (59.2)	129.1 (59.2)

102. Other Pre-specified Outcome

Title	Left Ventricular End Systolic Volume (LVESV)
Description	Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been presented.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	168	146
Mean (Standard Deviation) [mL]	133.0 (60.9)	125.9 (54.8)

103. Other Pre-specified Outcome

Title	Left Ventricular End Systolic Volume (LVESV)
Description	Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been presented.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	116	92
Mean (Standard Deviation) [mL]	128.2 (52.9)	133.2 (65.1)

104. Other Pre-specified Outcome

Title	Left Ventricular End Systolic Volume (LVESV)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

105. Other Pre-specified Outcome

Title	Left Ventricular End Systolic Volume (LVESV)
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

106. Other Pre-specified Outcome

Title	Left Ventricular End Systolic Volume (LVESV)
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

107. Other Pre-specified Outcome

Title	Left Ventricular End Diastolic Dimension (LVEDD)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been presented.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	301	307
Mean (Standard Deviation) [cm]	6.17 (0.73)	6.19 (0.75)

108. Other Pre-specified Outcome

Title	Left Ventricular End Diastolic Dimension (LVEDD)
Time Frame	At discharge (or 30 days if discharge echocardiogram is not available)

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been presented.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	286	249
Mean (Standard Deviation) [cm]	6.10 (0.75)	7.41 (19.58)

109. Other Pre-specified Outcome

Title	Left Ventricular End Diastolic Dimension (LVEDD)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been presented.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	231	210
Mean (Standard Deviation) [cm]	6.12 (0.77)	6.15 (0.81)

110. Other Pre-specified Outcome

Title	Left Ventricular End Diastolic Dimension (LVEDD)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been presented.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	198	174
Mean (Standard Deviation) [cm]	6.08 (0.77)	6.10 (0.83)

111. Other Pre-specified Outcome

Title	Left Ventricular End Diastolic Dimension (LVEDD)
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been presented.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	152	124
Mean (Standard Deviation) [cm]	6.07 (0.92)	6.19 (0.88)

112. Other Pre-specified Outcome

Title	Left Ventricular End Diastolic Dimension (LVEDD)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

113. Other Pre-specified Outcome

Title	Left Ventricular End Diastolic Dimension (LVEDD)
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

114. Other Pre-specified Outcome

Title	Left Ventricular End Diastolic Dimension (LVEDD)
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

115. Other Pre-specified Outcome

Title	Left Ventricular End Systolic Dimension (LVESD)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	301	306
Mean (Standard Deviation) [cm]	5.28 (0.86)	5.30 (0.89)

116. Other Pre-specified Outcome

Title	Left Ventricular End Systolic Dimension (LVESD)
Time Frame	At discharge (or 30 days if discharge echocardiogram is not available)

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	286	248
Mean (Standard Deviation) [cm]	5.31 (0.89)	6.12 (12.64)

117. Other Pre-specified Outcome

Title	Left Ventricular End Systolic Dimension (LVESD)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	231	208
Mean (Standard Deviation) [cm]	5.34 (0.91)	5.28 (0.96)

118. Other Pre-specified Outcome

Title	Left Ventricular End Systolic Dimension (LVESD)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	197	173
Mean (Standard Deviation) [cm]	5.26 (0.95)	5.25 (0.99)

119. Other Pre-specified Outcome

Title	Left Ventricular End Systolic Dimension (LVESD)
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	151	121
Mean (Standard Deviation) [cm]	5.24 (1.08)	5.27 (1.02)

120. Other Pre-specified Outcome

Title	Left Ventricular End Systolic Dimension (LVESD)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

121. Other Pre-specified Outcome

Title	Left Ventricular End Systolic Dimension (LVESD)
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

122. Other Pre-specified Outcome

Title	Left Ventricular End Systolic Dimension (LVESD)
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

123. Other Pre-specified Outcome

Title	Left Ventricular Ejection Fraction (LVEF)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	281	294
Mean (Standard Deviation) [percentage]	31.32 (9.07)	31.30 (9.58)

124. Other Pre-specified Outcome

Title	Left Ventricular Ejection Fraction (LVEF)
Time Frame	At discharge (or 30 days if discharge echocardiogram is not available)

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	259	223
Mean (Standard Deviation) [percentage]	27.88 (8.84)	31.11 (10.45)

125. Other Pre-specified Outcome

Title	Left Ventricular Ejection Fraction (LVEF)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	200	171
Mean (Standard Deviation) [percentage]	28.38 (10.45)	30.44 (10.15)

126. Other Pre-specified Outcome

Title	Left Ventricular Ejection Fraction (LVEF)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	168	146
Mean (Standard Deviation) [percentage]	27.74 (11.31)	29.72 (10.06)

127. Other Pre-specified Outcome

Title	Left Ventricular Ejection Fraction (LVEF)
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	116	92
Mean (Standard Deviation) [percentage]	28.2 (9.2)	30.64 (12.27)

128. Other Pre-specified Outcome

Title	Left Ventricular Ejection Fraction (LVEF)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

129. Other Pre-specified Outcome

Title	Left Ventricular Ejection Fraction (LVEF)
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

130. Other Pre-specified Outcome

Title	Left Ventricular Ejection Fraction (LVEF)
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

131. Other Pre-specified Outcome

Title	Right Ventricular Systolic Pressure (RVSP)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	253	275
Mean (Standard Deviation) [mmHg]	43.95 (13.44)	44.56 (13.96)

132. Other Pre-specified Outcome

Title	Right Ventricular Systolic Pressure (RVSP)
Time Frame	At discharge (or 30 days if discharge echocardiogram is not available)

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	257	239
Mean (Standard Deviation) [mmHg]	41.41 (11.63)	43.81 (14.24)

133. Other Pre-specified Outcome

Title	Right Ventricular Systolic Pressure (RVSP)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	196	188
Mean (Standard Deviation) [mmHg]	40.96 (13.06)	42.21 (14.19)

134. Other Pre-specified Outcome

Title	Right Ventricular Systolic Pressure (RVSP)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	170	144
Mean (Standard Deviation) [mmHg]	38.63 (13.00)	39.31 (13.24)

135. Other Pre-specified Outcome

Title	Right Ventricular Systolic Pressure (RVSP)
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	123	98
Mean (Standard Deviation) [mmHg]	39.67 (12.94)	40.38 (14.95)

136. Other Pre-specified Outcome

Title	Right Ventricular Systolic Pressure (RVSP)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

137. Other Pre-specified Outcome

Title	Right Ventricular Systolic Pressure (RVSP)
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

138. Other Pre-specified Outcome

Title	Right Ventricular Systolic Pressure (RVSP)
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

139. Other Pre-specified Outcome

Title	Mitral Valve Area
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	284	302
Mean (Standard Deviation) [cm^2]	5.17 (1.26)	5.16 (1.16)

140. Other Pre-specified Outcome

Title	Mitral Valve Area
Time Frame	At discharge (or 30 days if discharge echocardiogram is not available)

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	174	235
Mean (Standard Deviation) [cm^2]	2.68 (0.92)	4.81 (1.00)

141. Other Pre-specified Outcome

Title	Mitral Valve Area
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	107	189
Mean (Standard Deviation) [cm^2]	2.84 (1.10)	4.94 (1.00)

142. Other Pre-specified Outcome

Title	Mitral Valve Area
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	106	142
Mean (Standard Deviation) [cm^2]	2.67 (0.86)	4.88 (0.95)

143. Other Pre-specified Outcome

Title	Mitral Valve Area
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	65	92
Mean (Standard Deviation) [cm^2]	2.85 (1.01)	5.00 (1.13)

144. Other Pre-specified Outcome

Title	Mitral Valve Area
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

145. Other Pre-specified Outcome

Title	Mitral Valve Area
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

146. Other Pre-specified Outcome

Title	Mitral Valve Area
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

147. Other Pre-specified Outcome

Title	Mean Mitral Valve Gradient
Description	The normal area of the mitral valve orifice is about 4-6 cm2 when the mitral valve area goes below 2 cm2, the valve causes an impediment to the flow of blood into the left ventricle, creating a pressure gradient (mitral valve gradient) across the mitral valve. This gradient may increase by the rise in heart rate or cardiac output.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	208	234
Mean (Standard Deviation) [mmHg]	2.46 (1.05)	2.28 (0.97)

148. Other Pre-specified Outcome

Title	Mean Mitral Valve Gradient
Description	The normal area of the mitral valve orifice is about 4-6 cm2 when the mitral valve area goes below 2 cm2, the valve causes an impediment to the flow of blood into the left ventricle, creating a pressure gradient (mitral valve gradient) across the mitral valve. This gradient may increase by the rise in heart rate or cardiac output.
Time Frame	At discharge (or 30 days if discharge echocardiogram is not available)

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	282	184
Mean (Standard Deviation) [mmHg]	4.10 (2.18)	2.28 (1.28)

149. Other Pre-specified Outcome

Title	Mean Mitral Valve Gradient
Description	The normal area of the mitral valve orifice is about 4-6 cm2 when the mitral valve area goes below 2 cm2, the valve causes an impediment to the flow of blood into the left ventricle, creating a pressure gradient (mitral valve gradient) across the mitral valve. This gradient may increase by the rise in heart rate or cardiac output.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	222	160
Mean (Standard Deviation) [mmHg]	4.00 (1.98)	2.28 (1.28)

150. Other Pre-specified Outcome

Title	Mean Mitral Valve Gradient
Description	The normal area of the mitral valve orifice is about 4-6 cm2 when the mitral valve area goes below 2 cm2, the valve causes an impediment to the flow of blood into the left ventricle, creating a pressure gradient (mitral valve gradient) across the mitral valve. This gradient may increase by the rise in heart rate or cardiac output.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	197	138
Mean (Standard Deviation) [mmHg]	3.88 (2.17)	2.15 (1.30)

151. Other Pre-specified Outcome

Title	Mean Mitral Valve Gradient
Description	The normal area of the mitral valve orifice is about 4-6 cm2 when the mitral valve area goes below 2 cm2, the valve causes an impediment to the flow of blood into the left ventricle, creating a pressure gradient (mitral valve gradient) across the mitral valve. This gradient may increase by the rise in heart rate or cardiac output.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	147	94
Mean (Standard Deviation) [mmHg]	3.73 (1.77)	2.27 (1.73)

152. Other Pre-specified Outcome

Title	Mean Mitral Valve Gradient
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

153. Other Pre-specified Outcome

Title	Mean Mitral Valve Gradient
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

154. Other Pre-specified Outcome

Title	Mean Mitral Valve Gradient
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

155. Other Pre-specified Outcome

Title	Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	300	310
Present	1 0.3%	1 0.3%
Absent	299 99%	309 99%

156. Other Pre-specified Outcome

Title	Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Time Frame	At discharge (or 30 days if discharge echocardiogram is not available)

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	289	258
Present	1 0.3%	1 0.3%
Absent	288 95.4%	257 82.4%

157. Other Pre-specified Outcome

Title	Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	239	219
Present	0 0%	1 0.3%
Absent	239 79.1%	218 69.9%

158. Other Pre-specified Outcome

Title	Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	210	177
Present	0 0%	0 0%
Absent	210 69.5%	177 56.7%

159. Other Pre-specified Outcome

Title	Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	159	124
Present	0 0%	0 0%
Absent	159 52.6%	124 39.7%

160. Other Pre-specified Outcome

Title	Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

161. Other Pre-specified Outcome

Title	Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

162. Other Pre-specified Outcome

Title	Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

163. Other Pre-specified Outcome

Title	Cardiac Output
Description	The amount of blood the heart pumps through the circulatory system in a minute.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	238	251
Mean (Standard Deviation) [Liters/minute]	3.61 (1.09)	3.49 (1.08)

164. Other Pre-specified Outcome

Title	Cardiac Output
Description	The amount of blood the heart pumps through the circulatory system in a minute.
Time Frame	At discharge (or 30 days if discharge echocardiogram is not available)

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	275	236
Mean (Standard Deviation) [Liters/minute]	3.79 (1.17)	3.61 (1.18)

165. Other Pre-specified Outcome

Title	Cardiac Output
Description	The amount of blood the heart pumps through the circulatory system in a minute.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	217	199
Mean (Standard Deviation) [Liters/minute]	3.53 (1.06)	3.53 (1.16)

166. Other Pre-specified Outcome

Title	Cardiac Output
Description	The amount of blood the heart pumps through the circulatory system in a minute.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	196	157
Mean (Standard Deviation) [Liters/minute]	3.59 (1.07)	3.66 (1.20)

167. Other Pre-specified Outcome

Title	Cardiac Output
Description	The amount of blood the heart pumps through the circulatory system in a minute.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	139	114
Mean (Standard Deviation) [Liters/minute]	3.44 (0.95)	3.39 (1.01)

168. Other Pre-specified Outcome

Title	Cardiac Output
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

169. Other Pre-specified Outcome

Title	Cardiac Output
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

170. Other Pre-specified Outcome

Title	Cardiac Output
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

171. Other Pre-specified Outcome

Title	Forward Stroke Volume
Description	Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	283	292
Mean (Standard Deviation) [mL]	50.47 (16.52)	50.72 (16.91)

172. Other Pre-specified Outcome

Title	Forward Stroke Volume
Description	Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume.
Time Frame	At discharge (or 30 days if discharge echocardiogram is not available)

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	278	243
Mean (Standard Deviation) [mL]	52.41 (17.06)	50.75 (17.69)

173. Other Pre-specified Outcome

Title	Forward Stroke Volume
Description	Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	222	207
Mean (Standard Deviation) [mL]	52.13 (16.60)	49.89 (16.80)

174. Other Pre-specified Outcome

Title	Forward Stroke Volume
Description	Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	200	165
Mean (Standard Deviation) [mL]	52.33 (16.46)	53.49 (17.73)

175. Other Pre-specified Outcome

Title	Forward Stroke Volume
Description	Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	142	116
Mean (Standard Deviation) [mL]	50.97 (15.73)	49.37 (15.71)

176. Other Pre-specified Outcome

Title	Forward Stroke Volume
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

177. Other Pre-specified Outcome

Title	Forward Stroke Volume
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

178. Other Pre-specified Outcome

Title	Forward Stroke Volume
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

179. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From the Components of the Primary Safety Composite
Description	Freedom from the components of the primary safety composite of device related complications including Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, or any device related complications requiring non-elective cardiovascular surgery at 12 months will be the primary measure of safety.
Time Frame	12 months in Device group

Outcome Measure Data

Analysis Population Description

All eligible subjects with MitraClip until the 365 day window.

Arm/Group Title	MitraClip System
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System
Measure Participants	237
Single Leaflet Device Attachment (SLDA)	99.3
Embolization	99.7
Left Ventricular Assist Device (LVAD)	98.8
Heart Transplant	99.2
Non-elective Cardiovascular surgery	99.7

180. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From the Components of the Primary Safety Composite
Description	Freedom from the components of the primary safety composite of device related complications including Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, or any device related complications requiring non-elective cardiovascular surgery at 12 months will be the primary measure of safety.
Time Frame	24 months in Device group

Outcome Measure Data

Analysis Population Description

All available subjects with data within the 2 year (731 days) window

Arm/Group Title	MitraClip System
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System
Measure Participants	175
Single Leaflet Device Attachment (SLDA)	99.3
Embolization	99.7
Left Ventricular Assist Device (LVAD)	97.4
Heart Transplant	98.7
Non-elective cardiovascular surgery	99.7

181. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From the Components of the Primary Safety Composite
Time Frame	3 years in Device group

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

182. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From the Components of the Primary Safety Composite
Time Frame	4 years in Device group

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

183. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From the Components of the Primary Safety Composite
Time Frame	5 years in Device group

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

184. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From the Primary Safety Composite
Description	Freedom from the primary safety composite of device related complications including Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, or any device related complications requiring non-elective cardiovascular surgery at 12 months will be the primary measure of safety.
Time Frame	24 months in Device group

Outcome Measure Data

Analysis Population Description

All available subjects with data within the 24 months (731 days) window.

Arm/Group Title	MitraClip System
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System
Measure Participants	169
Number [percentage]	94.8

185. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From the Primary Safety Composite
Time Frame	3 years in Device group

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

186. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From the Primary Safety Composite
Time Frame	4 years in Device group

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

187. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From the Primary Safety Composite
Time Frame	5 years in Device group

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

188. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From All-cause Mortality
Description	Kaplan-Meier survival rate for all cause mortality at 24 months
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	189	145
Number (95% Confidence Interval) [percentage]	71.8	57.0

189. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From All-cause Mortality
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

190. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From All-cause Mortality
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

191. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From All-cause Mortality
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

192. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From Cardiovascular Mortality
Description	Kaplan-Meier survival rate for Cardiovascular mortality.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	238	223
Number (95% Confidence Interval) [percentage]	86.2	80.7

193. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From Cardiovascular Mortality
Description	Kaplan-Meier survival rate for Cardiovascular mortality.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	189	144
Number (95% Confidence Interval) [percentage]	77.6	64.3

194. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From Cardiovascular Mortality
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

195. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From Cardiovascular Mortality
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

196. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From Cardiovascular Mortality
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

197. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From the First HF Related Hospitalization
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	196	156
Number (95% Confidence Interval) [Percentage]	75.1	60.4

198. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From the First HF Related Hospitalization
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	148	87
Number (95% Confidence Interval) [Percentage]	65.2	43.6

199. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From the First HF Related Hospitalization
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

200. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From the First HF Related Hospitalization
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

201. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From the First HF Related Hospitalization
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

202. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From the First Cardiovascular Hospitalization
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

203. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From the First Cardiovascular Hospitalization
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

204. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From the First Cardiovascular Hospitalization
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

205. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From the First Cardiovascular Hospitalization
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

206. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From the First Cardiovascular Hospitalization
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

207. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	196	156
Number (95% Confidence Interval) [Percentage]	66.5	53.8

208. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality
Description	Survival rate from the first HF related hospitalization or all-cause mortality.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

All available data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	148	87
Number (95% Confidence Interval) [percentage]	55.5	33.4

209. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

210. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

211. Other Pre-specified Outcome

Title	Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

212. Other Pre-specified Outcome

Title	NYHA Functional Class
Description	Measure Description: The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I: No symptoms and no limitation in ordinary physical activity Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity Class III: Marked limitation in activity due to symptoms Class IV: Severe limitations
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

NYHA Class data available for only 311 subjects

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
NYHA Class I	1 0.3%	0 0%
NYHA Class II	129 42.7%	110 35.3%
NYHA Class III	154 51%	168 53.8%
NYHA Class IV	18 6%	33 10.6%

213. Other Pre-specified Outcome

Title	NYHA Functional Class
Description	Measure Description: The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I: No symptoms and no limitation in ordinary physical activity Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity Class III: Marked limitation in activity due to symptoms Class IV: Severe limitations
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

All available data at 30 day follow-up

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	281	278
NYHA Class I	44 14.6%	14 4.5%
NYHA Class II	172 57%	120 38.5%
NYHA Class III	55 18.2%	117 37.5%
NYHA Class IV	10 3.3%	27 8.7%

214. Other Pre-specified Outcome

Title	NYHA Functional Class
Description	Measure Description: The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I: No symptoms and no limitation in ordinary physical activity Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity Class III: Marked limitation in activity due to symptoms Class IV: Severe limitations
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	253	238
NYHA Class I	51 16.9%	14 4.5%
NYHA Class II	139 46%	117 37.5%
NYHA Class III	56 18.5%	100 32.1%
NYHA Class IV	7 2.3%	7 2.2%

215. Other Pre-specified Outcome

Title	NYHA Functional Class
Description	Measure Description: The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I: No symptoms and no limitation in ordinary physical activity Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity Class III: Marked limitation in activity due to symptoms Class IV: Severe limitations
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	219	191
NYHA Class I	40 13.2%	18 5.8%
NYHA Class II	131 43.4%	97 31.1%
NYHA Class III	42 13.9%	65 20.8%
NYHA Class IV	6 2%	11 3.5%

216. Other Pre-specified Outcome

Title	NYHA Functional Class
Description	Measure Description: The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I: No symptoms and no limitation in ordinary physical activity Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity Class III: Marked limitation in activity due to symptoms Class IV: Severe limitations
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	176	143
NYHA Class I	31 10.3%	12 3.8%
NYHA Class II	91 30.1%	69 22.1%
NYHA Class III	44 14.6%	54 17.3%
NYHA Class IV	10 3.3%	8 2.6%

217. Other Pre-specified Outcome

Title	NYHA Functional Class
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

218. Other Pre-specified Outcome

Title	NYHA Functional Class
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

219. Other Pre-specified Outcome

Title	NYHA Functional Class
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

220. Other Pre-specified Outcome

Title	Six-Minute Walk Test Distance (6MWD)
Description	Six-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk test distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All available 6MWD has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	296	305
Mean (Standard Deviation) [meters]	249.6 (123.8)	234.5 (123.5)

221. Other Pre-specified Outcome

Title	6MWD
Description	Six-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk test distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	265	244
Mean (Standard Deviation) [meters]	290.1 (122.8)	243.0 (121.0)

222. Other Pre-specified Outcome

Title	6MWD
Description	Six-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk test distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All available 6MWD has been reported

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	237	203
Mean (Standard Deviation) [meters]	288.6 (128.0)	253.9 (126.2)

223. Other Pre-specified Outcome

Title	6MWD
Description	Six-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk test distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All available 6MWD has been reported

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	193	167
Mean (Standard Deviation) [meters]	308.4 (116.7)	269.7 (133.2)

224. Other Pre-specified Outcome

Title	6MWD
Description	Six-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk test distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

All available 6MWD has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	143	111
Mean (Standard Deviation) [meters]	294.2 (131.2)	273.8 (142.7)

225. Other Pre-specified Outcome

Title	Change in 6MWD From Baseline
Time Frame	Between baseline and 30 days

Outcome Measure Data

Analysis Population Description

All available data has been reported

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	260	243
Mean (Standard Deviation) [meters]	31.6 (106.4)	-0.9 (83.5)

226. Other Pre-specified Outcome

Title	Change in 6MWD From Baseline
Time Frame	Between baseline and 6 months

Outcome Measure Data

Analysis Population Description

All available data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	233	201
Mean (Standard Deviation) [meters]	25.9 (100.6)	0.66 (99.9)

227. Other Pre-specified Outcome

Title	Change in 6MWD From Baseline
Time Frame	Between baseline and 12 months

Outcome Measure Data

Analysis Population Description

All available data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	191	166
Mean (Standard Deviation) [meters]	33.9 (99.6)	5.5 (115.0)

228. Other Pre-specified Outcome

Title	Change in 6MWD From Baseline
Time Frame	Between baseline and 24 months

Outcome Measure Data

Analysis Population Description

All available data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	142	110
Mean (Standard Deviation) [meters]	12.5 (103.0)	1.1 (133.6)

229. Other Pre-specified Outcome

Title	Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores
Description	The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All available data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	309
Mean (Standard Deviation) [KCCQ score on a points scale]	53.2 (22.8)	51.6 (23.3)

230. Other Pre-specified Outcome

Title	KCCQ QoL Scores
Description	The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

All available data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	279	275
Mean (Standard Deviation) [KCCQ score on a points scale]	70.9 (21.1)	54.6 (24.7)

231. Other Pre-specified Outcome

Title	KCCQ QoL Scores
Description	The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All available data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	252	237
Mean (Standard Deviation) [KCCQ score on a points scale]	73.0 (21.3)	59.0 (24.7)

232. Other Pre-specified Outcome

Title	KCCQ QoL Scores
Description	The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All available data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	219	189
Mean (Standard Deviation) [KCCQ score on a points scale]	71.8 (22.2)	60.2 (24.5)

233. Other Pre-specified Outcome

Title	KCCQ QoL Scores
Description	The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

All available data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	175	138
Mean (Standard Deviation) [KCCQ score on a points scale]	71.3 (23.3)	58.9 (25.2)

234. Other Pre-specified Outcome

Title	Change in KCCQ QoL Scores From Baseline
Description	Paired data looking at difference between the baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and 30 days KCCQ score. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Time Frame	Between baseline and 30 days

Outcome Measure Data

Analysis Population Description

All available paired data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	279	272
Mean (Standard Deviation) [KCCQ score on a points scale]	16.9 (22.8)	2.1 (18.6)

235. Other Pre-specified Outcome

Title	Change in KCCQ QoL Scores From Baseline
Description	Paired data looking at difference between the baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and 6 months KCCQ score. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Time Frame	Between baseline and 6 months

Outcome Measure Data

Analysis Population Description

All available paired data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	252	236
Mean (Standard Deviation) [KCCQ score on a points scale]	18.5 (24.9)	5.3 (23.0)

236. Other Pre-specified Outcome

Title	Change in KCCQ QoL Scores From Baseline
Description	Paired data looking at difference between the baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and 12 months KCCQ score. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Time Frame	Between baseline and 12 months

Outcome Measure Data

Analysis Population Description

All available paired data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	219	188
Mean (Standard Deviation) [KCCQ score on a points scale]	17.0 (25.4)	5.1 (24.5)

237. Other Pre-specified Outcome

Title	Change in KCCQ QoL Scores From Baseline
Description	Paired data looking at difference between the baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and 24 months KCCQ score. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Time Frame	Between baseline and 24 months

Outcome Measure Data

Analysis Population Description

All available paired data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	175	138
Mean (Standard Deviation) [KCCQ score on a points scale]	17.4 (25.8)	3.4 (26.5)

238. Other Pre-specified Outcome

Title	SF-36 QoL Scores
Description	The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All available data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	299	308
SF-36 PCS	33.0 (9.1)	32.6 (10.0)
SF-36 MCS	46.7 (12.7)	13.0 (12.0)

239. Other Pre-specified Outcome

Title	SF-36 QoL Scores
Description	The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

All available data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	278	272
SF-36 PCS	39.2 (9.2)	33.6 (9.9)
SF-36 MCS	51.4 (11.5)	46.1 (13.4)

240. Other Pre-specified Outcome

Title	SF-36 QoL Scores
Description	The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All available data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	251	237
SF-36 PCS	39.0 (10.3)	34.2 (9.9)
SF-36 MCS	52.1 (10.3)	47.0 (12.9)

241. Other Pre-specified Outcome

Title	SF-36 QoL Scores
Description	The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All available data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	218	190
SF-36 PCS	38.7 (10.2)	34.6 (10.8)
SF-36 MCS	51.3 (10.8)	48.2 (13.8)

242. Other Pre-specified Outcome

Title	SF-36 QoL Scores
Description	The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

All available data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	174	137
SF-36 PCS	38.7 (10.4)	33.7 (9.8)
SF-36 MCS	50.6 (12.1)	47.2 (12.1)

243. Other Pre-specified Outcome

Title	Change in SF-36 QoL Scores From Baseline
Description	Paired data looking at difference between the baseline SF-36 and 30 days SF-36. The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).
Time Frame	Between baseline and 30 days

Outcome Measure Data

Analysis Population Description

All available data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	276	269
SF-36 PCS	6.0 (8.9)	0.6 (8.1)
SF_36 MCS	4.2 (12.2)	0.4 (12.0)

244. Other Pre-specified Outcome

Title	Change in SF-36 QoL Scores From Baseline
Description	Paired data looking at difference between the baseline SF-36 and 6 months days SF-36. The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).
Time Frame	Between baseline and 6 months

Outcome Measure Data

Analysis Population Description

All available data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	248	234
SF-36 PCS	5.5 (10.2)	1.0 (8.7)
SF-36 MCS	4.6 (12.2)	1.1 (10.7)

245. Other Pre-specified Outcome

Title	Change in SF-36 QoL Scores From Baseline
Description	Paired data looking at difference between the baseline SF-36 and 12 month SF-36. The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).
Time Frame	Between baseline and 12 months

Outcome Measure Data

Analysis Population Description

All available data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	215	187
SF-36 PCS	5.0 (10.4)	0.8 (9.8)
SF-36 MCS	4.3 (13.2)	1.9 (13.4)

246. Other Pre-specified Outcome

Title	Change in SF-36 QoL Scores From Baseline
Description	Paired data looking at difference between the baseline SF-36 and 24 months SF-36. The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).
Time Frame	Between baseline and 24 months

Outcome Measure Data

Analysis Population Description

All available data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	171	136
SF-36 PCS	5.0 (10.4)	0.7 (10.6)
SF-36 MCS	3.8 (14.2)	-0.3 (12.9)

247. Other Pre-specified Outcome

Title	Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group
Time Frame	Through 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

248. Other Pre-specified Outcome

Title	De Novo MitraClip Device Intervention in Control Group
Time Frame	Through 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

249. Other Pre-specified Outcome

Title	Responder Analysis for 6MWD
Description	Where responder is defined as alive and experiencing an improvement of 24 meters and 50 meters (difference in proportion of responders between Device and Control groups)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	191	166
Experiencing Improvement >= 24 meters	100 33.1%	66 21.2%
Experiencing Improvement >= 50 meters	75 24.8%	42 13.5%

250. Other Pre-specified Outcome

Title	Responder Analysis for 6MWD
Description	Where responder is defined as alive and experiencing an improvement of 24 meters and 50 meters (difference in proportion of responders between Device and Control groups)
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	106	72
Experiencing Improvement >= 24 meters	44 14.6%	34 10.9%
Experiencing Improvement >= 50 meters	34 11.3%	23 7.4%

251. Other Pre-specified Outcome

Title	Responder Analysis for LVEDV Index
Description	Where responder is defined as alive and experiencing an improvement of 12 ml/m2 (difference in proportion of responders between Device and Control groups)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	160	130
Count of Participants [Participants]	35 11.6%	32 10.3%

252. Other Pre-specified Outcome

Title	Responder Analysis for LVEDV Index
Description	Where responder is defined as alive and experiencing an improvement of 12 ml/m2 (difference in proportion of responders between Device and Control groups)
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	74	53
Count of Participants [Participants]	19 6.3%	16 5.1%

253. Other Pre-specified Outcome

Title	Responder Analysis for LVEDV Index
Description	Where responder is defined as alive and experiencing an improvement of 12 ml/m2 (difference in proportion of responders between Device and Control groups)
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

254. Other Pre-specified Outcome

Title	Responder Analysis for LVEDV Index
Description	Where responder is defined as alive and experiencing an improvement of 12 ml/m2 (difference in proportion of responders between Device and Control groups)
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

255. Other Pre-specified Outcome

Title	Responder Analysis for LVEDV Index
Description	Where responder is defined as alive and experiencing an improvement of 12 ml/m2 (difference in proportion of responders between Device and Control groups)
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

256. Other Pre-specified Outcome

Title	Responder Analysis for QoL (KCCQ)
Description	Where responder is defined as alive and experiencing an improvement of 5 points (difference in proportion of responders between Device and Control groups)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All available data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	219	188
Count of Participants [Participants]	151 50%	103 33%

257. Other Pre-specified Outcome

Title	Responder Analysis for QoL (KCCQ)
Description	Where responder is defined as alive and experiencing an improvement of 5 points (difference in proportion of responders between Device and Control groups)
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

All available data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	128	90
Count of Participants [Participants]	88 29.1%	46 14.7%

258. Other Pre-specified Outcome

Title	Each Subscale for QoL (KCCQ)
Description	difference in means between Device and Control groups for the Kansas City Cardiomyopathy Questionnaire (KCCQ) for the physical limitation and symptom stability scores.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

219 subjects from device group and 189 subjects from control group analyzed.

Arm/Group Title	Randomized Group
Arm/Group Description	Randomized group contains both Device and Control Group
Measure Participants	408
Number (95% Confidence Interval) [KCCQ score on a points scale]	9.90

259. Other Pre-specified Outcome

Title	Each Subscale for QoL (KCCQ)
Description	difference in means between Device and Control groups for the Kansas City Cardiomyopathy Questionnaire (KCCQ) for the physical limitation and symptom stability scores.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

128 subjects in the device group and 90 subjects in the control group were analyzed.

Arm/Group Title	Randomized Group
Arm/Group Description	Randomized group contains both Device and Control Group
Measure Participants	218
Number (95% Confidence Interval) [KCCQ score on a points scale]	8.01

260. Other Pre-specified Outcome

Title	Length of Index Hospitalization for MitraClip Procedure (Device Group)
Description	Length of stay in the hospital for the MitraClip Index procedure (device group)
Time Frame	Before MitraClip procedure on day 0

Outcome Measure Data

Analysis Population Description

Data was available for 293 subjects out of 302 subjects in the device group.

Arm/Group Title	MitraClip System
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System
Measure Participants	293
Mean (Standard Deviation) [Days]	2.5 (2.3)

261. Other Pre-specified Outcome

Title	Number of Hospitalizations and Reason for Hospitalization (i.e. Heart Failure, Cardiovascular, Non-cardiovascular)
Description	in each of the Device and Control groups
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
Heart Failure	70 23.2%	118 37.8%
Cardiovascular	52 17.2%	54 17.3%
Non-Cardiovascular	95 31.5%	97 31.1%

262. Other Pre-specified Outcome

Title	Number of Hospitalizations and Reason for Hospitalization (i.e. Heart Failure, Cardiovascular, Non-cardiovascular)
Description	in each of the Device and Control groups
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
Heart Failure	92 30.5%	151 48.4%
Cardiovascular	72 23.8%	72 23.1%
Non-Cardiovascular	124 41.1%	128 41%

263. Other Pre-specified Outcome

Title	Number of Days Alive and Out of Hospital
Description	difference in mean between Device and Control groups
Time Frame	From the time of randomization to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Randomized Group
Arm/Group Description	Randomized group contains both Device and Control Group
Measure Participants	614
Number (95% Confidence Interval) [Number of days]	11.8

264. Other Pre-specified Outcome

Title	Number of Days Alive and Out of Hospital
Description	difference in means between Device and Control groups
Time Frame	From the time of randomization to 24 months

Outcome Measure Data

Analysis Population Description

226 subjects from the device group and 226 subjects from the control group.

Arm/Group Title	Randomized Group
Arm/Group Description	Randomized group contains both Device and Control Group
Measure Participants	452
Number (95% Confidence Interval) [Number of Days]	66.5

265. Other Pre-specified Outcome

Title	Number of Days Alive and Out of Hospital
Description	difference in medians between Device and Control groups
Time Frame	From the time of randomization to 3 Years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

266. Other Pre-specified Outcome

Title	Number of Days Alive and Out of Hospital
Description	difference in medians between Device and Control groups
Time Frame	From the time of randomization to 4 Years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

267. Other Pre-specified Outcome

Title	Number of Days Alive and Out of Hospital
Description	difference in medians between Device and Control groups
Time Frame	From the time of randomization to 5 Years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

268. Other Pre-specified Outcome

Title	Number of Days Hospitalized From the "Treatment" Visit
Description	difference in means between Device and Control groups
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Randomized Group
Arm/Group Description	Randomized group contains both Device and Control Group
Measure Participants	614
Number (95% Confidence Interval) [Number of Days]	-0.4

269. Other Pre-specified Outcome

Title	Number of Days Hospitalized From the "Treatment" Visit
Description	difference in means between Device and Control groups
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

226 subjects in the device group and 226 subjects in the control group.

Arm/Group Title	Randomized Group
Arm/Group Description	Randomized group contains both Device and Control Group
Measure Participants	452
Number (95% Confidence Interval) [Number of Days]	-1.5

270. Other Pre-specified Outcome

Title	Number of Days Hospitalized From the "Treatment" Visit
Description	difference in medians between Device and Control groups
Time Frame	3 Years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

271. Other Pre-specified Outcome

Title	Number of Days Hospitalized From the "Treatment" Visit
Description	difference in medians between Device and Control groups
Time Frame	4 Years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

272. Other Pre-specified Outcome

Title	Number of Days Hospitalized From the "Treatment" Visit
Description	difference in medians between Device and Control groups
Time Frame	5 Years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

273. Other Pre-specified Outcome

Title	Proportion of Alive Time in Hospital
Description	summarized and compared between Device and Control groups
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
Mean (Standard Deviation) [Number of Days]	0.05 (0.10)	0.04 (0.09)

274. Other Pre-specified Outcome

Title	Proportion of Alive Time in Hospital
Description	summarized and compared between Device and Control groups
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	226	226
Mean (Standard Deviation) [Number of Days]	0.05 (0.10)	0.05 (0.07)

275. Other Pre-specified Outcome

Title	Proportion of Alive Time in Hospital
Description	summarized and compared between Device and Control groups
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

276. Other Pre-specified Outcome

Title	Proportion of Alive Time in Hospital
Description	summarized and compared between Device and Control groups
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

277. Other Pre-specified Outcome

Title	Proportion of Alive Time in Hospital
Description	summarized and compared between Device and Control groups
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

278. Other Pre-specified Outcome

Title	Proportion of Subjects Living in the Baseline Location
Description	Subjects living in the baseline location include : home, retirement home, nursing facility and other location.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	223	206
Count of Participants [Participants]	217 71.9%	198 63.5%

279. Other Pre-specified Outcome

Title	Proportion of Subjects Living in the Baseline Location
Description	Subjects living in the baseline location include : home, retirement home, nursing facility and other location.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	132	93
Count of Participants [Participants]	130 43%	87 27.9%

280. Other Pre-specified Outcome

Title	Proportion of Subjects Living in the Baseline Location
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

281. Other Pre-specified Outcome

Title	Proportion of Subjects Living in the Baseline Location
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

282. Other Pre-specified Outcome

Title	Proportion of Subjects Living in the Baseline Location
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

283. Other Pre-specified Outcome

Title	Mitral Valve Replacement Rates
Description	Subjects with mitral valve replacements in the Device and Control groups
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
Count of Participants [Participants]	1 0.3%	5 1.6%

284. Other Pre-specified Outcome

Title	Mitral Valve Replacement Rates
Description	Subjects with mitral valve replacements in the Device and Control groups
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
Count of Participants [Participants]	1 0.3%	5 1.6%

285. Other Pre-specified Outcome

Title	Mitral Valve Replacement Rates
Description	summarized and compared between Device and Control groups
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

286. Other Pre-specified Outcome

Title	Mitral Valve Replacement Rates
Description	summarized and compared between Device and Control groups
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

287. Other Pre-specified Outcome

Title	Mitral Valve Replacement Rates
Description	summarized and compared between Device and Control groups
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

288. Other Pre-specified Outcome

Title	New Onset of Permanent Atrial Fibrillation
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
Count of Participants [Participants]	14 4.6%	13 4.2%

289. Other Pre-specified Outcome

Title	New Onset of Permanent Atrial Fibrillation
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
Count of Participants [Participants]	18 6%	14 4.5%

290. Other Pre-specified Outcome

Title	New Onset of Permanent Atrial Fibrillation
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

291. Other Pre-specified Outcome

Title	New Onset of Permanent Atrial Fibrillation
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

292. Other Pre-specified Outcome

Title	New Onset of Permanent Atrial Fibrillation
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

293. Other Pre-specified Outcome

Title	Mitral Stenosis
Description	Defined as a mitral valve orifice area of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
Count of Participants [Participants]	18 6%	1 0.3%

294. Other Pre-specified Outcome

Title	Mitral Stenosis
Description	Defined as a mitral valve orifice area of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
Count of Participants [Participants]	24 7.9%	0 0%

295. Other Pre-specified Outcome

Title	Mitral Stenosis
Description	Defined as a mitral valve orifice area of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

296. Other Pre-specified Outcome

Title	Mitral Stenosis
Description	Defined as a mitral valve orifice area of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

297. Other Pre-specified Outcome

Title	Mitral Stenosis
Description	Defined as a mitral valve orifice area of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

298. Other Pre-specified Outcome

Title	Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
Count of Participants [Participants]	2 0.7%	0 0%

299. Other Pre-specified Outcome

Title	Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
Count of Participants [Participants]	2 0.7%	0 0%

300. Other Pre-specified Outcome

Title	Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

301. Other Pre-specified Outcome

Title	Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

302. Other Pre-specified Outcome

Title	Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

303. Other Pre-specified Outcome

Title	Device-related Complications in Device Group Subjects and Control Group Subjects Who Undergo the MitraClip Procedure
Time Frame	Through 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

304. Other Pre-specified Outcome

Title	Brain Natriuretic Peptide (BNP) or N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP Levels)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All available data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
BNP	1014.77 (1085.98)	1017.13 (1212.77)
NT-proBNP	5174.33 (6566.61)	5943.86 (8437.61)

305. Other Pre-specified Outcome

Title	BNP or NT-proBNP Levels
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

All available data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
BNP	875.91 (931.18)	1065.55 (1206.34)
NT-proBNP	4907.58 (7483.72)	5244.16 (7851.05)

306. Other Pre-specified Outcome

Title	BNP or NT-proBNP Levels
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All available data has been reported.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
BNP	621.45 (606.99)	808.26 (1711.71)
NT-proBNP	3362.49 (4332.12)	3977.80 (5689.70)

307. Other Pre-specified Outcome

Title	Modified Rankin Scale Score
Description	MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	308
0	170 56.3%	158 50.6%
1	52 17.2%	55 17.6%
2	55 18.2%	58 18.6%
3	23 7.6%	35 11.2%
4	2 0.7%	2 0.6%
5	0 0%	0 0%

308. Other Pre-specified Outcome

Title	Modified Rankin Scale Score
Description	MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	278	276
0	169 56%	129 41.3%
1	56 18.5%	54 17.3%
2	40 13.2%	49 15.7%
3	13 4.3%	34 10.9%
4	0 0%	8 2.6%
5	0 0%	2 0.6%

309. Other Pre-specified Outcome

Title	Modified Rankin Scale Score
Description	MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	250	234
0	145 48%	120 38.5%
1	60 19.9%	48 15.4%
2	30 9.9%	38 12.2%
3	13 4.3%	20 6.4%
4	2 0.7%	8 2.6%
5	0 0%	0 0%

310. Other Pre-specified Outcome

Title	Modified Rankin Scale Score
Description	MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	219	189
0	134 44.4%	100 32.1%
1	42 13.9%	40 12.8%
2	34 11.3%	27 8.7%
3	9 3%	14 4.5%
4	0 0%	7 2.2%
5	0 0%	1 0.3%

311. Other Pre-specified Outcome

Title	Major Bleeding
Description	Major bleeding is defined as bleeding ≥ Type 3 based on a modified Bleeding Academic Research Consortium (BARC) definition
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
Count of Participants [Participants]	15 5%	3 1%

312. Other Pre-specified Outcome

Title	Prolonged Ventilation
Description	Defined as pulmonary insufficiency requiring ventilatory support for greater than 48 hours post-catheterization
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

313. Other Pre-specified Outcome

Title	Average Dosages of Guideline Directed Medical Therapy (GDMT)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All available data has been reported and includes subjects on the drugs mentioned below. Not all subjects were on all the drugs.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
ACE Inhibitors	14.18 (15.19)	13.44 (13.56)
Angiotensin-Receptor Blockers (ARB)	14.21 (9.37)	12.35 (8.69)
Aldosterone Antagonists	24.51 (11.62)	28.96 (34.12)
Beta Blockers	31.91 (24.90)	29.92 (25.79)
Vasodilators (Nitrate)	59.61 (43.81)	42.80 (26.97)
Vasodilators (Hydralazine)	139.85 (108.46)	109.27 (86.45)
ARN Inhibitors	12.64 (9.31)	9.65 (6.80)

314. Other Pre-specified Outcome

Title	Average Dosages of GDMT
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

All available data has been reported and includes subjects on the drugs mentioned below. Not all subjects were on all the drugs.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
ACE Inhibitors	13.61 (15.01)	13.53 (13.68)
Angiotensin Receptor Blockers (ARBs)	13.68 (9.34)	11.89 (8.76)
Aldosterone Antagonists	24.21 (11.56)	29.48 (34.36)
Beta Blockers	30.12 (24.81)	29.25 (25.26)
Vasodilators (Nitrate)	56.38 (42.76)	43.79 (27.15)
Vasodilators (Hydralazine)	133.41 (108.29)	110.53 (87.72)
ARN Inhibitors	13.17 (11.15)	8.85 (5.98)

315. Other Pre-specified Outcome

Title	Average Dosages of GDMT
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All available data has been reported and includes subjects on the drugs mentioned below. Not all subjects were on all the drugs.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
ACE I	13.22 (14.59)	12.90 (12.96)
ARB	13.73 (8.93)	12.02 (8.63)
Aldosterone Antagonists	24.16 (11.19)	29.42 (32.68)
Beta Blockers	30.01 (24.94)	28.53 (25.13)
Vasodilators (Nitrate)	55.48 (41.64)	48.59 (34.90)
Vasodilators (Hydralazine)	133.82 (104.93)	109.01 (87.22)
ARNI	10.13 (8.15)	7.68 (4.71)

316. Other Pre-specified Outcome

Title	Average Dosages of GDMT
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All available data has been reported and includes subjects on the drugs mentioned below. Not all subjects were on all the drugs.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
ACE Inhibitors	12.73 (13.56)	12.41 (12.82)
ARBs	13.76 (9.21)	11.90 (8.45)
Aldosterone Antagonists	24.33 (12.17)	29.45 (32.58)
Beta Blockers	30.10 (24.99)	28.19 (24.65)
Vasodilators (Nitrate)	56.85 (41.50)	48.56 (34.95)
Vasodilators (Hydralazine)	136.51 (99.05)	108.74 (87.89)
ARN Inhibitors	10.36 (7.57)	7.99 (4.51)

317. Other Pre-specified Outcome

Title	Average Dosages of GDMT
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

All available data has been reported and includes subjects on the drugs mentioned below. Not all subjects were on all the drugs.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
ACe Inhibitors	12.35 (13.36)	12.32 (12.91)
ARBs	13.86 (9.10)	11.67 (8.09)
Aldosterone Antagonists	24.36 (12.30)	28.98 (32.00)
Beta Blockers	30.50 (25.15)	27.66 (23.70)
Vasodilators (Nitrate)	54.81 (41.50)	45.53 (33.30)
Vasodilators (Hydralazine)	135.20 (97.01)	102.29 (85.28)
ARN Inhibitors	10.41 (7.34)	8.52 (5.40)

318. Other Pre-specified Outcome

Title	Average Dosages of GDMT
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

319. Other Pre-specified Outcome

Title	Average Dosages of GDMT
Time Frame	4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

320. Other Pre-specified Outcome

Title	Average Dosages of GDMT
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

321. Other Pre-specified Outcome

Title	The Number of Subjects With Changes in GDMT Dosage From Baseline
Time Frame	Between baseline and 30 days

Outcome Measure Data

Analysis Population Description

Not all subjects were on all the drugs.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
ACE-Inhibitors	44 14.6%	23 7.4%
Angiotensin-Receptor Blocker (ARBs)	20 6.6%	20 6.4%
Aldosterone Antagonists	29 9.6%	25 8%
Beta Blocker	60 19.9%	48 15.4%
Vasodilators (Nitrate)	10 3.3%	12 3.8%
Vasodilators (Hydralazine)	11 3.6%	13 4.2%

322. Other Pre-specified Outcome

Title	The Number of Subjects With Changes in GDMT Dosage From Baseline to 6 Months
Time Frame	Between baseline and 6 months

Outcome Measure Data

Analysis Population Description

Not all subjects were on all the drugs.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
ACE-Inhibitors	53 17.5%	41 13.1%
Angiotensin-Receptor Blockers (ARBs)	35 11.6%	27 8.7%
Aldosterone Antagonists	44 14.6%	35 11.2%
Beta Blocker	74 24.5%	60 19.2%
Vasodilators (Nitrate)	14 4.6%	18 5.8%
Vasodilators (Hydralazine)	15 5%	20 6.4%

323. Other Pre-specified Outcome

Title	The Number of Subjects With Changes in GDMT Dosage From Baseline and 12 Months
Time Frame	Between baseline and 12 months

Outcome Measure Data

Analysis Population Description

Not all subjects were on all the drugs.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
ACE-Inhibitors	61 20.2%	37 11.9%
Angiotension-Receptor Blockers (ARBs)	14 4.6%	38 12.2%
Aldosterone Antagonists	44 14.6%	44 14.1%
Beta Blocker	76 25.2%	66 21.2%
Vasodilators (Nitrate)	14 4.6%	19 6.1%
Vasodilators (Hydralazine)	14 4.6%	14 4.5%

324. Other Pre-specified Outcome

Title	The Number of Subjects With Changes in GDMT Dosage From Baseline and 24 Months
Time Frame	Between baseline and 24 months

Outcome Measure Data

Analysis Population Description

Not all subjects were on all the drugs.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
ACE-Inhibitors	36 11.9%	24 7.7%
Angiotensin-Receptor Blockers (ARBs)	29 9.6%	21 6.7%
Aldosterone Antagonists	28 9.3%	21 6.7%
Beta Blockers	43 14.2%	34 10.9%
Vasodilators (Nitrate)	7 2.3%	11 3.5%
Vasodilators (Hydralazine)	10 3.3%	14 4.5%

325. Other Pre-specified Outcome

Title	The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline
Time Frame	Between baseline and 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

326. Other Pre-specified Outcome

Title	The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline
Time Frame	Between baseline and 4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

327. Other Pre-specified Outcome

Title	The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline
Time Frame	Between baseline and 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

328. Other Pre-specified Outcome

Title	The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose
Time Frame	Between baseline and 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
ACE-Inhibitors (Decrease > 50% or Stop)	0 0%	0 0%
ACE-Inhibitors (Increase > 100% or New Class)	1 0.3%	1 0.3%
ARB (Decrease > 50% or Stop)	1 0.3%	0 0%
ARB (Increase > 100% or New Class)	0 0%	1 0.3%
Aldosterone Antagonists (Decrease > 50% or stop)	0 0%	0 0%
Aldosterone Antagonists (Increase>100%orNewClass)	2 0.7%	2 0.6%
Beta Blockers (Decrease > 50% or Stop)	2 0.7%	0 0%
Beta Blockers (Increase >100% or New Class)	2 0.7%	2 0.6%
Vasodilators (Nitrate) Decrease>50% or Stop	0 0%	0 0%
Vasodilators (Nitrate) Increase > 100% or NewClass	1 0.3%	0 0%
Vasodilators (Hydralazine) Decrease>50% or Stop	0 0%	0 0%
Vasodilators(Hydralazine)Increase >100% orNewClass	1 0.3%	1 0.3%
ARN Inhibitors - Decrease>50% or Stop	0 0%	0 0%
ARN Inhibitors - Increase > 100% or NewClass	0 0%	0 0%

329. Other Pre-specified Outcome

Title	The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose
Time Frame	Between baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
ACE-I (Decrease > 50% or Stop)	8 2.6%	4 1.3%
ACE-I (Increase > 100% or New Class)	6 2%	4 1.3%
ARB (Decrease > 50% or Stop)	2 0.7%	1 0.3%
ARB (Increase > 100% or New Class)	7 2.3%	9 2.9%
Aldosterone Antagonists (Decrease > 50% or Stop)	1 0.3%	1 0.3%
Aldosterone Antagonists (Increase > 100% or NewCl)	11 3.6%	7 2.2%
Beta Blockers (Decrease > 50% or Stop)	14 4.6%	10 3.2%
Beta Blockers (Increase > 100% or New Class)	19 6.3%	9 2.9%
Vasodilators (Nitrate) Decrease > 50% or Stop	0 0%	0 0%
Vasodilators (Nitrate) Increase > 100% or NewClass	1 0.3%	5 1.6%
Vasodilators (Hydralazine) Decrease > 50% or Stop	1 0.3%	0 0%
Vasodilators(Hydralazine)Increase>100% orNewClass	7 2.3%	6 1.9%
ARN Inhibitors Decrease > 50% or Stop	0 0%	0 0%
ARN Inhibitors Increase > 100% or New Class	6 2%	12 3.8%

330. Other Pre-specified Outcome

Title	The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose
Time Frame	Between baseline and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
ACE-Inhibitors Decrease > 50% or Stop	13 4.3%	5 1.6%
ACE-Inhibitors Increase > 100% or New Class	9 3%	8 2.6%
ARBs Decrease >50% or Stop	3 1%	2 0.6%
ARBs Increase > 100% or New Class	13 4.3%	12 3.8%
Aldosterone Antagonists Decrease > 50% or Stop	2 0.7%	2 0.6%
Aldosterone Antagonists Increase>100% or New Class	16 5.3%	8 2.6%
Beta Blockers Decrease > 50% or Stop	16 5.3%	16 5.1%
Beta Blockers Increase > 100% or New Class	26 8.6%	12 3.8%
Vasodilators(Nitrate) Decrease > 50% or Stop	0 0%	0 0%
Vasodilators(Nitrate) Increase > 100% or New Class	3 1%	6 1.9%
Vasodilators(Hydralazine) Decrease > 50% or Stop	3 1%	0 0%
Vasodilators(Hydralazine) Increase>100%orNewClass	13 4.3%	12 3.8%
ARN Inhibitors Decrease > 50% or Stop	0 0%	0 0%
ARN inhibitors Increase > 100% or New Class	13 4.3%	20 6.4%

331. Other Pre-specified Outcome

Title	The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose
Time Frame	Between baseline and 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	302	312
ACE-Inhibitors Decrease > 50% or Stop	17 5.6%	6 1.9%
ACE Inhibitors Increase > 100% or New Class	14 4.6%	11 3.5%
ARBs Decrease > 50% or Stop	3 1%	2 0.6%
ARBs Increase > 100% or New Class	19 6.3%	16 5.1%
Aldosterone Antagonists Decrease > 50% or Stop	2 0.7%	3 1%
Aldosterone Antagonists Increase>100% or New Class	21 7%	10 3.2%
Beta Blockers Decrease > 50% or Stop	20 6.6%	26 8.3%
Beta Blockers Increase > 100% or New Class	29 9.6%	19 6.1%
Vasodilators(Nitrate) Decrease > 50% or Stop	0 0%	1 0.3%
Vasodilators(Nitrate) Increase > 100% or New Class	5 1.7%	11 3.5%
Vasodilators(Hydralazine)Decrease > 50% or Stop	6 2%	1 0.3%
Vasodilators(Hydralazine) Increase>100%orNew Class	14 4.6%	20 6.4%
ARN Inhibitors Decrease > 50% or Stop	0 0%	0 0%
ARN Inhibitors Increase > 100% or New Class	26 8.6%	24 7.7%

332. Other Pre-specified Outcome

Title	The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose
Time Frame	Between baseline and 3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

333. Other Pre-specified Outcome

Title	The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose
Time Frame	Between baseline and 4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

334. Other Pre-specified Outcome

Title	The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose
Time Frame	Between baseline and 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

335. Other Pre-specified Outcome

Title	Cardiopulmonary Exercise (CPX) Testing
Description	A substudy endpoint will utilize peak oxygen consumption oxygen uptake (VO2) as a parameter for cardiopulmonary exercise testing on a total of at least 50 and up to 100 subjects. The CPX analysis variables are: Peak VO2 (ml/kg/min) - CPX Sub-study endpoint, descriptive analysis only, not powered for statistical significance Exercise duration (min) Peak workload (watts) Maximum heart rate during exercise (beats/min) Peak VE (l/min) Respiratory Exchange Ratio (RER, VCO2/VO2) VE/VCO2 slope Ventilatory Threshold (ml/kg/min) Borg scale Exercise termination reason Type of exercise (treadmill vs cycling)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

A total of 14 subjects were enrolled in the CPA sub study. However CPX data was available for only 2 subjects in the device group and 1 subject in the control group.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	2	1
Mean (Standard Deviation) [ml/kg/min]	12.85 (0.78)	6.00 (NA)

336. Other Pre-specified Outcome

Title	Cardiopulmonary Exercise (CPX) Testing
Description	A substudy endpoint will utilize peak oxygen consumption oxygen uptake (VO2) as a parameter for cardiopulmonary exercise testing on a total of at least 50 and up to 100 subjects. The CPX analysis variables are: Peak VO2 (ml/kg/min) - CPX Sub-study endpoint, descriptive analysis only, not powered for statistical significance Exercise duration (min) Peak workload (watts) Maximum heart rate during exercise (beats/min) Peak VE (l/min) Respiratory Exchange Ratio (RER, VCO2/VO2) VE/VCO2 slope Ventilatory Threshold (ml/kg/min) Borg scale Exercise termination reason Type of exercise (treadmill vs cycling)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

A total of 14 subjects participated in the CPX sub-study. CPX test data was available in 2 subjects in the device group and 1 subject in the control group.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	2	1
Mean (Standard Deviation) [ml/kg/min]	14.50 (6.36)	6.80 (NA)

337. Other Pre-specified Outcome

Title	Cardiopulmonary Exercise (CPX) Testing: Mean Changes in Peak VO2
Description	Mean changes in peak VO2 (ml/kg/min) will be summarized at 12 months from baseline for the subset of patients who complete a CPX test at baseline and 12 months. A comparison of change from baseline between Device and Control groups will be presented. The CPX analysis variables are: Peak VO2 (ml/kg/min) - CPX Sub-study endpoint, descriptive analysis only, not powered for statistical significance Exercise duration (min) Peak workload (watts) Maximum heart rate during exercise (beats/min) Peak VE (l/min) Respiratory Exchange Ratio (RER, VCO2/VO2) VE/VCO2 slope Ventilatory Threshold (ml/kg/min) Borg scale Exercise termination reason Type of exercise (treadmill vs cycling)
Time Frame	Between baseline and 12 months

Outcome Measure Data

Analysis Population Description

A total of 14 subjects participated in the CPX sub-study. CPX test data was available in 2 subjects in the device group and 1 subject in the control group.

Arm/Group Title	MitraClip System	Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System	Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Measure Participants	2	1
Mean (Standard Deviation) [ml/kg/min]	1.65 (5.59)	0.80 (NA)

338. Other Pre-specified Outcome

Title	Health Economic Data
Time Frame	Through 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	24 Months
Arm/Group Title	MitraClip System		Control Group
Arm/Group Description	Percutaneous mitral valve repair using MitraClip System MitraClip System: Percutaneous mitral valve repair using MitraClip System		Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
All Cause Mortality
	MitraClip System		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	80/302 (26.5%)		121/312 (38.8%)
Serious Adverse Events
	MitraClip System		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	243/302 (80.5%)		264/312 (84.6%)
Blood and lymphatic system disorders
Anaemia	20/302 (6.6%)	23	9/312 (2.9%)	9
Anaemia Macrocytic	1/302 (0.3%)	1	1/312 (0.3%)	1
Anaemia of Chronic Disease	1/302 (0.3%)	1	1/312 (0.3%)	1
Coagulopathy	1/302 (0.3%)	1	3/312 (1%)	3
Haemorrhagic Anaemia	4/302 (1.3%)	4	2/312 (0.6%)	2
Iron Deficiency Anaemia	1/302 (0.3%)	1	1/312 (0.3%)	1
LEUKOCYTOSIS	0/302 (0%)	0	2/312 (0.6%)	2
MICROCYTIC ANAEMIA	0/302 (0%)	0	1/312 (0.3%)	1
PANCYTOPENIA	2/302 (0.7%)	2	1/312 (0.3%)	1
THROMBOCYTOPENIA	1/302 (0.3%)	1	2/312 (0.6%)	3
Cardiac disorders
ACUTE CORONARY SYNDROME	2/302 (0.7%)	2	0/312 (0%)	0
ACUTE LEFT VENTRICULAR FAILURE	0/302 (0%)	0	1/312 (0.3%)	1
ACUTE MYOCARDIAL INFARCTION	10/302 (3.3%)	11	16/312 (5.1%)	16
ANGINA PECTORIS	1/302 (0.3%)	1	3/312 (1%)	3
ANGINA UNSTABLE	2/302 (0.7%)	2	2/312 (0.6%)	2
ARRHYTHMIA	3/302 (1%)	3	3/312 (1%)	3
ARTERIOSCLEROSIS CORONARY ARTERY	2/302 (0.7%)	2	1/312 (0.3%)	1
ATRIAL FIBRILLATION	20/302 (6.6%)	28	21/312 (6.7%)	24
ATRIAL FLUTTER	6/302 (2%)	7	7/312 (2.2%)	7
ATRIAL SEPTAL DEFECT ACQUIRED	2/302 (0.7%)	2	0/312 (0%)	0
ATRIAL TACHYCARDIA	2/302 (0.7%)	2	0/312 (0%)	0
ATRIAL THROMBOSIS	3/302 (1%)	3	2/312 (0.6%)	2
ATRIOVENTRICULAR BLOCK COMPLETE	0/302 (0%)	0	1/312 (0.3%)	1
BRADYCARDIA	3/302 (1%)	3	1/312 (0.3%)	1
CARDIAC ARREST	12/302 (4%)	13	20/312 (6.4%)	20
CARDIAC FAILURE	27/302 (8.9%)	32	73/312 (23.4%)	102
CARDIAC FAILURE ACUTE	20/302 (6.6%)	22	24/312 (7.7%)	31
CARDIAC FAILURE CHRONIC	39/302 (12.9%)	59	59/312 (18.9%)	73
CARDIAC FAILURE CONGESTIVE	59/302 (19.5%)	84	83/312 (26.6%)	136
CARDIAC TAMPONADE	3/302 (1%)	3	0/312 (0%)	0
CARDIO-RESPIRATORY ARREST	5/302 (1.7%)	5	6/312 (1.9%)	6
CARDIOGENIC SHOCK	9/302 (3%)	10	13/312 (4.2%)	13
CARDIOMYOPATHY	4/302 (1.3%)	5	2/312 (0.6%)	2
CARDIOPULMONARY FAILURE	1/302 (0.3%)	1	0/312 (0%)	0
CARDIORENAL SYNDROME	1/302 (0.3%)	1	0/312 (0%)	0
CARDIOVASCULAR DECONDITIONING	1/302 (0.3%)	1	0/312 (0%)	0
CONGESTIVE CARDIOMYOPATHY	0/302 (0%)	0	1/312 (0.3%)	1
CORONARY ARTERY DISEASE	3/302 (1%)	3	5/312 (1.6%)	5
CORONARY ARTERY OCCLUSION	0/302 (0%)	0	1/312 (0.3%)	1
CORONARY ARTERY STENOSIS	1/302 (0.3%)	1	0/312 (0%)	0
INTRACARDIAC THROMBUS	2/302 (0.7%)	2	0/312 (0%)	0
ISCHAEMIC CARDIOMYOPATHY	3/302 (1%)	3	7/312 (2.2%)	7
LEFT VENTRICULAR DYSFUNCTION	1/302 (0.3%)	1	0/312 (0%)	0
LEFT VENTRICULAR FAILURE	1/302 (0.3%)	1	0/312 (0%)	0
MITRAL VALVE INCOMPETENCE	7/302 (2.3%)	7	8/312 (2.6%)	8
MITRAL VALVE STENOSIS	1/302 (0.3%)	1	1/312 (0.3%)	1
MYOCARDIAL INFARCTION	5/302 (1.7%)	5	5/312 (1.6%)	5
MYOCARDIAL ISCHAEMIA	1/302 (0.3%)	1	0/312 (0%)	0
PALPITATIONS	0/302 (0%)	0	1/312 (0.3%)	1
PERICARDIAL EFFUSION	7/302 (2.3%)	8	2/312 (0.6%)	2
PERICARDIAL HAEMORRHAGE	1/302 (0.3%)	1	1/312 (0.3%)	1
SICK SINUS SYNDROME	1/302 (0.3%)	1	1/312 (0.3%)	1
SUPRAVENTRICULAR TACHYCARDIA	3/302 (1%)	3	0/312 (0%)	0
SYSTOLIC DYSFUNCTION	1/302 (0.3%)	1	2/312 (0.6%)	2
TACHYARRHYTHMIA	2/302 (0.7%)	2	0/312 (0%)	0
TACHYCARDIA	1/302 (0.3%)	1	2/312 (0.6%)	2
TORSADE DE POINTES	1/302 (0.3%)	1	1/312 (0.3%)	1
TRICUSPID VALVE INCOMPETENCE	3/302 (1%)	3	1/312 (0.3%)	1
VENTRICULAR ARRHYTHMIA	0/302 (0%)	0	2/312 (0.6%)	2
VENTRICULAR DYSSYNCHRONY	0/302 (0%)	0	2/312 (0.6%)	2
VENTRICULAR EXTRASYSTOLES	0/302 (0%)	0	1/312 (0.3%)	1
VENTRICULAR FIBRILLATION	3/302 (1%)	4	7/312 (2.2%)	8
VENTRICULAR TACHYCARDIA	13/302 (4.3%)	20	23/312 (7.4%)	35
Ear and labyrinth disorders
VERTIGO	2/302 (0.7%)	2	0/312 (0%)	0
Eye disorders
CATARACT	2/302 (0.7%)	2	0/312 (0%)	0
CONJUNCTIVITIS	1/302 (0.3%)	1	0/312 (0%)	0
DIPLOPIA	0/302 (0%)	0	1/312 (0.3%)	1
VISION BLURRED	1/302 (0.3%)	1	0/312 (0%)	0
Gastrointestinal disorders
ABDOMINAL PAIN	3/302 (1%)	3	4/312 (1.3%)	4
ABDOMINAL PAIN UPPER	1/302 (0.3%)	1	1/312 (0.3%)	1
ACQUIRED OESOPHAGEAL WEB	0/302 (0%)	0	1/312 (0.3%)	1
ASCITES	5/302 (1.7%)	6	2/312 (0.6%)	3
COLITIS	3/302 (1%)	3	1/312 (0.3%)	1
COLITIS ISCHAEMIC	1/302 (0.3%)	1	1/312 (0.3%)	1
COLITIS ULCERATIVE	0/302 (0%)	0	1/312 (0.3%)	2
COLONIC PSEUDO-OBSTRUCTION	0/302 (0%)	0	1/312 (0.3%)	1
CONSTIPATION	1/302 (0.3%)	1	0/312 (0%)	0
DIABETIC GASTROPARESIS	0/302 (0%)	0	1/312 (0.3%)	1
DIARRHOEA	3/302 (1%)	3	3/312 (1%)	3
DIVERTICULAR PERFORATION	0/302 (0%)	0	1/312 (0.3%)	1
DIVERTICULUM INTESTINAL	1/302 (0.3%)	1	0/312 (0%)	0
DIVERTICULUM INTESTINAL HAEMORRHAGIC	1/302 (0.3%)	1	0/312 (0%)	0
DYSPHAGIA	5/302 (1.7%)	5	2/312 (0.6%)	2
ENTEROCUTANEOUS FISTULA	1/302 (0.3%)	1	0/312 (0%)	0
ENTEROVESICAL FISTULA	1/302 (0.3%)	1	0/312 (0%)	0
EROSIVE OESOPHAGITIS	1/302 (0.3%)	1	0/312 (0%)	0
FLATULENCE	1/302 (0.3%)	1	0/312 (0%)	0
GASTRITIS HAEMORRHAGIC	1/302 (0.3%)	1	0/312 (0%)	0
GASTROINTESTINAL ANGIODYSPLASIA	1/302 (0.3%)	1	1/312 (0.3%)	1
GASTROINTESTINAL HAEMORRHAGE	14/302 (4.6%)	17	19/312 (6.1%)	20
HAEMATEMESIS	1/302 (0.3%)	1	1/312 (0.3%)	1
HAEMORRHOIDAL HAEMORRHAGE	1/302 (0.3%)	1	0/312 (0%)	0
HAEMORRHOIDS	1/302 (0.3%)	1	0/312 (0%)	0
HIATUS HERNIA	0/302 (0%)	0	1/312 (0.3%)	1
IMPAIRED GASTRIC EMPTYING	0/302 (0%)	0	2/312 (0.6%)	2
INGUINAL HERNIA	3/302 (1%)	3	4/312 (1.3%)	4
INGUINAL HERNIA, OBSTRUCTIVE	0/302 (0%)	0	2/312 (0.6%)	2
INTESTINAL ISCHAEMIA	1/302 (0.3%)	1	0/312 (0%)	0
INTESTINAL OBSTRUCTION	1/302 (0.3%)	1	1/312 (0.3%)	1
INTESTINAL PERFORATION	0/302 (0%)	0	1/312 (0.3%)	1
JEJUNITIS	0/302 (0%)	0	1/312 (0.3%)	1
LARGE INTESTINE PERFORATION	1/302 (0.3%)	1	0/312 (0%)	0
LOWER GASTROINTESTINAL HAEMORRHAGE	1/302 (0.3%)	1	3/312 (1%)	3
MEGACOLON	1/302 (0.3%)	1	0/312 (0%)	0
MELAENA	0/302 (0%)	0	1/312 (0.3%)	1
NAUSEA	0/302 (0%)	0	1/312 (0.3%)	1
ODYNOPHAGIA	0/302 (0%)	0	1/312 (0.3%)	1
OESOPHAGEAL ULCER	0/302 (0%)	0	2/312 (0.6%)	2
PANCREATITIS	0/302 (0%)	0	1/312 (0.3%)	1
PANCREATITIS ACUTE	0/302 (0%)	0	1/312 (0.3%)	1
PROCTALGIA	0/302 (0%)	0	1/312 (0.3%)	1
PROCTITIS	1/302 (0.3%)	1	0/312 (0%)	0
RECTAL HAEMORRHAGE	4/302 (1.3%)	4	0/312 (0%)	0
RECTAL PROLAPSE	1/302 (0.3%)	1	0/312 (0%)	0
RECTAL ULCER	0/302 (0%)	0	1/312 (0.3%)	1
RECTAL ULCER HAEMORRHAGE	0/302 (0%)	0	1/312 (0.3%)	1
RETROPERITONEAL HAEMATOMA	2/302 (0.7%)	2	0/312 (0%)	0
RETROPERITONEAL HAEMORRHAGE	1/302 (0.3%)	1	0/312 (0%)	0
SMALL INTESTINAL OBSTRUCTION	0/302 (0%)	0	2/312 (0.6%)	2
UMBILICAL HERNIA	0/302 (0%)	0	1/312 (0.3%)	1
UPPER GASTROINTESTINAL HAEMORRHAGE	3/302 (1%)	5	0/312 (0%)	0
VOLVULUS	0/302 (0%)	0	1/312 (0.3%)	1
VOMITING	1/302 (0.3%)	1	4/312 (1.3%)	5
General disorders
ADVERSE DRUG REACTION	2/302 (0.7%)	2	2/312 (0.6%)	2
ASTHENIA	4/302 (1.3%)	4	4/312 (1.3%)	6
CATHETER SITE HAEMATOMA	0/302 (0%)	0	1/312 (0.3%)	1
CATHETER SITE HAEMORRHAGE	4/302 (1.3%)	4	0/312 (0%)	0
CHEST DISCOMFORT	1/302 (0.3%)	1	2/312 (0.6%)	2
CHEST PAIN	9/302 (3%)	12	11/312 (3.5%)	15
DEATH	6/302 (2%)	6	9/312 (2.9%)	9
DEVICE BATTERY ISSUE	1/302 (0.3%)	1	0/312 (0%)	0
DEVICE DISLOCATION	6/302 (2%)	6	0/312 (0%)	0
DEVICE ELECTRICAL FINDING	4/302 (1.3%)	5	2/312 (0.6%)	3
DEVICE LEAD DAMAGE	1/302 (0.3%)	1	0/312 (0%)	0
DEVICE LEAD ISSUE	1/302 (0.3%)	1	0/312 (0%)	0
DEVICE MALFUNCTION	3/302 (1%)	3	0/312 (0%)	0
DRUG INTOLERANCE	0/302 (0%)	0	1/312 (0.3%)	1
EXERCISE TOLERANCE DECREASED	0/302 (0%)	0	1/312 (0.3%)	1
FATIGUE	1/302 (0.3%)	1	2/312 (0.6%)	2
GENERAL PHYSICAL HEALTH DETERIORATION	1/302 (0.3%)	2	0/312 (0%)	0
HERNIA	1/302 (0.3%)	1	0/312 (0%)	0
HERNIA OBSTRUCTIVE	1/302 (0.3%)	1	0/312 (0%)	0
MEDICAL DEVICE COMPLICATION	1/302 (0.3%)	1	2/312 (0.6%)	2
MULTI-ORGAN FAILURE	1/302 (0.3%)	1	3/312 (1%)	3
NON-CARDIAC CHEST PAIN	5/302 (1.7%)	6	6/312 (1.9%)	9
OEDEMA PERIPHERAL	0/302 (0%)	0	3/312 (1%)	3
PYREXIA	2/302 (0.7%)	2	2/312 (0.6%)	3
SUDDEN CARDIAC DEATH	2/302 (0.7%)	2	1/312 (0.3%)	1
VESSEL PUNCTURE SITE HAEMATOMA	1/302 (0.3%)	1	0/312 (0%)	0
Hepatobiliary disorders
BILE DUCT STONE	1/302 (0.3%)	1	0/312 (0%)	0
CHOLECYSTITIS	2/302 (0.7%)	2	1/312 (0.3%)	1
CHOLECYSTITIS ACUTE	2/302 (0.7%)	2	1/312 (0.3%)	1
CHOLELITHIASIS	2/302 (0.7%)	2	1/312 (0.3%)	1
HEPATIC CIRRHOSIS	1/302 (0.3%)	1	0/312 (0%)	0
HEPATIC MASS	0/302 (0%)	0	1/312 (0.3%)	1
ISCHAEMIC HEPATITIS	0/302 (0%)	0	1/312 (0.3%)	1
Immune system disorders
ANAPHYLACTIC REACTION	1/302 (0.3%)	1	0/312 (0%)	0
HEART TRANSPLANT REJECTION	2/302 (0.7%)	2	0/312 (0%)	0
IMMUNOSUPPRESSION	0/302 (0%)	0	1/312 (0.3%)	1
TRANSPLANT REJECTION	1/302 (0.3%)	1	0/312 (0%)	0
Infections and infestations
ABDOMINAL ABSCESS	1/302 (0.3%)	1	0/312 (0%)	0
ABSCESS LIMB	1/302 (0.3%)	1	0/312 (0%)	0
ACQUIRED IMMUNODEFICIENCY SYNDROME	0/302 (0%)	0	1/312 (0.3%)	1
BACTERAEMIA	4/302 (1.3%)	5	0/312 (0%)	0
BACTERIAL SEPSIS	0/302 (0%)	0	1/312 (0.3%)	1
BRONCHITIS	1/302 (0.3%)	1	2/312 (0.6%)	2
BRONCHITIS VIRAL	1/302 (0.3%)	1	1/312 (0.3%)	1
BRONCHOPNEUMONIA	0/302 (0%)	0	1/312 (0.3%)	1
CELLULITIS	5/302 (1.7%)	5	6/312 (1.9%)	7
CLOSTRIDIAL INFECTION	1/302 (0.3%)	1	1/312 (0.3%)	1
CLOSTRIDIUM DIFFICILE COLITIS	1/302 (0.3%)	2	3/312 (1%)	4
CYSTITIS	1/302 (0.3%)	1	0/312 (0%)	0
DEVICE RELATED INFECTION	1/302 (0.3%)	1	2/312 (0.6%)	4
DEVICE RELATED SEPSIS	0/302 (0%)	0	1/312 (0.3%)	1
DIVERTICULITIS	2/302 (0.7%)	2	2/312 (0.6%)	2
EMPHYSEMATOUS CYSTITIS	1/302 (0.3%)	1	0/312 (0%)	0
ENTEROCOCCAL BACTERAEMIA	1/302 (0.3%)	1	1/312 (0.3%)	1
ENTEROCOLITIS INFECTIOUS	1/302 (0.3%)	1	0/312 (0%)	0
ESCHERICHIA BACTERAEMIA	1/302 (0.3%)	1	0/312 (0%)	0
ESCHERICHIA INFECTION	0/302 (0%)	0	1/312 (0.3%)	1
FUNGAEMIA	1/302 (0.3%)	1	0/312 (0%)	0
GANGRENE	2/302 (0.7%)	2	0/312 (0%)	0
GASTROENTERITIS VIRAL	0/302 (0%)	0	2/312 (0.6%)	2
HERPES ZOSTER	2/302 (0.7%)	2	0/312 (0%)	0
IMPLANT SITE INFECTION	0/302 (0%)	0	1/312 (0.3%)	1
INFECTION	1/302 (0.3%)	1	0/312 (0%)	0
INFLUENZA	3/302 (1%)	3	6/312 (1.9%)	6
INFUSION SITE CELLULITIS	1/302 (0.3%)	1	0/312 (0%)	0
KLEBSIELLA BACTERAEMIA	1/302 (0.3%)	1	0/312 (0%)	0
LOBAR PNEUMONIA	2/302 (0.7%)	2	1/312 (0.3%)	1
LOWER RESPIRATORY TRACT INFECTION	0/302 (0%)	0	1/312 (0.3%)	1
OESOPHAGEAL INFECTION	0/302 (0%)	0	1/312 (0.3%)	1
OSTEOMYELITIS	1/302 (0.3%)	1	1/312 (0.3%)	1
PARAINFLUENZAE VIRUS INFECTION	1/302 (0.3%)	1	0/312 (0%)	0
PERIRECTAL ABSCESS	1/302 (0.3%)	1	0/312 (0%)	0
PERITONITIS	2/302 (0.7%)	2	1/312 (0.3%)	1
PNEUMONIA	19/302 (6.3%)	25	24/312 (7.7%)	26
PNEUMONIA BACTERIAL	0/302 (0%)	0	1/312 (0.3%)	1
PNEUMONIA INFLUENZAL	0/302 (0%)	0	1/312 (0.3%)	1
PNEUMONIA NECROTISING	1/302 (0.3%)	1	0/312 (0%)	0
PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL	0/302 (0%)	0	1/312 (0.3%)	1
PNEUMONIA STAPHYLOCOCCAL	0/302 (0%)	0	1/312 (0.3%)	1
POST VIRAL FATIGUE SYNDROME	0/302 (0%)	0	1/312 (0.3%)	1
PULMONARY SEPSIS	1/302 (0.3%)	1	0/312 (0%)	0
PYELONEPHRITIS	1/302 (0.3%)	1	1/312 (0.3%)	1
RESPIRATORY TRACT INFECTION	1/302 (0.3%)	1	1/312 (0.3%)	1
SEPSIS	14/302 (4.6%)	16	10/312 (3.2%)	12
SEPSIS SYNDROME	1/302 (0.3%)	1	0/312 (0%)	0
SEPTIC SHOCK	5/302 (1.7%)	5	8/312 (2.6%)	8
SOFT TISSUE INFECTION	1/302 (0.3%)	1	0/312 (0%)	0
STAPHYLOCOCCAL BACTERAEMIA	2/302 (0.7%)	2	1/312 (0.3%)	1
STAPHYLOCOCCAL INFECTION	1/302 (0.3%)	1	1/312 (0.3%)	1
STREPTOCOCCAL BACTERAEMIA	0/302 (0%)	0	2/312 (0.6%)	2
SUBCUTANEOUS ABSCESS	0/302 (0%)	0	1/312 (0.3%)	1
TRACHEOBRONCHITIS VIRAL	0/302 (0%)	0	1/312 (0.3%)	1
TUBERCULOSIS	0/302 (0%)	0	1/312 (0.3%)	1
URINARY TRACT INFECTION	4/302 (1.3%)	7	4/312 (1.3%)	4
URINARY TRACT INFECTION BACTERIAL	0/302 (0%)	0	1/312 (0.3%)	1
URINARY TRACT INFECTION FUNGAL	1/302 (0.3%)	1	0/312 (0%)	0
UROSEPSIS	3/302 (1%)	3	2/312 (0.6%)	2
Injury, poisoning and procedural complications
ANAEMIA POSTOPERATIVE	2/302 (0.7%)	2	1/312 (0.3%)	1
ANAESTHETIC COMPLICATION PULMONARY	0/302 (0%)	0	1/312 (0.3%)	1
ARTERIOVENOUS FISTULA THROMBOSIS	0/302 (0%)	0	1/312 (0.3%)	1
ARTHROPOD BITE	0/302 (0%)	0	1/312 (0.3%)	1
CARDIAC VALVE REPLACEMENT COMPLICATION	1/302 (0.3%)	1	0/312 (0%)	0
CERVICAL VERTEBRAL FRACTURE	3/302 (1%)	3	1/312 (0.3%)	1
COMPLICATIONS OF TRANSPLANTED HEART	0/302 (0%)	0	1/312 (0.3%)	2
CONTUSION	1/302 (0.3%)	1	0/312 (0%)	0
CRANIOCEREBRAL INJURY	2/302 (0.7%)	2	2/312 (0.6%)	2
FACE INJURY	1/302 (0.3%)	1	0/312 (0%)	0
FACIAL BONES FRACTURE	0/302 (0%)	0	1/312 (0.3%)	1
FALL	11/302 (3.6%)	11	11/312 (3.5%)	11
FEMORAL NECK FRACTURE	0/302 (0%)	0	1/312 (0.3%)	1
FEMUR FRACTURE	4/302 (1.3%)	4	4/312 (1.3%)	4
FRACTURE DISPLACEMENT	1/302 (0.3%)	1	0/312 (0%)	0
FRACTURED SACRUM	0/302 (0%)	0	1/312 (0.3%)	1
GASTROENTERITIS RADIATION	1/302 (0.3%)	7	0/312 (0%)	0
HAEMATURIA TRAUMATIC	1/302 (0.3%)	1	0/312 (0%)	0
HEAD INJURY	0/302 (0%)	0	3/312 (1%)	3
HIP FRACTURE	3/302 (1%)	3	5/312 (1.6%)	5
HUMERUS FRACTURE	2/302 (0.7%)	2	0/312 (0%)	0
IN-STENT CORONARY ARTERY RESTENOSIS	0/302 (0%)	0	1/312 (0.3%)	1
INJURY	0/302 (0%)	0	1/312 (0.3%)	1
LACERATION	0/302 (0%)	0	2/312 (0.6%)	2
PELVIC FRACTURE	0/302 (0%)	0	2/312 (0.6%)	3
POCKET EROSION	0/302 (0%)	0	1/312 (0.3%)	1
POST PROCEDURAL HAEMATOMA	1/302 (0.3%)	1	1/312 (0.3%)	1
POST PROCEDURAL HAEMORRHAGE	2/302 (0.7%)	2	3/312 (1%)	5
POSTOPERATIVE ILEUS	1/302 (0.3%)	1	0/312 (0%)	0
PROCEDURAL COMPLICATION	2/302 (0.7%)	2	0/312 (0%)	0
PROCEDURAL HAEMORRHAGE	0/302 (0%)	0	2/312 (0.6%)	2
PROCEDURAL HYPOTENSION	1/302 (0.3%)	1	3/312 (1%)	3
PROCEDURAL PAIN	1/302 (0.3%)	1	0/312 (0%)	0
PUBIS FRACTURE	2/302 (0.7%)	2	0/312 (0%)	0
RADIUS FRACTURE	1/302 (0.3%)	1	0/312 (0%)	0
RENAL HAEMATOMA	1/302 (0.3%)	1	0/312 (0%)	0
RIB FRACTURE	2/302 (0.7%)	2	2/312 (0.6%)	2
SPINAL COMPRESSION FRACTURE	1/302 (0.3%)	1	1/312 (0.3%)	1
SPINAL FRACTURE	1/302 (0.3%)	1	0/312 (0%)	0
SUBDURAL HAEMATOMA	4/302 (1.3%)	4	3/312 (1%)	3
TOXICITY TO VARIOUS AGENTS	0/302 (0%)	0	1/312 (0.3%)	1
TRAUMATIC HAEMATOMA	2/302 (0.7%)	2	0/312 (0%)	0
TRAUMATIC INTRACRANIAL HAEMORRHAGE	4/302 (1.3%)	4	2/312 (0.6%)	2
UPPER LIMB FRACTURE	1/302 (0.3%)	1	0/312 (0%)	0
VASCULAR ACCESS COMPLICATION	1/302 (0.3%)	1	0/312 (0%)	0
VASCULAR PSEUDOANEURYSM	0/302 (0%)	0	1/312 (0.3%)	1
VENA CAVA INJURY	1/302 (0.3%)	1	0/312 (0%)	0
WOUND	0/302 (0%)	0	1/312 (0.3%)	1
Investigations
ANTICOAGULATION DRUG LEVEL BELOW THERAPEUTIC	2/302 (0.7%)	2	0/312 (0%)	0
CARDIAC ENZYMES INCREASED	0/302 (0%)	0	1/312 (0.3%)	1
CARDIAC OUTPUT DECREASED	0/302 (0%)	0	1/312 (0.3%)	1
CATHETERISATION CARDIAC	1/302 (0.3%)	1	0/312 (0%)	0
COLONOSCOPY	1/302 (0.3%)	1	0/312 (0%)	0
DRUG LEVEL ABOVE THERAPEUTIC	1/302 (0.3%)	1	0/312 (0%)	0
EJECTION FRACTION DECREASED	2/302 (0.7%)	2	0/312 (0%)	0
ELECTROCARDIOGRAM AMBULATORY ABNORMAL	0/302 (0%)	0	1/312 (0.3%)	1
ELECTROCARDIOGRAM QRS COMPLEX PROLONGED	0/302 (0%)	0	1/312 (0.3%)	1
ELECTROCARDIOGRAM QT PROLONGED	0/302 (0%)	0	1/312 (0.3%)	1
ELECTROCARDIOGRAM ST SEGMENT ELEVATION	1/302 (0.3%)	1	0/312 (0%)	0
ENTEROCOCCUS TEST POSITIVE	0/302 (0%)	0	1/312 (0.3%)	1
HAEMOGLOBIN DECREASED	1/302 (0.3%)	1	0/312 (0%)	0
INFLUENZA A VIRUS TEST POSITIVE	1/302 (0.3%)	1	0/312 (0%)	0
INTERNATIONAL NORMALISED RATIO DECREASED	0/302 (0%)	0	1/312 (0.3%)	1
INTERNATIONAL NORMALISED RATIO INCREASED	0/302 (0%)	0	2/312 (0.6%)	2
LABORATORY TEST ABNORMAL	0/302 (0%)	0	1/312 (0.3%)	1
LIVER FUNCTION TEST ABNORMAL	2/302 (0.7%)	2	1/312 (0.3%)	1
TRANSAMINASES INCREASED	1/302 (0.3%)	1	1/312 (0.3%)	1
TROPONIN INCREASED	1/302 (0.3%)	1	0/312 (0%)	0
URINE OUTPUT DECREASED	1/302 (0.3%)	1	0/312 (0%)	0
WHITE BLOOD CELL COUNT INCREASED	1/302 (0.3%)	1	0/312 (0%)	0
Metabolism and nutrition disorders
ACIDOSIS	0/302 (0%)	0	1/312 (0.3%)	1
DEHYDRATION	1/302 (0.3%)	1	1/312 (0.3%)	1
DIABETES MELLITUS	0/302 (0%)	0	1/312 (0.3%)	1
DIABETIC KETOACIDOSIS	1/302 (0.3%)	1	1/312 (0.3%)	1
ELECTROLYTE IMBALANCE	1/302 (0.3%)	1	0/312 (0%)	0
FAILURE TO THRIVE	1/302 (0.3%)	1	2/312 (0.6%)	2
FLUID OVERLOAD	5/302 (1.7%)	6	5/312 (1.6%)	5
GOUT	4/302 (1.3%)	4	1/312 (0.3%)	1
HYPERGLYCAEMIA	2/302 (0.7%)	2	4/312 (1.3%)	4
HYPERKALAEMIA	2/302 (0.7%)	2	5/312 (1.6%)	6
HYPOGLYCAEMIA	1/302 (0.3%)	1	2/312 (0.6%)	2
HYPOKALAEMIA	3/302 (1%)	3	3/312 (1%)	4
HYPONATRAEMIA	3/302 (1%)	3	1/312 (0.3%)	1
HYPOVOLAEMIA	1/302 (0.3%)	1	1/312 (0.3%)	1
IRON DEFICIENCY	0/302 (0%)	0	1/312 (0.3%)	1
LACTIC ACIDOSIS	0/302 (0%)	0	1/312 (0.3%)	1
METABOLIC ACIDOSIS	1/302 (0.3%)	1	1/312 (0.3%)	1
METABOLIC ALKALOSIS	0/302 (0%)	0	1/312 (0.3%)	1
Musculoskeletal and connective tissue disorders
ARTHRALGIA	0/302 (0%)	0	1/312 (0.3%)	1
ARTHRITIS	2/302 (0.7%)	2	1/312 (0.3%)	1
BACK PAIN	1/302 (0.3%)	1	0/312 (0%)	0
CERVICAL SPINAL STENOSIS	0/302 (0%)	0	1/312 (0.3%)	1
GOUTY ARTHRITIS	1/302 (0.3%)	1	0/312 (0%)	0
INTERVERTEBRAL DISC DEGENERATION	0/302 (0%)	0	1/312 (0.3%)	1
INTERVERTEBRAL DISC PROTRUSION	0/302 (0%)	0	2/312 (0.6%)	2
LUMBAR SPINAL STENOSIS	1/302 (0.3%)	1	0/312 (0%)	0
MUSCLE HAEMORRHAGE	0/302 (0%)	0	1/312 (0.3%)	1
MUSCLE SPASMS	0/302 (0%)	0	2/312 (0.6%)	2
MUSCULAR WEAKNESS	0/302 (0%)	0	1/312 (0.3%)	1
MUSCULOSKELETAL CHEST PAIN	1/302 (0.3%)	1	0/312 (0%)	0
MUSCULOSKELETAL PAIN	0/302 (0%)	0	2/312 (0.6%)	2
NECK PAIN	1/302 (0.3%)	1	0/312 (0%)	0
OSTEOARTHRITIS	6/302 (2%)	7	1/312 (0.3%)	1
PAIN IN EXTREMITY	1/302 (0.3%)	1	3/312 (1%)	4
RHABDOMYOLYSIS	0/302 (0%)	0	1/312 (0.3%)	1
SPINAL COLUMN STENOSIS	1/302 (0.3%)	1	1/312 (0.3%)	1
VERTEBRAL FORAMINAL STENOSIS	0/302 (0%)	0	1/312 (0.3%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ANGIOSARCOMA METASTATIC	1/302 (0.3%)	1	0/312 (0%)	0
B-CELL LYMPHOMA	1/302 (0.3%)	1	0/312 (0%)	0
BASAL CELL CARCINOMA	1/302 (0.3%)	1	0/312 (0%)	0
BONE SARCOMA	0/302 (0%)	0	1/312 (0.3%)	1
BREAST CANCER	1/302 (0.3%)	1	0/312 (0%)	0
COLON CANCER	0/302 (0%)	0	1/312 (0.3%)	1
HEPATIC NEOPLASM MALIGNANT	1/302 (0.3%)	1	0/312 (0%)	0
LEUKAEMIA	1/302 (0.3%)	1	0/312 (0%)	0
LUNG ADENOCARCINOMA	0/302 (0%)	0	1/312 (0.3%)	1
LUNG ADENOCARCINOMA METASTATIC	1/302 (0.3%)	1	0/312 (0%)	0
LUNG CANCER METASTATIC	1/302 (0.3%)	1	0/312 (0%)	0
LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV	0/302 (0%)	0	1/312 (0.3%)	1
LYMPHOMA	1/302 (0.3%)	1	0/312 (0%)	0
MULTIPLE MYELOMA	1/302 (0.3%)	1	0/312 (0%)	0
OESOPHAGEAL ADENOCARCINOMA	1/302 (0.3%)	1	0/312 (0%)	0
OESOPHAGEAL CARCINOMA	1/302 (0.3%)	1	0/312 (0%)	0
OVARIAN CANCER METASTATIC	1/302 (0.3%)	1	0/312 (0%)	0
PANCREATIC CARCINOMA	1/302 (0.3%)	1	0/312 (0%)	0
PROSTATE CANCER	0/302 (0%)	0	1/312 (0.3%)	1
RENAL CANCER	1/302 (0.3%)	1	0/312 (0%)	0
SKIN CANCER	0/302 (0%)	0	1/312 (0.3%)	1
SQUAMOUS CELL CARCINOMA	1/302 (0.3%)	1	2/312 (0.6%)	2
THYROID CANCER	0/302 (0%)	0	1/312 (0.3%)	1
TUMOUR HAEMORRHAGE	1/302 (0.3%)	1	0/312 (0%)	0
Nervous system disorders
CAROTID ARTERY DISEASE	1/302 (0.3%)	1	0/312 (0%)	0
CAROTID ARTERY STENOSIS	1/302 (0.3%)	1	1/312 (0.3%)	1
CARPAL TUNNEL SYNDROME	1/302 (0.3%)	1	0/312 (0%)	0
CEREBRAL HAEMORRHAGE	2/302 (0.7%)	2	0/312 (0%)	0
CEREBROVASCULAR ACCIDENT	12/302 (4%)	13	7/312 (2.2%)	8
CERVICOBRACHIAL SYNDROME	0/302 (0%)	0	1/312 (0.3%)	1
CONVULSION	0/302 (0%)	0	1/312 (0.3%)	1
DEMENTIA ALZHEIMER'S TYPE	0/302 (0%)	0	1/312 (0.3%)	1
DIZZINESS	2/302 (0.7%)	2	2/312 (0.6%)	2
DIZZINESS POSTURAL	1/302 (0.3%)	1	0/312 (0%)	0
DYSARTHRIA	1/302 (0.3%)	1	0/312 (0%)	0
EMBOLIC STROKE	0/302 (0%)	0	1/312 (0.3%)	1
ENCEPHALOPATHY	1/302 (0.3%)	1	4/312 (1.3%)	4
HAEMORRHAGE INTRACRANIAL	1/302 (0.3%)	1	0/312 (0%)	0
HEADACHE	0/302 (0%)	0	1/312 (0.3%)	1
HEPATIC ENCEPHALOPATHY	0/302 (0%)	0	2/312 (0.6%)	2
HYPOAESTHESIA	1/302 (0.3%)	1	0/312 (0%)	0
HYPOXIC-ISCHAEMIC ENCEPHALOPATHY	0/302 (0%)	0	1/312 (0.3%)	1
INTRACRANIAL ANEURYSM	0/302 (0%)	0	1/312 (0.3%)	1
INTRACRANIAL HYPOTENSION	1/302 (0.3%)	1	0/312 (0%)	0
ISCHAEMIC STROKE	1/302 (0.3%)	1	2/312 (0.6%)	2
LOSS OF CONSCIOUSNESS	0/302 (0%)	0	2/312 (0.6%)	2
METABOLIC ENCEPHALOPATHY	1/302 (0.3%)	1	1/312 (0.3%)	1
PARKINSON'S DISEASE	1/302 (0.3%)	1	1/312 (0.3%)	1
PRESYNCOPE	2/302 (0.7%)	2	0/312 (0%)	0
SCIATICA	1/302 (0.3%)	1	0/312 (0%)	0
SUBARACHNOID HAEMORRHAGE	3/302 (1%)	3	2/312 (0.6%)	2
SYNCOPE	10/302 (3.3%)	12	17/312 (5.4%)	18
TOXIC ENCEPHALOPATHY	1/302 (0.3%)	1	1/312 (0.3%)	1
TRANSIENT ISCHAEMIC ATTACK	2/302 (0.7%)	2	4/312 (1.3%)	4
VERTEBRAL ARTERY OCCLUSION	0/302 (0%)	0	1/312 (0.3%)	1
Psychiatric disorders
CONFUSIONAL STATE	2/302 (0.7%)	2	2/312 (0.6%)	2
DELIRIUM	1/302 (0.3%)	1	0/312 (0%)	0
DISORIENTATION	0/302 (0%)	0	1/312 (0.3%)	1
MENTAL STATUS CHANGES	8/302 (2.6%)	8	3/312 (1%)	4
PANIC ATTACK	1/302 (0.3%)	1	0/312 (0%)	0
Renal and urinary disorders
AZOTAEMIA	1/302 (0.3%)	1	3/312 (1%)	5
DYSURIA	0/302 (0%)	0	1/312 (0.3%)	1
HAEMATURIA	4/302 (1.3%)	5	1/312 (0.3%)	1
NEPHROLITHIASIS	2/302 (0.7%)	2	1/312 (0.3%)	1
NEPHROPATHY	0/302 (0%)	0	1/312 (0.3%)	1
RENAL FAILURE	6/302 (2%)	6	7/312 (2.2%)	7
RENAL FAILURE ACUTE	26/302 (8.6%)	32	39/312 (12.5%)	44
RENAL FAILURE CHRONIC	9/302 (3%)	10	16/312 (5.1%)	16
RENAL IMPAIRMENT	2/302 (0.7%)	2	0/312 (0%)	0
RENAL MASS	0/302 (0%)	0	1/312 (0.3%)	1
URINARY RETENTION	4/302 (1.3%)	4	0/312 (0%)	0
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA	0/302 (0%)	0	1/312 (0.3%)	1
VAGINAL HAEMORRHAGE	0/302 (0%)	0	1/312 (0.3%)	1
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA	2/302 (0.7%)	3	3/312 (1%)	4
ACUTE RESPIRATORY DISTRESS SYNDROME	1/302 (0.3%)	1	0/312 (0%)	0
ACUTE RESPIRATORY FAILURE	8/302 (2.6%)	9	10/312 (3.2%)	10
ASTHMA	2/302 (0.7%)	2	0/312 (0%)	0
ATELECTASIS	1/302 (0.3%)	1	1/312 (0.3%)	1
BRONCHIAL SECRETION RETENTION	0/302 (0%)	0	1/312 (0.3%)	1
CHRONIC OBSTRUCTIVE PULMONARY DISORDER	9/302 (3%)	14	7/312 (2.2%)	10
COUGH	1/302 (0.3%)	1	0/312 (0%)	0
DYSPHONIA	1/302 (0.3%)	1	0/312 (0%)	0
DYSPNOEA	17/302 (5.6%)	22	12/312 (3.8%)	13
DYSPNOEA EXERTIONAL	3/302 (1%)	3	1/312 (0.3%)	1
EPISTAXIS	4/302 (1.3%)	5	0/312 (0%)	0
HAEMOPTYSIS	0/302 (0%)	0	3/312 (1%)	3
HAEMOTHORAX	1/302 (0.3%)	1	0/312 (0%)	0
HYPERCAPNIA	1/302 (0.3%)	1	1/312 (0.3%)	1
HYPOXIA	1/302 (0.3%)	1	1/312 (0.3%)	1
INCREASED UPPER AIRWAY SECRETION	1/302 (0.3%)	1	0/312 (0%)	0
LARYNGEAL HAEMATOMA	1/302 (0.3%)	1	0/312 (0%)	0
MEDIASTINAL HAEMORRHAGE	1/302 (0.3%)	1	0/312 (0%)	0
PLEURAL EFFUSION	6/302 (2%)	7	12/312 (3.8%)	15
PNEUMONIA ASPIRATION	4/302 (1.3%)	4	5/312 (1.6%)	5
PNEUMONITIS	1/302 (0.3%)	1	1/312 (0.3%)	1
PNEUMOTHORAX	0/302 (0%)	0	1/312 (0.3%)	1
PULMONARY CONGESTION	0/302 (0%)	0	1/312 (0.3%)	1
PULMONARY FIBROSIS	1/302 (0.3%)	1	0/312 (0%)	0
PULMONARY HYPERTENSION	3/302 (1%)	3	5/312 (1.6%)	5
PULMONARY OEDEMA	1/302 (0.3%)	1	1/312 (0.3%)	1
RALES	1/302 (0.3%)	2	1/312 (0.3%)	2
RESPIRATORY DISTRESS	1/302 (0.3%)	1	1/312 (0.3%)	1
RESPIRATORY FAILURE	11/302 (3.6%)	11	16/312 (5.1%)	16
SLEEP APNOEA SYNDROME	0/302 (0%)	0	1/312 (0.3%)	1
Skin and subcutaneous tissue disorders
ANGIOEDEMA	2/302 (0.7%)	2	0/312 (0%)	0
DIGITAL ULCER	0/302 (0%)	0	1/312 (0.3%)	1
RASH	2/302 (0.7%)	2	0/312 (0%)	0
SKIN DISCOLOURATION	0/302 (0%)	0	1/312 (0.3%)	1
SKIN ULCER	0/302 (0%)	0	2/312 (0.6%)	2
Surgical and medical procedures
AORTIC SURGERY	1/302 (0.3%)	1	0/312 (0%)	0
CARDIAC PACEMAKER BATTERY REPLACEMENT	1/302 (0.3%)	1	0/312 (0%)	0
CARDIAC PACEMAKER REPLACEMENT	1/302 (0.3%)	1	0/312 (0%)	0
CAROTID ENDARTERECTOMY	1/302 (0.3%)	1	0/312 (0%)	0
CHOLECYSTECTOMY	1/302 (0.3%)	1	0/312 (0%)	0
GASTRECTOMY	1/302 (0.3%)	1	0/312 (0%)	0
HEART TRANSPLANT	0/302 (0%)	0	1/312 (0.3%)	1
HIP ARTHROPLASTY	0/302 (0%)	0	1/312 (0.3%)	1
IMPLANTABLE DEFIBRILLATOR INSERTION	1/302 (0.3%)	1	0/312 (0%)	0
IMPLANTABLE DEFIBRILLATOR REPLACEMENT	1/302 (0.3%)	1	0/312 (0%)	0
INGUINAL HERNIA REPAIR	0/302 (0%)	0	1/312 (0.3%)	1
MEDICAL DEVICE CHANGE	1/302 (0.3%)	1	0/312 (0%)	0
MITRAL VALVE REPAIR	0/302 (0%)	0	2/312 (0.6%)	2
PERCUTANEOUS CORONARY INTERVENTION	1/302 (0.3%)	1	0/312 (0%)	0
SPINAL FUSION SURGERY	2/302 (0.7%)	2	0/312 (0%)	0
Vascular disorders
ANGIOPATHY	0/302 (0%)	0	1/312 (0.3%)	1
AORTIC ANEURYSM	2/302 (0.7%)	2	2/312 (0.6%)	2
AORTIC STENOSIS	2/302 (0.7%)	2	0/312 (0%)	0
ARTERIOSCLEROSIS	2/302 (0.7%)	2	2/312 (0.6%)	2
DEEP VEIN THROMBOSIS	0/302 (0%)	0	1/312 (0.3%)	1
FEMORAL ARTERIAL STENOSIS	1/302 (0.3%)	1	0/312 (0%)	0
HAEMATOMA	3/302 (1%)	3	1/312 (0.3%)	1
HAEMODYNAMIC INSTABILITY	0/302 (0%)	0	1/312 (0.3%)	1
HAEMORRHAGE	1/302 (0.3%)	1	0/312 (0%)	0
HYPOTENSION	16/302 (5.3%)	18	13/312 (4.2%)	13
HYPOVOLAEMIC SHOCK	1/302 (0.3%)	1	1/312 (0.3%)	1
ILIAC ARTERY STENOSIS	0/302 (0%)	0	1/312 (0.3%)	1
INTERMITTENT CLAUDICATION	1/302 (0.3%)	2	1/312 (0.3%)	1
ORTHOSTATIC HYPOTENSION	0/302 (0%)	0	1/312 (0.3%)	1
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	1/302 (0.3%)	1	2/312 (0.6%)	2
PERIPHERAL ARTERY ANEURYSM	1/302 (0.3%)	1	0/312 (0%)	0
PERIPHERAL ISCHAEMIA	3/302 (1%)	3	2/312 (0.6%)	2
PERIPHERAL VASCULAR DISORDER	1/302 (0.3%)	1	1/312 (0.3%)	1
SHOCK	2/302 (0.7%)	2	1/312 (0.3%)	1
SHOCK HAEMORRHAGIC	0/302 (0%)	0	1/312 (0.3%)	1
Other (Not Including Serious) Adverse Events
	MitraClip System		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	222/302 (73.5%)		219/312 (70.2%)
Blood and lymphatic system disorders
ANAEMIA	16/302 (5.3%)	16	18/312 (5.8%)	19
ANAEMIA FOLATE DEFICIENCY	0/302 (0%)	0	1/312 (0.3%)	1
ANAEMIA MACROCYTIC	1/302 (0.3%)	1	0/312 (0%)	0
ANAEMIA OF CHRONIC DISEASE	1/302 (0.3%)	1	1/312 (0.3%)	1
COAGULOPATHY	2/302 (0.7%)	2	0/312 (0%)	0
HAEMORRHAGIC ANAEMIA	2/302 (0.7%)	2	1/312 (0.3%)	1
IRON DEFICIENCY ANAEMIA	1/302 (0.3%)	1	0/312 (0%)	0
LEUKOCYTOSIS	3/302 (1%)	4	3/312 (1%)	3
LYMPHADENOPATHY MEDIASTINAL	0/302 (0%)	0	2/312 (0.6%)	2
MACROCYTOSIS	0/302 (0%)	0	1/312 (0.3%)	1
MICROCYTIC ANAEMIA	1/302 (0.3%)	1	0/312 (0%)	0
NEPHROGENIC ANAEMIA	0/302 (0%)	0	1/312 (0.3%)	1
NORMOCHROMIC NORMOCYTIC ANAEMIA	1/302 (0.3%)	1	1/312 (0.3%)	1
PANCYTOPENIA	2/302 (0.7%)	2	0/312 (0%)	0
SPLENIC INFARCTION	1/302 (0.3%)	1	0/312 (0%)	0
SPLENOMEGALY	1/302 (0.3%)	1	1/312 (0.3%)	1
THROMBOCYTOPENIA	7/302 (2.3%)	9	4/312 (1.3%)	4
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION	2/302 (0.7%)	2	1/312 (0.3%)	1
ANGINA PECTORIS	2/302 (0.7%)	2	3/312 (1%)	3
ANGINA UNSTABLE	0/302 (0%)	0	1/312 (0.3%)	1
ARRHYTHMIA	3/302 (1%)	3	2/312 (0.6%)	2
ATRIAL FIBRILLATION	21/302 (7%)	25	12/312 (3.8%)	15
ATRIAL FLUTTER	1/302 (0.3%)	3	2/312 (0.6%)	2
ATRIAL SEPTAL DEFECT ACQUIRED	1/302 (0.3%)	1	0/312 (0%)	0
ATRIAL TACHYCARDIA	2/302 (0.7%)	2	0/312 (0%)	0
ATRIAL THROMBOSIS	1/302 (0.3%)	1	1/312 (0.3%)	1
BRADYCARDIA	3/302 (1%)	3	2/312 (0.6%)	2
CARDIAC ARREST	1/302 (0.3%)	1	0/312 (0%)	0
CARDIAC FAILURE	2/302 (0.7%)	2	9/312 (2.9%)	10
CARDIAC FAILURE ACUTE	1/302 (0.3%)	1	3/312 (1%)	4
CARDIAC FAILURE CHRONIC	7/302 (2.3%)	7	9/312 (2.9%)	9
CARDIAC FAILURE CONGESTIVE	12/302 (4%)	12	16/312 (5.1%)	22
CARDIOGENIC SHOCK	0/302 (0%)	0	1/312 (0.3%)	1
CYANOSIS	0/302 (0%)	0	1/312 (0.3%)	1
INTRACARDIAC THROMBUS	5/302 (1.7%)	5	0/312 (0%)	0
ISCHAEMIC CARDIOMYOPATHY	1/302 (0.3%)	1	0/312 (0%)	0
LEFT VENTRICULAR DYSFUNCTION	1/302 (0.3%)	1	0/312 (0%)	0
MITRAL VALVE INCOMPETENCE	7/302 (2.3%)	9	1/312 (0.3%)	1
MITRAL VALVE STENOSIS	4/302 (1.3%)	4	1/312 (0.3%)	1
PALPITATIONS	4/302 (1.3%)	4	3/312 (1%)	3
PERICARDIAL EFFUSION	4/302 (1.3%)	4	1/312 (0.3%)	1
RIGHT VENTRICULAR FAILURE	1/302 (0.3%)	1	1/312 (0.3%)	1
SICK SINUS SYNDROME	0/302 (0%)	0	1/312 (0.3%)	1
SINUS TACHYCARDIA	2/302 (0.7%)	2	1/312 (0.3%)	1
SUPRAVENTRICULAR TACHYCARDIA	1/302 (0.3%)	1	0/312 (0%)	0
TACHYCARDIA	1/302 (0.3%)	1	3/312 (1%)	3
TRICUSPID VALVE INCOMPETENCE	2/302 (0.7%)	2	0/312 (0%)	0
VENTRICULAR ARRHYTHMIA	0/302 (0%)	0	1/312 (0.3%)	1
VENTRICULAR FIBRILLATION	1/302 (0.3%)	1	2/312 (0.6%)	2
VENTRICULAR TACHYCARDIA	16/302 (5.3%)	18	7/312 (2.2%)	7
Congenital, familial and genetic disorders
ATRIAL SEPTAL DEFECT	1/302 (0.3%)	1	0/312 (0%)	0
Ear and labyrinth disorders
DEAFNESS	1/302 (0.3%)	1	0/312 (0%)	0
DEAFNESS NEUROSENSORY	0/302 (0%)	0	1/312 (0.3%)	1
DEAFNESS UNILATERAL	0/302 (0%)	0	1/312 (0.3%)	1
EAR DISORDER	0/302 (0%)	0	1/312 (0.3%)	1
EAR HAEMORRHAGE	1/302 (0.3%)	1	1/312 (0.3%)	1
VERTIGO	1/302 (0.3%)	1	0/312 (0%)	0
Endocrine disorders
HYPERPARATHYROIDISM	0/302 (0%)	0	1/312 (0.3%)	1
HYPERTHYROIDISM	0/302 (0%)	0	1/312 (0.3%)	1
HYPOTHYROIDISM	3/302 (1%)	4	2/312 (0.6%)	2
THYROIDITIS	1/302 (0.3%)	1	0/312 (0%)	0
Eye disorders
BLEPHARITIS	2/302 (0.7%)	2	0/312 (0%)	0
CATARACT	1/302 (0.3%)	1	3/312 (1%)	5
CONJUNCTIVAL HAEMORRHAGE	0/302 (0%)	0	1/312 (0.3%)	1
DIPLOPIA	1/302 (0.3%)	1	0/312 (0%)	0
EYE HAEMORRHAGE	1/302 (0.3%)	1	0/312 (0%)	0
EYE PAIN	0/302 (0%)	0	1/312 (0.3%)	1
EYELID PTOSIS	0/302 (0%)	0	1/312 (0.3%)	1
RETINAL VASCULAR OCCLUSION	1/302 (0.3%)	1	0/312 (0%)	0
VISION BLURRED	2/302 (0.7%)	2	1/312 (0.3%)	1
Gastrointestinal disorders
ABDOMINAL DISCOMFORT	1/302 (0.3%)	1	0/312 (0%)	0
ABDOMINAL DISTENSION	4/302 (1.3%)	4	1/312 (0.3%)	1
ABDOMINAL MASS	1/302 (0.3%)	1	0/312 (0%)	0
ABDOMINAL PAIN	6/302 (2%)	7	4/312 (1.3%)	5
ABDOMINAL PAIN LOWER	1/302 (0.3%)	1	0/312 (0%)	0
ABDOMINAL PAIN UPPER	3/302 (1%)	3	3/312 (1%)	4
ASCITES	5/302 (1.7%)	5	2/312 (0.6%)	2
COLITIS	0/302 (0%)	0	1/312 (0.3%)	1
CONSTIPATION	3/302 (1%)	3	7/312 (2.2%)	7
DENTAL CARIES	0/302 (0%)	0	1/312 (0.3%)	1
DIVERTICULUM INTESTINAL	1/302 (0.3%)	1	1/312 (0.3%)	1
DIVERTICULUM INTESTINAL HAEMORRHAGIC	1/302 (0.3%)	1	0/312 (0%)	0
DRY MOUTH	0/302 (0%)	0	1/312 (0.3%)	1
DUODENAL ULCER	0/302 (0%)	0	1/312 (0.3%)	1
DYSPHAGIA	3/302 (1%)	3	2/312 (0.6%)	2
FAECAL INCONTINENCE	0/302 (0%)	0	1/312 (0.3%)	1
GASTRIC POLYPS	1/302 (0.3%)	1	0/312 (0%)	0
GASTRIC ULCER	0/302 (0%)	0	1/312 (0.3%)	1
GASTRITIS	1/302 (0.3%)	1	1/312 (0.3%)	1
GASTROINTESTINAL HAEMORRHAGE	1/302 (0.3%)	1	3/312 (1%)	3
GASTROOESOPHAGEAL REFLUX DISEASE	1/302 (0.3%)	1	0/312 (0%)	0
GINGIVAL BLEEDING	1/302 (0.3%)	1	1/312 (0.3%)	1
HAEMATEMESIS	2/302 (0.7%)	2	1/312 (0.3%)	1
HAEMATOCHEZIA	1/302 (0.3%)	1	1/312 (0.3%)	1
HAEMORRHOIDAL HAEMORRHAGE	1/302 (0.3%)	1	1/312 (0.3%)	1
HAEMORRHOIDS	1/302 (0.3%)	1	2/312 (0.6%)	2
ILEUS	0/302 (0%)	0	1/312 (0.3%)	1
IMPAIRED GASTRIC EMPTYING	0/302 (0%)	0	1/312 (0.3%)	1
INGUINAL HERNIA	1/302 (0.3%)	2	1/312 (0.3%)	1
INGUINAL HERNIA, OBSTRUCTIVE	0/302 (0%)	0	1/312 (0.3%)	1
INTESTINAL MASS	0/302 (0%)	0	1/312 (0.3%)	1
MELAENA	1/302 (0.3%)	1	0/312 (0%)	0
MOUTH HAEMORRHAGE	3/302 (1%)	3	0/312 (0%)	0
NAUSEA	6/302 (2%)	7	6/312 (1.9%)	7
ODYNOPHAGIA	1/302 (0.3%)	1	0/312 (0%)	0
OESOPHAGEAL HYPOMOTILITY	0/302 (0%)	0	1/312 (0.3%)	1
PAROTID GLAND INFLAMMATION	0/302 (0%)	0	1/312 (0.3%)	1
POOR DENTAL CONDITION	1/302 (0.3%)	1	0/312 (0%)	0
PROCTALGIA	1/302 (0.3%)	1	0/312 (0%)	0
RECTAL HAEMORRHAGE	1/302 (0.3%)	1	3/312 (1%)	3
SALIVARY GLAND DISORDER	1/302 (0.3%)	1	0/312 (0%)	0
TONGUE ULCERATION	0/302 (0%)	0	1/312 (0.3%)	1
TOOTHACHE	1/302 (0.3%)	1	0/312 (0%)	0
VOMITING	5/302 (1.7%)	5	13/312 (4.2%)	14
General disorders
ADVERSE DRUG REACTION	10/302 (3.3%)	10	10/312 (3.2%)	11
APPLICATION SITE PAIN	0/302 (0%)	0	1/312 (0.3%)	1
ASTHENIA	5/302 (1.7%)	6	6/312 (1.9%)	6
CATHETER SITE DISCHARGE	1/302 (0.3%)	1	0/312 (0%)	0
CATHETER SITE HAEMATOMA	3/302 (1%)	3	0/312 (0%)	0
CATHETER SITE HAEMORRHAGE	15/302 (5%)	15	3/312 (1%)	3
CATHETER SITE INFLAMMATION	1/302 (0.3%)	1	0/312 (0%)	0
CATHETER SITE PAIN	2/302 (0.7%)	2	1/312 (0.3%)	1
CHEST DISCOMFORT	4/302 (1.3%)	5	1/312 (0.3%)	1
CHEST PAIN	9/302 (3%)	13	13/312 (4.2%)	15
CYST	0/302 (0%)	0	1/312 (0.3%)	1
DEVICE BATTERY ISSUE	0/302 (0%)	0	1/312 (0.3%)	1
DEVICE CAPTURING ISSUE	0/302 (0%)	0	1/312 (0.3%)	1
DEVICE DISLOCATION	1/302 (0.3%)	1	0/312 (0%)	0
DEVICE ELECTRICAL FINDING	1/302 (0.3%)	1	2/312 (0.6%)	2
DEVICE INFUSION ISSUE	0/302 (0%)	0	1/312 (0.3%)	1
DEVICE ISSUE	0/302 (0%)	0	1/312 (0.3%)	1
DEVICE LEAD DAMAGE	1/302 (0.3%)	1	0/312 (0%)	0
DEVICE MALFUNCTION	0/302 (0%)	0	1/312 (0.3%)	1
DEVICE STIMULATION ISSUE	0/302 (0%)	0	1/312 (0.3%)	1
EXERCISE TOLERANCE DECREASED	1/302 (0.3%)	1	0/312 (0%)	0
FATIGUE	8/302 (2.6%)	11	9/312 (2.9%)	9
GENERALISED OEDEMA	1/302 (0.3%)	1	0/312 (0%)	0
HYPOTHERMIA	0/302 (0%)	0	1/312 (0.3%)	1
INFUSION SITE HAEMATOMA	1/302 (0.3%)	1	0/312 (0%)	0
INJECTION SITE HAEMATOMA	1/302 (0.3%)	1	0/312 (0%)	0
INJECTION SITE HAEMORRHAGE	0/302 (0%)	0	1/312 (0.3%)	1
MALAISE	1/302 (0.3%)	1	1/312 (0.3%)	1
MEDICAL DEVICE COMPLICATION	0/302 (0%)	0	2/312 (0.6%)	2
MUCOSAL HAEMORRHAGE	1/302 (0.3%)	1	0/312 (0%)	0
NON-CARDIAC CHEST PAIN	3/302 (1%)	4	8/312 (2.6%)	8
OEDEMA	4/302 (1.3%)	4	3/312 (1%)	3
OEDEMA PERIPHERAL	12/302 (4%)	13	12/312 (3.8%)	17
PELVIC MASS	0/302 (0%)	0	1/312 (0.3%)	1
PYREXIA	5/302 (1.7%)	5	2/312 (0.6%)	2
SWELLING	1/302 (0.3%)	1	0/312 (0%)	0
ULCER	1/302 (0.3%)	1	0/312 (0%)	0
VESSEL PUNCTURE SITE HAEMATOMA	1/302 (0.3%)	1	0/312 (0%)	0
VESSEL PUNCTURE SITE HAEMORRHAGE	2/302 (0.7%)	2	0/312 (0%)	0
Hepatobiliary disorders
CHOLECYSTITIS	1/302 (0.3%)	1	1/312 (0.3%)	1
CHOLELITHIASIS	1/302 (0.3%)	1	1/312 (0.3%)	1
HEPATIC CIRRHOSIS	1/302 (0.3%)	1	1/312 (0.3%)	1
HEPATIC CONGESTION	1/302 (0.3%)	1	2/312 (0.6%)	2
HEPATOMEGALY	0/302 (0%)	0	1/312 (0.3%)	1
HYPERBILIRUBINAEMIA	1/302 (0.3%)	1	2/312 (0.6%)	2
LIVER DISORDER	0/302 (0%)	0	1/312 (0.3%)	1
Immune system disorders
DRUG HYPERSENSITIVITY	0/302 (0%)	0	1/312 (0.3%)	1
SEASONAL ALLERGY	0/302 (0%)	0	1/312 (0.3%)	1
Infections and infestations
ACUTE SINUSITIS	1/302 (0.3%)	1	2/312 (0.6%)	2
ASYMPTOMATIC BACTERIURIA	0/302 (0%)	0	1/312 (0.3%)	1
BACTERAEMIA	1/302 (0.3%)	1	0/312 (0%)	0
BRONCHITIS	7/302 (2.3%)	8	4/312 (1.3%)	5
CANDIDIASIS	1/302 (0.3%)	1	2/312 (0.6%)	2
CATHETER SITE INFECTION	1/302 (0.3%)	1	0/312 (0%)	0
CELLULITIS	4/302 (1.3%)	6	5/312 (1.6%)	5
CLOSTRIDIAL INFECTION	1/302 (0.3%)	1	1/312 (0.3%)	1
CLOSTRIDIUM DIFFICILE COLITIS	4/302 (1.3%)	4	2/312 (0.6%)	2
CYSTITIS KLEBSIELLA	1/302 (0.3%)	1	0/312 (0%)	0
DEVICE RELATED INFECTION	1/302 (0.3%)	1	0/312 (0%)	0
DIVERTICULITIS	1/302 (0.3%)	1	2/312 (0.6%)	2
EAR INFECTION	2/302 (0.7%)	2	1/312 (0.3%)	1
ENDOCARDITIS ENTEROCOCCAL	1/302 (0.3%)	1	0/312 (0%)	0
ENTEROCOCCAL BACTERAEMIA	1/302 (0.3%)	1	0/312 (0%)	0
ESCHERICHIA URINARY TRACT INFECTION	0/302 (0%)	0	1/312 (0.3%)	1
GASTROENTERITIS	0/302 (0%)	0	2/312 (0.6%)	2
HERPES ZOSTER	2/302 (0.7%)	2	3/312 (1%)	3
INCISION SITE ABSCESS	0/302 (0%)	0	1/312 (0.3%)	1
INFECTED BITES	0/302 (0%)	0	1/312 (0.3%)	1
INFLUENZA	4/302 (1.3%)	4	1/312 (0.3%)	1
INTERVERTEBRAL DISCITIS	1/302 (0.3%)	1	0/312 (0%)	0
LOBAR PNEUMONIA	0/302 (0%)	0	1/312 (0.3%)	1
LOCALISED INFECTION	2/302 (0.7%)	2	0/312 (0%)	0
NASOPHARYNGITIS	1/302 (0.3%)	1	1/312 (0.3%)	1
ONYCHOMYCOSIS	1/302 (0.3%)	1	0/312 (0%)	0
ORAL CANDIDIASIS	0/302 (0%)	0	2/312 (0.6%)	2
ORAL HERPES	1/302 (0.3%)	1	0/312 (0%)	0
OTITIS MEDIA	0/302 (0%)	0	2/312 (0.6%)	2
OTITIS MEDIA ACUTE	0/302 (0%)	0	1/312 (0.3%)	1
PERITONITIS	1/302 (0.3%)	1	0/312 (0%)	0
PHARYNGITIS	1/302 (0.3%)	1	0/312 (0%)	0
PNEUMONIA	10/302 (3.3%)	11	12/312 (3.8%)	13
RESPIRATORY TRACT INFECTION VIRAL	0/302 (0%)	0	2/312 (0.6%)	2
RHINITIS	0/302 (0%)	0	2/312 (0.6%)	2
RHINOVIRUS INFECTION	0/302 (0%)	0	1/312 (0.3%)	1
SEPSIS	0/302 (0%)	0	2/312 (0.6%)	2
SEPTIC SHOCK	1/302 (0.3%)	1	0/312 (0%)	0
SINUSITIS	2/302 (0.7%)	2	3/312 (1%)	3
STAPHYLOCOCCAL BACTERAEMIA	1/302 (0.3%)	1	0/312 (0%)	0
STAPHYLOCOCCAL SEPSIS	0/302 (0%)	0	1/312 (0.3%)	1
TOOTH INFECTION	1/302 (0.3%)	1	0/312 (0%)	0
UPPER RESPIRATORY TRACT INFECTION	7/302 (2.3%)	9	7/312 (2.2%)	7
URINARY TRACT INFECTION	20/302 (6.6%)	29	15/312 (4.8%)	15
URINARY TRACT INFECTION BACTERIAL	0/302 (0%)	0	1/312 (0.3%)	1
URINARY TRACT INFECTION ENTEROCOCCAL	2/302 (0.7%)	2	0/312 (0%)	0
UROSEPSIS	2/302 (0.7%)	2	0/312 (0%)	0
VIRAEMIA	1/302 (0.3%)	1	0/312 (0%)	0
VIRAL INFECTION	1/302 (0.3%)	1	2/312 (0.6%)	2
VIRAL UPPER RESPIRATORY TRACT INFECTION	2/302 (0.7%)	2	0/312 (0%)	0
Injury, poisoning and procedural complications
AGITATION POSTOPERATIVE	1/302 (0.3%)	1	0/312 (0%)	0
ANAEMIA POSTOPERATIVE	3/302 (1%)	3	0/312 (0%)	0
ANIMAL BITE	0/302 (0%)	0	1/312 (0.3%)	1
ANKLE FRACTURE	0/302 (0%)	0	1/312 (0.3%)	1
CARDIAC PROCEDURE COMPLICATION	2/302 (0.7%)	2	0/312 (0%)	0
CATHETER SITE HAEMATOMA	6/302 (2%)	6	1/312 (0.3%)	1
CERVICAL VERTEBRAL FRACTURE	0/302 (0%)	0	1/312 (0.3%)	1
CONTUSION	4/302 (1.3%)	4	4/312 (1.3%)	4
CRANIOCEREBRAL INJURY	0/302 (0%)	0	1/312 (0.3%)	1
EAR ABRASION	0/302 (0%)	0	1/312 (0.3%)	1
EAR INJURY	1/302 (0.3%)	1	0/312 (0%)	0
ENDOTRACHEAL INTUBATION COMPLICATION	1/302 (0.3%)	1	0/312 (0%)	0
EXCORIATION	1/302 (0.3%)	1	3/312 (1%)	3
FACE INJURY	0/302 (0%)	0	1/312 (0.3%)	1
FALL	14/302 (4.6%)	14	20/312 (6.4%)	23
FEMUR FRACTURE	1/302 (0.3%)	1	0/312 (0%)	0
FOOT FRACTURE	1/302 (0.3%)	1	0/312 (0%)	0
FOREARM FRACTURE	1/302 (0.3%)	1	0/312 (0%)	0
FROSTBITE	1/302 (0.3%)	1	0/312 (0%)	0
HAEMATURIA TRAUMATIC	1/302 (0.3%)	1	0/312 (0%)	0
HAND FRACTURE	0/302 (0%)	0	1/312 (0.3%)	1
HEAD INJURY	0/302 (0%)	0	3/312 (1%)	3
HUMERUS FRACTURE	0/302 (0%)	0	2/312 (0.6%)	2
IN-STENT CORONARY ARTERY RESTENOSIS	0/302 (0%)	0	1/312 (0.3%)	1
INJURY	0/302 (0%)	0	1/312 (0.3%)	1
INTENTIONAL OVERDOSE	1/302 (0.3%)	1	0/312 (0%)	0
INTERVERTEBRAL DISC INJURY	0/302 (0%)	0	1/312 (0.3%)	1
JAW FRACTURE	0/302 (0%)	0	1/312 (0.3%)	1
JOINT INJURY	1/302 (0.3%)	1	4/312 (1.3%)	4
LACERATION	11/302 (3.6%)	12	6/312 (1.9%)	6
LIGAMENT SPRAIN	0/302 (0%)	0	2/312 (0.6%)	2
LIMB INJURY	1/302 (0.3%)	1	0/312 (0%)	0
LUMBAR VERTEBRAL FRACTURE	2/302 (0.7%)	2	1/312 (0.3%)	1
MULTIPLE FRACTURES	0/302 (0%)	0	1/312 (0.3%)	1
MUSCLE STRAIN	0/302 (0%)	0	1/312 (0.3%)	1
OPEN WOUND	1/302 (0.3%)	1	0/312 (0%)	0
PERIORBITAL HAEMATOMA	1/302 (0.3%)	1	0/312 (0%)	0
POST PROCEDURAL DIARRHOEA	0/302 (0%)	0	1/312 (0.3%)	1
POST PROCEDURAL HAEMATURIA	1/302 (0.3%)	1	0/312 (0%)	0
POST PROCEDURAL HAEMORRHAGE	1/302 (0.3%)	1	1/312 (0.3%)	1
POST PROCEDURAL HYPOTHYROIDISM	0/302 (0%)	0	1/312 (0.3%)	1
POST PROCEDURAL SWELLING	1/302 (0.3%)	1	0/312 (0%)	0
POST-TRAUMATIC PAIN	1/302 (0.3%)	1	3/312 (1%)	3
PROCEDURAL COMPLICATION	3/302 (1%)	3	0/312 (0%)	0
PROCEDURAL DIZZINESS	0/302 (0%)	0	1/312 (0.3%)	1
PROCEDURAL HAEMORRHAGE	2/302 (0.7%)	2	0/312 (0%)	0
PROCEDURAL HEADACHE	3/302 (1%)	3	0/312 (0%)	0
PROCEDURAL HYPOTENSION	6/302 (2%)	6	0/312 (0%)	0
PROCEDURAL NAUSEA	3/302 (1%)	3	0/312 (0%)	0
RIB FRACTURE	0/302 (0%)	0	2/312 (0.6%)	2
SKELETAL INJURY	1/302 (0.3%)	1	0/312 (0%)	0
SKIN WOUND	0/302 (0%)	0	1/312 (0.3%)	1
SUBCUTANEOUS HAEMATOMA	1/302 (0.3%)	1	0/312 (0%)	0
THERMAL BURN	1/302 (0.3%)	1	0/312 (0%)	0
TOXICITY TO VARIOUS AGENTS	0/302 (0%)	0	1/312 (0.3%)	1
TRAUMATIC HAEMATOMA	1/302 (0.3%)	1	1/312 (0.3%)	1
TRAUMATIC HAEMORRHAGE	1/302 (0.3%)	1	0/312 (0%)	0
TRAUMATIC INTRACRANIAL HAEMORRHAGE	1/302 (0.3%)	1	0/312 (0%)	0
TRAUMATIC LUNG INJURY	0/302 (0%)	0	1/312 (0.3%)	1
UPPER LIMB FRACTURE	1/302 (0.3%)	1	0/312 (0%)	0
URETHRAL INJURY	0/302 (0%)	0	1/312 (0.3%)	1
URINARY RETENTION POSTOPERATIVE	1/302 (0.3%)	1	0/312 (0%)	0
VASCULAR GRAFT OCCLUSION	0/302 (0%)	0	1/312 (0.3%)	1
WRIST FRACTURE	1/302 (0.3%)	1	1/312 (0.3%)	1
Investigations
ALANINE AMINOTRANSFERASE INCREASED	0/302 (0%)	0	1/312 (0.3%)	1
AMYLASE INCREASED	0/302 (0%)	0	1/312 (0.3%)	1
ANTIBIOTIC RESISTANT STAPHYLOCOCCUS TEST POSITIVE	2/302 (0.7%)	3	0/312 (0%)	0
ANTICOAGULATION DRUG LEVEL ABOVE THERAPEUTIC	2/302 (0.7%)	3	0/312 (0%)	0
ANTICOAGULATION DRUG LEVEL BELOW THERAPEUTIC	0/302 (0%)	0	1/312 (0.3%)	1
BLOOD ALKALINE PHOSPHATASE INCREASED	1/302 (0.3%)	1	2/312 (0.6%)	2
BLOOD CREATINE PHOSPHOKINASE INCREASED	8/302 (2.6%)	8	4/312 (1.3%)	4
BLOOD CREATINE MB PHOSPHOKINASE INCREASED	7/302 (2.3%)	7	8/312 (2.6%)	11
BLOOD CREATININE INCREASED	6/302 (2%)	6	6/312 (1.9%)	7
BLOOD GLUCOSE INCREASED	1/302 (0.3%)	1	0/312 (0%)	0
BLOOD POTASSIUM DECREASED	1/302 (0.3%)	1	0/312 (0%)	0
BLOOD POTASSIUM INCREASED	0/302 (0%)	0	1/312 (0.3%)	1
BLOOD PRESSURE DECREASED	1/302 (0.3%)	1	0/312 (0%)	0
BLOOD THYROID STIMULATING HORMONE INCREASED	1/302 (0.3%)	1	0/312 (0%)	0
BLOOD UREA INCREASED	0/302 (0%)	0	1/312 (0.3%)	1
BRAIN NATRIURETIC PEPTIDE INCREASED	2/302 (0.7%)	2	3/312 (1%)	3
CARCINOEMBRYONIC ANTIGEN INCREASED	1/302 (0.3%)	1	0/312 (0%)	0
CARDIAC ENZYMES INCREASED	1/302 (0.3%)	2	1/312 (0.3%)	1
CARDIAC INDEX DECREASED	0/302 (0%)	0	2/312 (0.6%)	2
CARDIAC OUTPUT DECREASED	0/302 (0%)	0	1/312 (0.3%)	1
CLOSTRIDIUM TEST POSITIVE	0/302 (0%)	0	1/312 (0.3%)	1
COMPUTERISED TOMOGRAM ABDOMEN ABNORMAL	1/302 (0.3%)	1	0/312 (0%)	0
DRUG LEVEL ABOVE THERAPEUTIC	1/302 (0.3%)	1	0/312 (0%)	0
EJECTION FRACTION DECREASED	2/302 (0.7%)	2	0/312 (0%)	0
ELECTROCARDIOGRAM ABNORMAL	0/302 (0%)	0	1/312 (0.3%)	1
ELECTROCARDIOGRAM CHANGE	0/302 (0%)	0	1/312 (0.3%)	1
ELECTROCARDIOGRAM QT PROLONGED	2/302 (0.7%)	2	3/312 (1%)	3
FIBRIN D DIMER INCREASED	0/302 (0%)	0	1/312 (0.3%)	1
GAMMA-GLUTAMYLTRANSFERASE INCREASED	0/302 (0%)	0	1/312 (0.3%)	1
HAEMATOLOGY TEST ABNORMAL	1/302 (0.3%)	1	0/312 (0%)	0
HAEMOGLOBIN DECREASED	0/302 (0%)	0	1/312 (0.3%)	1
HEART RATE INCREASED	1/302 (0.3%)	1	0/312 (0%)	0
HELICOBACTER TEST POSITIVE	0/302 (0%)	0	1/312 (0.3%)	1
HEPATIC ENZYME INCREASED	1/302 (0.3%)	1	1/312 (0.3%)	1
INTERNATIONAL NORMALISED RATIO INCREASED	2/302 (0.7%)	2	4/312 (1.3%)	4
LIPASE INCREASED	0/302 (0%)	0	1/312 (0.3%)	1
LIVER FUNCTION TEST ABNORMAL	0/302 (0%)	0	4/312 (1.3%)	5
N-TERMINAL PROHORMONE BRAIN NATRIURETIC PEPTIDE INCREASED	0/302 (0%)	0	1/312 (0.3%)	1
OCCULT BLOOD POSITIVE	1/302 (0.3%)	1	0/312 (0%)	0
OXYGEN CONSUMPTION DECREASED	1/302 (0.3%)	1	0/312 (0%)	0
OXYGEN SATURATION DECREASED	0/302 (0%)	0	1/312 (0.3%)	1
PLATELET COUNT DECREASED	0/302 (0%)	0	2/312 (0.6%)	2
PROTHROMBIN TIME PROLONGED	0/302 (0%)	0	1/312 (0.3%)	1
TRANSAMINASES INCREASED	2/302 (0.7%)	2	0/312 (0%)	0
TROPONIN I INCREASED	2/302 (0.7%)	2	0/312 (0%)	0
TROPONIN INCREASED	5/302 (1.7%)	5	8/312 (2.6%)	8
ULTRASOUND ABDOMEN NORMAL	0/302 (0%)	0	1/312 (0.3%)	1
WEIGHT DECREASED	2/302 (0.7%)	2	0/312 (0%)	0
WEIGHT INCREASED	2/302 (0.7%)	2	6/312 (1.9%)	7
WHITE BLOOD CELL COUNT INCREASED	1/302 (0.3%)	1	1/312 (0.3%)	2
Metabolism and nutrition disorders
ACIDOSIS	0/302 (0%)	0	1/312 (0.3%)	1
CACHEXIA	0/302 (0%)	0	3/312 (1%)	3
DECREASED APPETITE	2/302 (0.7%)	2	0/312 (0%)	0
DEHYDRATION	3/302 (1%)	3	7/312 (2.2%)	8
DYSLIPIDAEMIA	0/302 (0%)	0	1/312 (0.3%)	1
FAILURE TO THRIVE	1/302 (0.3%)	1	1/312 (0.3%)	1
FLUID OVERLOAD	7/302 (2.3%)	8	5/312 (1.6%)	5
FLUID RETENTION	1/302 (0.3%)	1	4/312 (1.3%)	6
GOUT	10/302 (3.3%)	13	11/312 (3.5%)	15
HYPERAMMONAEMIA	0/302 (0%)	0	1/312 (0.3%)	1
HYPERCALCAEMIA	0/302 (0%)	0	1/312 (0.3%)	1
HYPERGLYCAEMIA	2/302 (0.7%)	2	3/312 (1%)	3
HYPERKALAEMIA	15/302 (5%)	16	8/312 (2.6%)	8
HYPERNATRAEMIA	4/302 (1.3%)	4	1/312 (0.3%)	1
HYPERPHOSPHATAEMIA	1/302 (0.3%)	1	0/312 (0%)	0
HYPERVOLAEMIA	2/302 (0.7%)	2	2/312 (0.6%)	2
HYPOCALCAEMIA	2/302 (0.7%)	2	1/312 (0.3%)	1
HYPOCHLORAEMIA	2/302 (0.7%)	2	0/312 (0%)	0
HYPOGLYCAEMIA	2/302 (0.7%)	2	3/312 (1%)	4
HYPOKALAEMIA	10/302 (3.3%)	13	9/312 (2.9%)	10
HYPOMAGNESAEMIA	4/302 (1.3%)	4	1/312 (0.3%)	1
HYPONATRAEMIA	5/302 (1.7%)	7	11/312 (3.5%)	11
HYPOVOLAEMIA	1/302 (0.3%)	1	3/312 (1%)	3
LACTIC ACIDOSIS	1/302 (0.3%)	1	0/312 (0%)	0
LACTOSE INTOLERANCE	1/302 (0.3%)	1	0/312 (0%)	0
MALNUTRITION	1/302 (0.3%)	1	1/312 (0.3%)	1
METABOLIC ALKALOSIS	1/302 (0.3%)	1	1/312 (0.3%)	1
TYPE 2 DIABETES MELLITUS	3/302 (1%)	3	0/312 (0%)	0
VITAMIN D DEFICIENCY	1/302 (0.3%)	1	1/312 (0.3%)	1
Musculoskeletal and connective tissue disorders
ARTHRALGIA	6/302 (2%)	7	2/312 (0.6%)	2
ARTHRITIS	1/302 (0.3%)	1	0/312 (0%)	0
BACK PAIN	4/302 (1.3%)	4	5/312 (1.6%)	5
BUNION	1/302 (0.3%)	1	0/312 (0%)	0
BURSITIS	0/302 (0%)	0	2/312 (0.6%)	2
FLANK PAIN	2/302 (0.7%)	2	1/312 (0.3%)	1
GOUTY ARTHRITIS	1/302 (0.3%)	1	1/312 (0.3%)	1
JOINT EFFUSION	1/302 (0.3%)	1	1/312 (0.3%)	1
LIMB DISCOMFORT	0/302 (0%)	0	1/312 (0.3%)	1
MOBILITY DECREASED	0/302 (0%)	0	1/312 (0.3%)	1
MUSCLE HAEMORRHAGE	1/302 (0.3%)	1	0/312 (0%)	0
MUSCLE SPASMS	1/302 (0.3%)	1	2/312 (0.6%)	2
MUSCULAR WEAKNESS	3/302 (1%)	3	1/312 (0.3%)	1
MUSCULOSKELETAL CHEST PAIN	3/302 (1%)	3	1/312 (0.3%)	1
MUSCULOSKELETAL PAIN	6/302 (2%)	6	4/312 (1.3%)	4
MYALGIA	2/302 (0.7%)	2	0/312 (0%)	0
MYOSITIS	0/302 (0%)	0	1/312 (0.3%)	1
NECK MASS	2/302 (0.7%)	2	1/312 (0.3%)	1
NECK PAIN	2/302 (0.7%)	2	2/312 (0.6%)	2
OSTEOARTHRITIS	2/302 (0.7%)	2	0/312 (0%)	0
PAIN IN EXTREMITY	8/302 (2.6%)	8	8/312 (2.6%)	8
RENAL OSTEODYSTROPHY	1/302 (0.3%)	1	0/312 (0%)	0
RHEUMATOID ARTHRITIS	0/302 (0%)	0	1/312 (0.3%)	1
ROTATOR CUFF SYNDROME	2/302 (0.7%)	2	0/312 (0%)	0
TENDONITIS	1/302 (0.3%)	1	0/312 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADRENAL ADENOMA	1/302 (0.3%)	1	0/312 (0%)	0
ANGIOSARCOMA RECURRENT	1/302 (0.3%)	1	0/312 (0%)	0
B-CELL LYMPHOMA	1/302 (0.3%)	1	0/312 (0%)	0
BASAL CELL CARCINOMA	3/302 (1%)	3	0/312 (0%)	0
BOWEN'S DISEASE	1/302 (0.3%)	1	0/312 (0%)	0
CANCER PAIN	1/302 (0.3%)	1	0/312 (0%)	0
LUNG NEOPLASM	2/302 (0.7%)	2	2/312 (0.6%)	2
MYELODYSPLASTIC SYNDROME	0/302 (0%)	0	1/312 (0.3%)	1
PARAPROTEINAEMIA	1/302 (0.3%)	1	0/312 (0%)	0
RENAL CELL CARCINOMA	1/302 (0.3%)	1	0/312 (0%)	0
SEBORRHOEIC KERATOSIS	0/302 (0%)	0	1/312 (0.3%)	1
SKIN CANCER	1/302 (0.3%)	1	0/312 (0%)	0
SQUAMOUS CELL CARCINOMA	2/302 (0.7%)	2	1/312 (0.3%)	1
Nervous system disorders
ALTERED STATE OF CONSCIOUSNESS	1/302 (0.3%)	1	0/312 (0%)	0
AMNESIA	1/302 (0.3%)	1	2/312 (0.6%)	2
BALANCE DISORDER	1/302 (0.3%)	1	0/312 (0%)	0
CARPAL TUNNEL SYNDROME	0/302 (0%)	0	1/312 (0.3%)	1
COGNITIVE DISORDER	1/302 (0.3%)	1	3/312 (1%)	3
DEMENTIA	1/302 (0.3%)	1	0/312 (0%)	0
DEMENTIA ALZHEIMER'S TYPE	1/302 (0.3%)	1	0/312 (0%)	0
DIABETIC NEUROPATHY	0/302 (0%)	0	1/312 (0.3%)	1
DIZZINESS	15/302 (5%)	17	11/312 (3.5%)	13
DIZZINESS POSTURAL	6/302 (2%)	6	3/312 (1%)	3
DYSARTHRIA	0/302 (0%)	0	1/312 (0.3%)	1
ENCEPHALOPATHY	3/302 (1%)	3	2/312 (0.6%)	2
ESSENTIAL TREMOR	0/302 (0%)	0	1/312 (0.3%)	1
GUILLAIN-BARRE SYNDROME	1/302 (0.3%)	1	0/312 (0%)	0
HEADACHE	2/302 (0.7%)	2	5/312 (1.6%)	5
HYPOAESTHESIA	4/302 (1.3%)	5	2/312 (0.6%)	2
LACUNAR INFARCTION	0/302 (0%)	0	1/312 (0.3%)	1
LOSS OF CONSCIOUSNESS	0/302 (0%)	0	1/312 (0.3%)	1
LUMBAR RADICULOPATHY	0/302 (0%)	0	2/312 (0.6%)	2
METABOLIC ENCEPHALOPATHY	2/302 (0.7%)	3	0/312 (0%)	0
MIGRAINE	1/302 (0.3%)	1	0/312 (0%)	0
MYOCLONUS	0/302 (0%)	0	1/312 (0.3%)	1
PARAESTHESIA	1/302 (0.3%)	1	0/312 (0%)	0
PARKINSON'S DISEASE	1/302 (0.3%)	1	0/312 (0%)	0
PARKINSONISM	0/302 (0%)	0	1/312 (0.3%)	1
PARTIAL SEIZURES	1/302 (0.3%)	1	0/312 (0%)	0
PHANTOM PAIN	1/302 (0.3%)	1	0/312 (0%)	0
PRESYNCOPE	3/302 (1%)	3	4/312 (1.3%)	5
RESTLESS LEGS SYNDROME	1/302 (0.3%)	1	0/312 (0%)	0
SCIATICA	0/302 (0%)	0	1/312 (0.3%)	1
SOMNOLENCE	1/302 (0.3%)	1	1/312 (0.3%)	1
SYNCOPE	7/302 (2.3%)	7	8/312 (2.6%)	9
TRANSIENT ISCHAEMIC ATTACK	0/302 (0%)	0	1/312 (0.3%)	1
TREMOR	1/302 (0.3%)	1	1/312 (0.3%)	1
VASCULAR DEMENTIA	1/302 (0.3%)	1	0/312 (0%)	0
Psychiatric disorders
ANXIETY	1/302 (0.3%)	1	2/312 (0.6%)	2
CONFUSIONAL STATE	1/302 (0.3%)	1	2/312 (0.6%)	2
DELIRIUM	2/302 (0.7%)	2	4/312 (1.3%)	5
DEPRESSION	2/302 (0.7%)	2	2/312 (0.6%)	2
HALLUCINATION	1/302 (0.3%)	1	1/312 (0.3%)	1
INSOMNIA	6/302 (2%)	6	2/312 (0.6%)	2
MAJOR DEPRESSION	0/302 (0%)	0	1/312 (0.3%)	1
MENTAL DISORDER	0/302 (0%)	0	1/312 (0.3%)	1
MENTAL STATUS CHANGES	7/302 (2.3%)	7	3/312 (1%)	3
PANIC ATTACK	1/302 (0.3%)	1	0/312 (0%)	0
STRESS	1/302 (0.3%)	1	0/312 (0%)	0
Renal and urinary disorders
BLADDER SPASM	1/302 (0.3%)	1	0/312 (0%)	0
CYSTITIS HAEMORRHAGIC	1/302 (0.3%)	1	0/312 (0%)	0
DYSURIA	4/302 (1.3%)	4	0/312 (0%)	0
HAEMATURIA	11/302 (3.6%)	11	2/312 (0.6%)	2
NEPHROLITHIASIS	0/302 (0%)	0	1/312 (0.3%)	1
NEPHROPATHY TOXIC	1/302 (0.3%)	1	0/312 (0%)	0
PYURIA	1/302 (0.3%)	1	0/312 (0%)	0
RENAL CYST	0/302 (0%)	0	1/312 (0.3%)	1
RENAL FAILURE	6/302 (2%)	6	6/312 (1.9%)	6
RENAL FAILURE ACUTE	21/302 (7%)	23	21/312 (6.7%)	31
RENAL FAILURE CHRONIC	9/302 (3%)	9	3/312 (1%)	3
RENAL IMPAIRMENT	1/302 (0.3%)	1	3/312 (1%)	4
RENAL INJURY	0/302 (0%)	0	1/312 (0.3%)	1
RENAL MASS	2/302 (0.7%)	2	1/312 (0.3%)	1
RENAL TUBULAR NECROSIS	1/302 (0.3%)	1	0/312 (0%)	0
URINARY RETENTION	7/302 (2.3%)	7	4/312 (1.3%)	4
Reproductive system and breast disorders
ACQUIRED PHIMOSIS	0/302 (0%)	0	1/312 (0.3%)	1
BENIGN PROSTATIC HYPERPLASIA	1/302 (0.3%)	1	0/312 (0%)	0
BREAST INFLAMMATION	0/302 (0%)	0	1/312 (0.3%)	1
BREAST MASS	1/302 (0.3%)	1	1/312 (0.3%)	1
BREAST PAIN	0/302 (0%)	0	1/312 (0.3%)	1
BREAST TENDERNESS	1/302 (0.3%)	1	0/312 (0%)	0
GYNAECOMASTIA	2/302 (0.7%)	2	0/312 (0%)	0
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE	1/302 (0.3%)	1	1/312 (0.3%)	1
ASTHMA	0/302 (0%)	0	1/312 (0.3%)	1
ATELECTASIS	4/302 (1.3%)	4	1/312 (0.3%)	1
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	7/302 (2.3%)	7	4/312 (1.3%)	11
COUGH	3/302 (1%)	3	9/312 (2.9%)	9
DYSPHONIA	0/302 (0%)	0	1/312 (0.3%)	1
DYSPNOEA	19/302 (6.3%)	19	23/312 (7.4%)	29
DYSPNOEA EXERTIONAL	3/302 (1%)	3	2/312 (0.6%)	2
DYSPNOEA PAROXYSMAL NOCTURNAL	1/302 (0.3%)	1	0/312 (0%)	0
EMPHYSEMA	1/302 (0.3%)	1	0/312 (0%)	0
EPISTAXIS	10/302 (3.3%)	11	9/312 (2.9%)	9
HAEMOPTYSIS	2/302 (0.7%)	2	0/312 (0%)	0
HICCUPS	1/302 (0.3%)	1	0/312 (0%)	0
HYPERCAPNIA	1/302 (0.3%)	1	0/312 (0%)	0
HYPOXIA	2/302 (0.7%)	2	2/312 (0.6%)	2
LUNG INFILTRATION	1/302 (0.3%)	1	1/312 (0.3%)	1
NASAL CONGESTION	1/302 (0.3%)	1	0/312 (0%)	0
OROPHARYNGEAL PAIN	4/302 (1.3%)	4	2/312 (0.6%)	2
ORTHOPNOEA	0/302 (0%)	0	1/312 (0.3%)	1
PAINFUL RESPIRATION	1/302 (0.3%)	1	0/312 (0%)	0
PLEURAL EFFUSION	16/302 (5.3%)	18	11/312 (3.5%)	11
PLEURITIC PAIN	1/302 (0.3%)	1	0/312 (0%)	0
PNEUMONIA ASPIRATION	2/302 (0.7%)	2	1/312 (0.3%)	1
PNEUMONITIS	2/302 (0.7%)	2	0/312 (0%)	0
PNEUMOTHORAX	2/302 (0.7%)	2	1/312 (0.3%)	1
PRODUCTIVE COUGH	4/302 (1.3%)	4	3/312 (1%)	3
PULMONARY CONGESTION	1/302 (0.3%)	1	0/312 (0%)	0
PULMONARY FIBROSIS	2/302 (0.7%)	2	0/312 (0%)	0
PULMONARY HAEMORRHAGE	1/302 (0.3%)	1	0/312 (0%)	0
PULMONARY HYPERTENSION	3/302 (1%)	3	2/312 (0.6%)	2
PULMONARY MASS	1/302 (0.3%)	1	2/312 (0.6%)	2
PULMONARY OEDEMA	1/302 (0.3%)	1	4/312 (1.3%)	5
RESPIRATORY FAILURE	1/302 (0.3%)	1	0/312 (0%)	0
RHINITIS ALLERGIC	1/302 (0.3%)	1	0/312 (0%)	0
WHEEZING	1/302 (0.3%)	1	0/312 (0%)	0
Skin and subcutaneous tissue disorders
ACTINIC KERATOSIS	1/302 (0.3%)	1	0/312 (0%)	0
ALOPECIA	1/302 (0.3%)	1	0/312 (0%)	0
ANGIOEDEMA	1/302 (0.3%)	1	0/312 (0%)	0
CUTIS LAXA	1/302 (0.3%)	1	0/312 (0%)	0
DECUBITUS ULCER	3/302 (1%)	3	2/312 (0.6%)	2
DERMATITIS	0/302 (0%)	0	1/312 (0.3%)	1
DIABETIC FOOT	0/302 (0%)	0	1/312 (0.3%)	1
DRUG ERUPTION	0/302 (0%)	0	1/312 (0.3%)	1
ECCHYMOSIS	1/302 (0.3%)	1	2/312 (0.6%)	2
ECZEMA	1/302 (0.3%)	1	0/312 (0%)	0
HYPERHIDROSIS	1/302 (0.3%)	1	0/312 (0%)	0
INCREASED TENDENCY TO BRUISE	1/302 (0.3%)	1	0/312 (0%)	0
INGROWING NAIL	1/302 (0.3%)	1	0/312 (0%)	0
PETECHIAE	0/302 (0%)	0	1/312 (0.3%)	1
PRURITUS ALLERGIC	0/302 (0%)	0	1/312 (0.3%)	1
RASH	1/302 (0.3%)	1	1/312 (0.3%)	1
RASH ERYTHEMATOUS	1/302 (0.3%)	1	0/312 (0%)	0
SKIN HAEMORRHAGE	0/302 (0%)	0	1/312 (0.3%)	1
SKIN LESION	0/302 (0%)	0	2/312 (0.6%)	2
SKIN ULCER	1/302 (0.3%)	1	2/312 (0.6%)	2
STASIS DERMATITIS	0/302 (0%)	0	1/312 (0.3%)	1
URTICARIA	0/302 (0%)	0	1/312 (0.3%)	1
Surgical and medical procedures
CARDIAC PACEMAKER BATTERY REPLACEMENT	0/302 (0%)	0	1/312 (0.3%)	1
CHOLECYSTECTOMY	0/302 (0%)	0	1/312 (0.3%)	1
MEDICAL DEVICE BATTERY REPLACEMENT	0/302 (0%)	0	1/312 (0.3%)	1
RENAL STONE REMOVAL	1/302 (0.3%)	1	0/312 (0%)	0
ROUTINE HEALTH MAINTENANCE	1/302 (0.3%)	1	0/312 (0%)	0
Vascular disorders
AORTIC ANEURYSM	1/302 (0.3%)	1	0/312 (0%)	0
AORTIC STENOSIS	1/302 (0.3%)	1	2/312 (0.6%)	2
ARTERIOVENOUS FISTULA	1/302 (0.3%)	1	0/312 (0%)	0
DEEP VEIN THROMBOSIS	1/302 (0.3%)	1	2/312 (0.6%)	2
FEMORAL ARTERY OCCLUSION	0/302 (0%)	0	1/312 (0.3%)	1
HAEMATOMA	1/302 (0.3%)	1	0/312 (0%)	0
HAEMORRHAGE	1/302 (0.3%)	1	1/312 (0.3%)	1
HYPERTENSION	3/302 (1%)	4	6/312 (1.9%)	7
HYPOTENSION	31/302 (10.3%)	34	25/312 (8%)	27
INTERMITTENT CLAUDICATION	1/302 (0.3%)	1	0/312 (0%)	0
ORTHOSTATIC HYPERTENSION	1/302 (0.3%)	1	0/312 (0%)	0
PERIPHERAL ISCHAEMIA	1/302 (0.3%)	1	0/312 (0%)	0
SUBCLAVIAN ARTERY OCCLUSION	0/302 (0%)	0	1/312 (0.3%)	1
THROMBOPHLEBITIS SUPERFICIAL	1/302 (0.3%)	1	0/312 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.