EVEREST II Pivotal Study High Risk Registry (HRR)

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01940120
• Collaborator: (none)
• Enrollment: 78
• Locations: 2
• Arm: 1
• Duration (Months): 72
• Patients Per Site: 39
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

Prospective, multi-center, single arm registry. Clinical follow-up at discharge, 30 days, 6, 12, 18 and 24, months, and 3, 4 and 5 years.

Concurrent Control (CC) group identified retrospectively from the patients screened for the HRR who did not enroll; patient survival determined at 12 months. NCT00209274 (EVEREST II RCT) Intended use Percutaneous reduction of clinically significant mitral regurgitation in symptomatic patients who are considered to be high risk for operative mortality (high surgical risk).

Condition or Disease	Intervention/Treatment	Phase
Mitral Valve Insufficiency; Mitral Valve Regurgitation; Mitral Valve Incompetence; Mitral Regurgitation; Mitral Insufficiency	Device: Percutaneous mitral valve repair using MitraClip implant	N/A

Detailed Description

The EVEREST II HRR is a single-arm prospective, multicenter clinical trial enrolling high surgical risk patients of the EVEREST II study (NCT00209274).

Patients were considered high surgical risk if either their Society of Thoracic Surgery (STS) predicted operative mortality risk was ≥ 12%, or the surgeon investigator determined the patient to be high risk (≥ 12% predicted operative mortality risk) due to the presence of, at a minimum, one of the following pre-specified risk factors:

• Porcelain aorta or mobile ascending aortic atheroma

• Post-radiation mediastinum

• Previous mediastinitis

• Functional MR with ejection fraction (EF) < 40%

• Over 75 years old with EF < 40%

• Prior re-operation with patent grafts

• Two or more prior chest surgeries

• Hepatic cirrhosis

• Three or more of the following STS high risk factors:

1. Creatinine > 2.5 mg/dL ii. Prior chest surgery iii. Age over 75 iv. EF < 35%

Upon completion of enrollment in the HRR, a process was initiated to ensure patient consent to participate in a Concurrent Control (CC) group was in place. Patients were identified to determine survival through 12 months with current standard of care treatment.CC patients were derived from a cohort of patients screened for enrollment in the HRR,yet did not enroll. All patients had moderate-to-severe (3+) or severe (4+) MR based on transthoracic echocardiography (TTE). To be considered eligible for inclusion in the CC group, the patient had to be classified as high surgical risk using the same criteria used for the HRR. Upon follow-up with the clinical sites, it was determined that some of the initially identified patients with moderate-to-severe (3+) or severe (4+) MR met the criteria for high surgical risk. Of these patients, some were not included due to; lack of Institutional Review Board (IRB) approval at the site, lack of informed consent and unable to be contacted. The remaining patients make up the CC group.

Study Design

• Study Type: Interventional
• Actual Enrollment: 78 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study of the Evalve® Cardiovascular Valve Repair (MitraClip®) System Endovascular Valve Edge-to-Edge REpair STudy (EVEREST II) EVEREST II High Risk Registry
• Study Start Date: Feb 1, 2007
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High Risk Registry Arm Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.	Device: Percutaneous mitral valve repair using MitraClip implant; Procedure/Surgery: Mitral valve repair or replacement surgery Repair or replacement of mitral valve; Other Names: MitraClip MitraClip Implant

Outcome Measures

Primary Outcome Measures

1. Composite Functional and Structural Measures - Freedom From Death [12 months]

   Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint. Death is further divided into 2 categories: A. Cardiac death is defined as death due to any of the following: Acute myocardial infarction. Cardiac perforation/pericardial tamponade. Arrhythmia or conduction abnormality. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure. Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery. Any death for which a cardiac cause cannot be excluded. B. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

2. Percentage of Participants With Freedom From Death and Mitral Regurgitation (MR) >2+ [12 months]

   Kaplan-Meier estimated percentage of patients who are alive and have a mitral regurgitation severity grade of 2+ or less

3. Number of Participants With Clinical Measures of Benefit-New York Heart Association (NYHA) Class [30 days]

   The major effectiveness endpoint is an assessment of multiple functional and structural measures of benefit including New York Heart Association (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. They 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.

4. Number of Participants With New York Heart Association (NYHA) Class [12 months]

   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. They 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.

5. Clinical Measures of Benefit-Quality of Life (QOL) as Measured by Short Form (SF) 36 [12 months]

   Standardized quality of life surveys allow physicians to evaluate the effectiveness of different treatment methods and the physical and psychological benefits a patient is likely to receive from a particular treatment.In the EVEREST II HRR,the patients were asked to complete the SF-36 QOL survey at baseline, 30 days and 12 months. The physical & mental function were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. The PCS & MCS norms for 65-75 year olds are 44 and 52 respectively; and 31 & 46 for congestive heart failure (CHF) patients respectively. Each scale from the SF-36 is an algebraic sum of responses for all items in that scale.For ease of analysis each scale is then transformed to a 0-100 scale using a formula that converts the lowest & highest possible scores to 0 & 100 respectively.The scoring of the SF-36 indicates that 0% in a domain represents the poorest possible QoL & 100% indicates full QoL.

6. Left Ventricular End Diastolic Volume (LVEDV) [12 months]

   Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

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

   Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

8. Left Ventricular (LV) Function - Internal Dimension [12 months]

   Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

9. Number of Patients With CHF Having Hospitalization During Discharge Through 12 Months [12 months]

   Number of patients with incidence of re-hospitalizations for CHF in the 12-months after the MitraClip implant procedure.

10. Number of CHF Events Leading to Hospitalizations During Discharge Through 12 Months [12 months]

    Incidence of re-hospitalizations for CHF in the 12-months after the MitraClip implant procedure.

11. Left Ventricular End Diastolic Volume (LVEDV) [Discharge or 30 days]

    Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

12. Left Ventricular End Systolic Volume (LVESV) [Discharge or 30 days]

    Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

13. Left Ventricular (LV) Function - Internal Dimension [Discharge or 30 days]

    Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

Secondary Outcome Measures

1. Number of Participants Experiencing Major Adverse Events (MAE) [30 days]

   Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.

2. Number of Participants Experiencing Major Adverse Events [12 months]

   Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.

3. Procedural Freedom From In-hospital MAE [30 Days]

   Percutaneous Clip procedure or surgery with no occurrence of in-hospital MAE.

4. Number of Participants Over 75 Years of Age With MAE [30 days]

   Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.

5. Number of Participants Over 75 Years of Age With MAE [12 months]

   Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.

6. Number of Participants Experiencing Major Vascular Complications [30 days]

   Defined as the occurrence of any of the following resulting from the index procedure: Hematoma at access site >6 cm; Retroperitoneal hematoma; Arterial-venous fistula; Symptomatic peripheral ischemia/ nerve injury with clinical signs or symptoms lasting >24 hours; Vascular surgical repair at catheter access sites; Pulmonary embolism; Ipsilateral deep vein thrombus; or Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.

7. Number of Participants Experiencing Major Vascular Complications [12 months]

   Defined as the occurrence of any of the following resulting from the index procedure: Hematoma at access site >6 cm; Retroperitoneal hematoma; Arterial-venous fistula; Symptomatic peripheral ischemia/ nerve injury with clinical signs or symptoms lasting >24 hours; Vascular surgical repair at catheter access sites; Pulmonary embolism; Ipsilateral deep vein thrombus; or Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.

8. Number of Participants With Major Bleeding Complications [30 days]

   Defined as procedure related bleeding that requires a transfusion of ≥2 units of blood and/or surgical intervention.

9. Number of Participants With Major Bleeding Complications [12 months]

   Defined as procedure related bleeding that requires a transfusion of ≥2 units of blood and/or surgical intervention.

10. Number of Participants With Non-cerebral Thromboembolism [30 days]

    Defined as any mural thrombus or thromboembolism in the vasculature (excluding central nervous system events) confirmed by standard clinical and laboratory testing and which requires intervention.

11. Number of Participants With Non-cerebral Thromboembolism [12 months]

    Defined as any mural thrombus or thromboembolism in the vasculature (excluding central nervous system events) confirmed by standard clinical and laboratory testing and which requires intervention.

12. Number of Participants With Thrombosis [30 days]

    Evidence of formation of an independently moving thrombus on any part of the Clip or any commercially available implant used during surgery by echocardiography or fluoroscopy. If Clip is explanted or an autopsy is performed this diagnosis should be confirmed.

13. Number of Participants With Thrombosis [12 months]

    Evidence of formation of an independently moving thrombus on any part of the Clip or any commercially available implant used during surgery by echocardiography or fluoroscopy. If Clip is explanted or an autopsy is performed this diagnosis should be confirmed.

14. Number of Participants With Hemolysis [30 days]

    Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on two measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms

15. Number of Participants With Hemolysis [12 months]

    Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on two measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms.

16. Number of Participants With Dysrhythmias [30 days]

    Includes all new onset atrial fibrillation and heart block requiring placement of a permanent pacemaker.

17. Number of Participants With Dysrhythmias [12 months]

    Includes all new onset atrial fibrillation and heart block requiring placement of a permanent pacemaker.

18. Number of Participants With Endocarditis [30 days]

    Using Duke Criteria, endocarditis can be confirmed by: Pathological criteria: Endocarditis is confirmed if microorganisms are identified by culture or histology in a vegetation, embolized vegetation, or an intracardiac abscess; or if pathological lesions are observed & histologically confirmed showing active endocarditis. Clinical criteria: Endocarditis is confirmed by the presence of 2 major criteria, 1 major plus 3 minor criteria, or 5 minor criteria. Major criteria include persistently +ve blood cultures with the presence of typical organisms for endocarditis; persistent bacteremia; evidence of endocardial involvement with positive echocardiogram with signs of oscillating vegetation, abscesses, valve perforation, new partial dehiscence of prosthetic valve or new valvular regurgitation. Minor criteria include predisposing heart condition, fever, vascular phenomena, immunologic phenomena, & positive blood culture or echocardiogram not meeting major criteria.

19. Number of Participants With Endocarditis [12 months]

    Using Duke Criteria, endocarditis can be confirmed by: Pathological criteria: Endocarditis is confirmed if microorganisms are identified by culture or histology in a vegetation, embolized vegetation, or an intracardiac abscess; or if pathological lesions are observed & histologically confirmed showing active endocarditis. Clinical criteria: Endocarditis is confirmed by the presence of 2 major criteria, 1 major plus 3 minor criteria, or 5 minor criteria. Major criteria include persistently +ve blood cultures with the presence of typical organisms for endocarditis; persistent bacteremia; evidence of endocardial involvement with positive echocardiogram with signs of oscillating vegetation, abscesses, valve perforation, new partial dehiscence of prosthetic valve or new valvular regurgitation. Minor criteria include predisposing heart condition, fever, vascular phenomena, immunologic phenomena, & positive blood culture or echocardiogram not meeting major criteria.

20. Number of Participants With Atrial Septal Defect (ASD) [30 days]

    Occurrence of clinically significant ASD as a result of the procedure requiring intervention.

21. Number of Participants With Atrial Septal Defect (ASD) [12 months]

    Occurrence of clinically significant ASD as a result of the procedure requiring intervention.

22. Number of Participants With Mitral Valve Stenosis [30 days]

    Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.

23. Number of Participants With Mitral Valve Stenosis [12 months]

    Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.

24. Number of Participants With Mitral Valve Stenosis [24 months]

    Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.

25. Number of Participants With Mitral Valve Stenosis [36 months]

    Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.

26. Number of Participants With Mitral Valve Stenosis [48 months]

    Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.

27. Mitral Valve Area: By Planimetry [30 days]

    Mitral valve area as measured by core lab echocardiography.

28. Mitral Valve Area: By Planimetry [12 months]

    Mitral valve area as measured by core lab echocardiography.

29. Mitral Valve Area: By Planimetry [24 months]

    Mitral valve area as measured by core lab echocardiography.

30. Mitral Valve Area: By Planimetry [36 months]

    Mitral valve area as measured by core lab echocardiography.

31. Mitral Valve Area: By Planimetry [48 months]

    Mitral valve area as measured by core lab echocardiography.

32. Mitral Valve Area: By Planimetry [60 months]

    Mitral valve area as measured by core lab echocardiography.

33. Mitral Valve Area: By Pressure Half-time [30 days]

    Mitral valve area as measured by core lab echocardiography.

34. Mitral Valve Area: By Pressure Half-time [12 months]

    Mitral valve area as measured by core lab echocardiography.

35. Mitral Valve Area: By Pressure Half-time [24 months]

    Mitral valve area as measured by core lab echocardiography.

36. Mitral Valve Area: By Pressure Half-time [36 months]

    Mitral valve area as measured by core lab echocardiography.

37. Mitral Valve Area: By Pressure Half-time [48 months]

    Mitral valve area as measured by core lab echocardiography.

38. Mitral Valve Area: By Pressure Half-time [60 months]

    Mitral valve area as measured by core lab echocardiography.

39. Mitral Valve Area Index : By Planimetry [30 days]

    Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].

40. Mitral Valve Area Index : By Planimetry [12 months]

    Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].

41. Mitral Valve Area Index : By Planimetry [24 months]

    Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].

42. Mitral Valve Area Index : By Planimetry [36 months]

    Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].

43. Mitral Valve Area Index : By Planimetry [48 months]

    Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].

44. Mitral Valve Area Index : By Planimetry [60 months]

    Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].

45. Mitral Valve Area (MVA) Index: by Pressure-Half Time Formula [30 days]

    Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to Body surface area (BSA). [MVA Index = MVA (cm^2)/BSA (m^2)]

46. Mitral Valve Area Index : By Pressure Half-time Formula [12 months]

    Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].

47. Mitral Valve Area Index : By Pressure Half-time Formula [24 months]

    Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].

48. Mitral Valve Area Index : By Pressure Half-time Formula [36 months]

    Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].

49. Mitral Valve Area Index : By Pressure Half-time Formula [48 months]

    Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].

50. Mitral Valve Area Index : By Pressure Half-time Formula [60 months]

    Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].

51. Transvalvular Mitral Valve Gradient [30 days]

    Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.

52. Transvalvular Mitral Valve Gradient [12 months]

    Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.

53. Transvalvular Mitral Valve Gradient [24 months]

    Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.

54. Transvalvular Mitral Valve Gradient [36 months]

    Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.

55. Transvalvular Mitral Valve Gradient [48 months]

    Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.

56. Transvalvular Mitral Valve Gradient [60 months]

    Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.

57. Mitral Valve Index [30 days]

    Mitral valve area as measured by core lab echocardiography and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)]

58. Mitral Valve Index [12 months]

    Mitral valve area as measured by core lab echocardiography and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)]

59. Number of Participants With New Coumadin Use [30 days]

    New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.

60. Number of Participants With New Coumadin Use [6 months]

    New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.

61. Number of Participants With New Coumadin Use [12 months]

    New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.

62. Number of Participants Discharged to a Nursing Home or Skilled Nursing Facility or Hospital [30 Days]

    Discharge to a nursing home or skilled nursing facility following discharge from the hospital after definitive treatment.

63. Post-procedure Length of Hospital Stay [Length of Hospital Stay, assessed at 30 days]

    Defined as the number of days from the end of the procedure until the patient is discharged from the hospital. This does not include time in a nursing or skilled care facility.

64. Post-procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU) Time [Length of ICU/CCU stay, assessed at 30 Days]

    Number of hours patients are in an intensive care unit or step down unit before discharge or moving to a standard care unit.

65. Number of Participants With Successful Clip Implant [30 Days]

    Rate of successful delivery and deployment of Clip implants with echocardiographic evidence of leaflet approximation and retrieval of the investigational delivery catheter.

66. Number of Participants With High Risk Procedural Success [30 days]

    Successful implantation of the Clip (s) with resulting MR severity of 2+ of less at discharge or a 1 grade MR reduction at discharge accompanied by a 1 level reduction in NYHA.

67. Number of Participants With MR Severity [Discharge or 30 days]

    MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.

68. Number of Participants With MR Severity [12 months]

    MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.

69. Number of Participants With MR Severity [24 months]

    MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.

70. Number of Participants With MR Severity [36 months]

    MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.

71. Number of Participants With MR Severity [48 months]

    MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.

72. Number of Participants With MR Severity [60 months]

    MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.

73. Number of Participants With Treatment Durability [12 months]

    Defined as the proportion of Acute Procedural Success patients with MR severity grade of 2+ or less that have not required surgery for valve dysfunction.

74. Number of Participants With Treatment Durability [24 months]

    Defined as the proportion of Acute Procedural Success patients with MR severity grade of 2+ or less that have not required surgery for valve dysfunction.

75. Number of Participants With Clinical Durability [12 months]

    Proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA.

76. Number of Participants With Clinical Durability [24 months]

    Proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA.

77. Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class [24 months]

    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. They 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.

78. Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class [36 months]

    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. They 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.

79. Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class [48 months]

    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. They 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.

80. Number of Participants With New York Heart Association (NYHA) Class [60 months]

    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. They 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.

81. Left Ventricular End-diastolic Volume (LVEDV). [24 months]

    Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

82. Left Ventricular End-diastolic Volume (LVEDV). [36 months]

    Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

83. Left Ventricular End-diastolic Volume (LVEDV). [48 months]

    Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

84. Left Ventricular End-diastolic Volume (LVEDV). [60 months]

    Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

85. Left Ventricular End-systolic Volume (LVESV). [24 months]

    Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

86. Left Ventricular End-systolic Volume (LVESV). [36 months]

    Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

87. Left Ventricular End-systolic Volume (LVESV). [48 months]

    Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

88. Left Ventricular End-systolic Volume (LVESV). [60 months]

    Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

89. Left Ventricular Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs) [24 months]

    Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

90. Left Ventricular Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs) [36 months]

    Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

91. Left Ventricular Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs) [48 months]

    Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

92. Left Ventricular Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs) [60 months]

    Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).

93. Number of Days Re-hospitalized for CHF [12 months]

    Defined as the number of days hospitalized for CHF in the 12-months prior to the Clip implant procedure date compared to the number of days re-hospitalized for CHF in the 12-months after Clip implant.

94. Number of Hospital Re-Admissions for Congestive Heart Failure (CHF) [12 months]

    Defined as the number of hospital admissions (i.e. events) for which the primary diagnosis for hospitalization is congestive heart failure, in the 12-months post-discharge following the MitraClip procedure.

95. Regurgitant Volume [30 days]

    Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.

96. Regurgitant Volume [12 months]

    Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.

97. Regurgitant Volume [24 months]

    Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.

98. Regurgitant Fraction (RF) [30 days]

    RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.

99. Regurgitant Fraction [12 months]

    RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.

100. Regurgitant Fraction [24 months]

     RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.

101. Cardiac Output (CO) [30 Days]

     CO is defined as the volume of blood pumped by the left ventricle per unit time (L/min).

102. Cardiac Output [12 months]

     CO is defined as the volume of blood pumped by the left ventricle per unit time (L/min)

103. Cardiac Output [24 months]

     CO is defined as the volume of blood pumped by the left ventricle per unit time (L/min)

104. Cardiac Index [30 Days]

     Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.

105. Cardiac Index [12 months]

     Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.

106. Cardiac Index [24 months]

     Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.

107. Left Ventricular Ejection Fraction (LVEF) [Discharge or 30 days]

     Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.

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

     Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.

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

     Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.

110. Left Ventricular Ejection Fraction (LVEF) [36 months]

     Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.

111. Left Ventricular Ejection Fraction (LVEF) [48 months]

     Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.

112. Left Ventricular Ejection Fraction (LVEF) [60 months]

     Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.

113. Percentage of Participants With Freedom From Mitral Valve Surgery [Baseline]

     Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure

114. Percentage of Participants With Freedom From Mitral Valve Surgery [12 months]

     Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure

115. Percentage of Participants With Freedom From Mitral Valve Surgery [24 months]

     Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure

116. Percentage of Participants With Freedom From Mitral Valve Surgery [36 months]

     Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure

117. Percentage of Participants With Freedom From Mitral Valve Surgery [48 months]

     Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure

118. Percentage of Participants With Freedom From Mitral Valve Surgery [60 months]

     Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure

119. Number of Participants With Mitral Valve Repair Success [12 months]

     Mitral Valve Repair Success defined as freedom from mitral valve replacement surgery for valve dysfunction, death, re-operation and MR > 2+ at 12 months.

120. Number of Participants With Mitral Valve Repair Success [24 months]

     Freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+.

121. Composite Functional and Structural Measures - Percentage of Participants With Freedom From Death [24 months]

     Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint. Death is further divided into 2 categories: A. Cardiac death is defined as death due to any of the following: Acute myocardial infarction. Cardiac perforation/pericardial tamponade. Arrhythmia or conduction abnormality. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure. Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery. Any death for which a cardiac cause cannot be excluded. B. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

122. Percentage of Participants With Composite Functional and Structural Measures - Freedom From Death and MR >2+ [24 months]

     Kaplan-Meier estimated proportion of patients who are alive and have a mitral regurgitation severity grade of 2+ or less.

123. Number of Participants With Device Embolization or Single Leaflet Device Attachment [0 to 12 months]

     Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets. A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.

124. Number of Participants With Device Embolization or Single Leaflet Device Attachment [24 months]

     Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets. A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.

125. Number of Participants With Device Embolization or Single Leaflet Device Attachment [48 months]

     Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets. A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.

126. Number of Participants With Device Embolization or Single Leaflet Device Attachment [36 months]

     Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets. A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.

127. Number of Participants With Device Embolization or Single Leaflet Device Attachment [60 months]

     Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets. A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.

128. Number of Participants With Mitral Valve Surgery Post-MitraClip Procedure [60 months]

     Number of patients who underwent surgical mitral valve repair or replacement after the index MitraClip procedure.

129. Number of Participants With Second MitraClip Device Implanted [0 to 5 years]

     It is a summary of re-interventions to place an additional MitraClip Device.

130. Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery [12 months]

     Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure

131. Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery [24 months]

     Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure

132. Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery [36 months]

     Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure

133. Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery [48 months]

     Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure

134. Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery [60 months]

     Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure

135. Number of Participants With Mitral Valve Replacement [12 months]

     Defined as how often patients receiving surgery required replacement of the mitral valve.

136. Number of Participants With Mitral Valve Replacement [24 months]

     Defined as how often patients receiving surgery required replacement of the mitral valve.

137. Number of Participants With Mitral Valve Replacement [36 months]

     Defined as how often patients receiving surgery required replacement of the mitral valve.

138. Number of Participants With Mitral Valve Replacement [48 months]

     Defined as how often patients receiving surgery required replacement of the mitral valve.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

Candidates for the high risk arm of the study must meet all of the following inclusion criteria:

• Predicted procedural mortality risk calculated using the STS surgical risk calculator of ≥ 12% or in the judgment of the surgeon investigator the patient is considered a high risk surgical candidate due to the presence of one of the following indications:

1. Porcelain aorta or mobile ascending aortic atheroma

2. Post-radiation mediastinum

3. Previous mediastinitis

4. Functional MR with EF<40

5. Over 75 years old with EF<40

6. Re-operation with patent grafts

7. Two or more prior chest surgeries

8. Hepatic cirrhosis i Three or more of the following STS high risk factors: i) Creatinine > 2.5 mg/dL ii) Prior chest surgery iii) Age over 75 iv) EF<35

• Age 18 years or older.

• Symptomatic moderate to severe (3+) or severe (4+) chronic mitral regurgitation (MR) and in the judgment of the investigator intervention to reduce MR is likely to provide symptomatic relief for the patient. MR is determined as defined in Appendix A of the EVEREST II study protocol. American Society of Anesthesiologists (ASA) physical status classification of ASA IV or lower.

• The primary regurgitant jet originates from malcoaptation of the A2 and P2 scallops of the mitral valve.

• Male or Female. Female subjects of childbearing potential must have a negative pregnancy test within seven (7) days before the procedure.

• The subject or the subject's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board of the respective clinical site.

• The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

• Transseptal catheterization is determined to be feasible by the treating physician.

Exclusion Criteria:

Candidates will be excluded from the study if any of the following conditions are present:

• Evidence of an acute myocardial infarction in the prior 2 weeks of the intended treatment (defined as: Q wave or non-Q wave infarction having creatine kinase (CK) enzymes ≥ two times (2X) the upper laboratory normal limit with the presence of a Creatine Kinase MB Isoenzyme (CKMB) elevated above the institution's upper limit of normal).

• In the judgment of the Investigator, the femoral vein cannot accommodate a 24 F catheter or presence of ipsilateral deep vein thrombosis (DVT).

• Ejection fraction < 20%, and/or end-systolic dimension > 60 mm as defined in Appendix A of the EVEREST II protocol.

• Mitral valve orifice area < 4.0 cm2 as defined in Appendix A of the EVEREST II protocol.

• If leaflet flail is present:

1. Flail Width: the width of the flail segment is greater than or equal to 15 mm, as defined in Section 4.3 and Appendix A, or

2. Flail Gap: the flail gap is greater than or equal to 10 mm, as defined in Section 4.3 and Appendix A.

• If leaflet tethering is present:

a). Coaptation Length: the vertical coaptation length is less than 2 mm, as defined in Section 4.3 and Appendix A.

• Leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in MR. This may include:

• Evidence of calcification in the grasping area of the A2 and/or P2 scallops

• Presence of a significant cleft of A2 or P2 scallops

• More than one anatomic criteria dimensionally near the exclusion limits

• Bileaflet flail or severe bileaflet prolapse

• Lack of both primary and secondary chordal support

• Hemodynamic instability defined as systolic pressure < 90 mmHg without after load reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump.

• Need for emergent or urgent surgery for any reason.

• Prior mitral valve leaflet surgery or any currently implanted mechanical prosthetic mitral valve.

• Echocardiographic evidence of intracardiac mass, thrombus or vegetation.

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

• History of bleeding diathesis or coagulopathy or subject will refuse blood transfusions.

• Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll 2 weeks after discontinuation of antibiotics). Patients must be free from infection prior to treatment. Any required dental work should be completed a minimum of 3 weeks prior to treatment.

• Intravenous drug abuse or suspected inability to adhere to follow-up.

• Patients in whom transesophageal echocardiography (TEE) is contraindicated.

• A known hypersensitivity or contraindication to study or

• In the judgment of the Investigator, patients in whom the presence of a permanent pacemaker or pacing leads would interfere with placement of the test device or the placement of the test device would disrupt the leads.

• Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. [Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials].

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Evanston Northwestern Healthcare 2650 Ridge Ave., Walgreen Bldg, 3rd Floor, Cardiology	Evanston	Illinois	United States	60201
2	The Care Group Heart Center 10590 N. Meridian, Ste. 300	Indianapolis	Indiana	United States	46290

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Ted Feldman, M.D., NorthShore University HealthSystem
• Principal Investigator: Donald G Glower Jr.,, M.D., Duke University Medical Center, Department of Surgery

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Sponsor information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT01940120
• Other Study ID Numbers: 0401A
• First Posted: Sep 12, 2013
• Last Update Posted: Nov 7, 2018
• Last Verified: Nov 1, 2018

• Keywords provided by Abbott Medical Devices: Mitral Valve Insufficiency; Mitral Valve Regurgitation; Mitral Valve Incompetence; Mitral Regurgitation; Mitral Insufficiency; Mitral Valve; MR; Mitral Valve Prolapse; Edge to Edge (E2E); Alfieri Technique; MitraClip; Functional MR; Degenerative MR; Echocardiogram; Coronary Artery Disease (CAD); Heart Failure; Heart Attack; EVEREST; EVEREST I; EVEREST II; REALISM
• Additional relevant MeSH terms: Mitral Valve Insufficiency

Study Results

Participant Flow

Recruitment Details	Patients who met eligibility criteria for the study and had a MitraClip procedure, whether a Device was implanted or not, were considered enrolled in the Registry. A total of 78 patients were enrolled at 35 North American sites. Screening period: Jan, 2007-2008. Enrollment period: Feb 14, 2007- Jan 30, 2008.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Period Title: Overall Study
STARTED	78
COMPLETED	30
NOT COMPLETED	48

Baseline Characteristics

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Participants	78
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	76.7 (9.8)
Age, Customized (participants) [Number]
18-75 years	30 38.5%
>75 years	48 61.5%
Sex: Female, Male (Count of Participants)
Female	29 37.2%
Male	49 62.8%
Region of Enrollment (participants) [Number]
United States	77 98.7%
Canada	1 1.3%
Predicted Surgical Mortality (Probability percentage) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Probability percentage]	18.2 (8.0)
LV Measurement (mL) [Mean (Standard Deviation) ]
Left Ventricular End Diastolic Volume (LVEDV)	166.5 (50.7)
Left Ventricular End Systolic Volume (LVESV)	79.9 (42.7)
LV Measurement (cm) [Mean (Standard Deviation) ]
Left Ventricular Internal Diameter Diastole(LVIDd)	5.6 (0.7)
Left Ventricular Internal Diameter Systole (LVIDs)	3.9 (1.1)
36-Item Short Form Health Survey (SF-36) Quality of Life (scores on a scale) [Mean (Standard Deviation) ]
Physical Health (PCS)	31.6 (9.1)
Mental Health (MCS)	44.2 (12.6)
NYHA Functional Class (participants) [Number]
NYHA Functional Class I	0 0%
NYHA Functional Class II	8 10.3%
NYHA Functional Class III	47 60.3%
NYHA Functional Class IV	23 29.5%
Number of patients hospitalized for CHF during 12 months before enrollment (participants) [Number]
Number of patients hospitalized for CHF	33 42.3%
Number of patients not hospitalized for CHF	45 57.7%
Number of CHF events leading to hospitalizations during 12 months before enrollment (events) [Number]
Number [events]	51
Number of hospitalization days for CHF at 12 months before enrollment (days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days]	6.0 (4.6)

Outcome Measures

1. Primary Outcome

Title	Composite Functional and Structural Measures - Freedom From Death
Description	Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint. Death is further divided into 2 categories: A. Cardiac death is defined as death due to any of the following: Acute myocardial infarction. Cardiac perforation/pericardial tamponade. Arrhythmia or conduction abnormality. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure. Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery. Any death for which a cardiac cause cannot be excluded. B. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Count of Participants [Participants]	59 75.6%

2. Primary Outcome

Title	Percentage of Participants With Freedom From Death and Mitral Regurgitation (MR) >2+
Description	Kaplan-Meier estimated percentage of patients who are alive and have a mitral regurgitation severity grade of 2+ or less
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Primary Analysis	56.4 72.3%
Worst case Analysis	53.8 69%

3. Primary Outcome

Title	Number of Participants With Clinical Measures of Benefit-New York Heart Association (NYHA) Class
Description	The major effectiveness endpoint is an assessment of multiple functional and structural measures of benefit including New York Heart Association (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. They 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	30 days

Outcome Measure Data

Analysis Population Description

71 out of 78 patients (at baseline) were analyzed at 30 days. There were 6 deaths prior to 30 days. So, NYHA at 30 days is missing due to death in 6 patients, and missing due to other reasons in 1 patient.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	71
NYHA Functional Class I	14 17.9%
NYHA Functional Class II	38 48.7%
NYHA Functional Class III	16 20.5%
NYHA Functional Class IV	3 3.8%

4. Primary Outcome

Title	Number of Participants With New York Heart Association (NYHA) Class
Description	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. They 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

Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and 2 patients without NYHA Class assessment.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	54
NYHA Functional Class I	18 23.1%
NYHA Functional Class II	22 28.2%
NYHA Functional Class III	13 16.7%
NYHA Functional Class IV	1 1.3%

5. Primary Outcome

Title	Clinical Measures of Benefit-Quality of Life (QOL) as Measured by Short Form (SF) 36
Description	Standardized quality of life surveys allow physicians to evaluate the effectiveness of different treatment methods and the physical and psychological benefits a patient is likely to receive from a particular treatment.In the EVEREST II HRR,the patients were asked to complete the SF-36 QOL survey at baseline, 30 days and 12 months. The physical & mental function were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. The PCS & MCS norms for 65-75 year olds are 44 and 52 respectively; and 31 & 46 for congestive heart failure (CHF) patients respectively. Each scale from the SF-36 is an algebraic sum of responses for all items in that scale.For ease of analysis each scale is then transformed to a 0-100 scale using a formula that converts the lowest & highest possible scores to 0 & 100 respectively.The scoring of the SF-36 indicates that 0% in a domain represents the poorest possible QoL & 100% indicates full QoL.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	47
PCS	36.1 (10.8)
MCS	48.7 (11.9)

6. Primary Outcome

Title	Left Ventricular End Diastolic Volume (LVEDV)
Description	Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and LVEDV was not done or un-evaluable in 2 patients.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	54
Mean (Standard Deviation) [ml]	139.7 (42.6)

7. Primary Outcome

Title	Left Ventricular End Systolic Volume (LVESV)
Description	Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and LVESV was not done or un-evaluable in 2 patients.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	54
Mean (Standard Deviation) [ml]	72.2 (35.8)

8. Primary Outcome

Title	Left Ventricular (LV) Function - Internal Dimension
Description	Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and LIVDs/LVIDs evaluation was not done or un-evaluable in 2 patients.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	54
LV Internal Dimension diastole (LVIDd)	5.3 (0.7)
LV Internal Dimension systole (LVIDs)	3.8 (1.0)

9. Primary Outcome

Title	Number of Patients With CHF Having Hospitalization During Discharge Through 12 Months
Description	Number of patients with incidence of re-hospitalizations for CHF in the 12-months after the MitraClip implant procedure.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Three patients died before discharge and thus do not provide data on post-discharge hospitalizations.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	75
Count of Participants [Participants]	12 15.4%

10. Primary Outcome

Title	Number of CHF Events Leading to Hospitalizations During Discharge Through 12 Months
Description	Incidence of re-hospitalizations for CHF in the 12-months after the MitraClip implant procedure.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Three patients died before discharge and thus do not provide data on post-discharge hospitalizations.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	75
Count of Participants [Participants]	22 28.2%

11. Primary Outcome

Title	Left Ventricular End Diastolic Volume (LVEDV)
Description	Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame	Discharge or 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	75
Mean (Standard Deviation) [ml]	147.9 (48.8)

12. Primary Outcome

Title	Left Ventricular End Systolic Volume (LVESV)
Description	Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame	Discharge or 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	75
Mean (Standard Deviation) [ml]	74.3 (40.4)

13. Primary Outcome

Title	Left Ventricular (LV) Function - Internal Dimension
Description	Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame	Discharge or 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	76
LV Internal Dimension diastole (LVIDd)	5.4 (0.8)
LV Internal Dimension systole (LVIDs)	3.9 (1.0)

14. Secondary Outcome

Title	Number of Participants Experiencing Major Adverse Events (MAE)
Description	Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Count of Participants [Participants]	21 26.9%

15. Secondary Outcome

Title	Number of Participants Experiencing Major Adverse Events
Description	Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Count of Participants [Participants]	33 42.3%

16. Secondary Outcome

Title	Procedural Freedom From In-hospital MAE
Description	Percutaneous Clip procedure or surgery with no occurrence of in-hospital MAE.
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Number [participants]	61 78.2%

17. Secondary Outcome

Title	Number of Participants Over 75 Years of Age With MAE
Description	Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Analysis population includes 48 patients who were aged 75 years or older in the study.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	48
Count of Participants [Participants]	14 17.9%

18. Secondary Outcome

Title	Number of Participants Over 75 Years of Age With MAE
Description	Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Analysis population includes 48 patients who were aged 75 years or older in the study.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	48
Count of Participants [Participants]	23 29.5%

19. Secondary Outcome

Title	Number of Participants Experiencing Major Vascular Complications
Description	Defined as the occurrence of any of the following resulting from the index procedure: Hematoma at access site >6 cm; Retroperitoneal hematoma; Arterial-venous fistula; Symptomatic peripheral ischemia/ nerve injury with clinical signs or symptoms lasting >24 hours; Vascular surgical repair at catheter access sites; Pulmonary embolism; Ipsilateral deep vein thrombus; or Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Count of Participants [Participants]	2 2.6%

20. Secondary Outcome

Title	Number of Participants Experiencing Major Vascular Complications
Description	Defined as the occurrence of any of the following resulting from the index procedure: Hematoma at access site >6 cm; Retroperitoneal hematoma; Arterial-venous fistula; Symptomatic peripheral ischemia/ nerve injury with clinical signs or symptoms lasting >24 hours; Vascular surgical repair at catheter access sites; Pulmonary embolism; Ipsilateral deep vein thrombus; or Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Count of Participants [Participants]	3 3.8%

21. Secondary Outcome

Title	Number of Participants With Major Bleeding Complications
Description	Defined as procedure related bleeding that requires a transfusion of ≥2 units of blood and/or surgical intervention.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Count of Participants [Participants]	13 16.7%

22. Secondary Outcome

Title	Number of Participants With Major Bleeding Complications
Description	Defined as procedure related bleeding that requires a transfusion of ≥2 units of blood and/or surgical intervention.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Count of Participants [Participants]	15 19.2%

23. Secondary Outcome

Title	Number of Participants With Non-cerebral Thromboembolism
Description	Defined as any mural thrombus or thromboembolism in the vasculature (excluding central nervous system events) confirmed by standard clinical and laboratory testing and which requires intervention.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Count of Participants [Participants]	0 0%

24. Secondary Outcome

Title	Number of Participants With Non-cerebral Thromboembolism
Description	Defined as any mural thrombus or thromboembolism in the vasculature (excluding central nervous system events) confirmed by standard clinical and laboratory testing and which requires intervention.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Count of Participants [Participants]	1 1.3%

25. Secondary Outcome

Title	Number of Participants With Thrombosis
Description	Evidence of formation of an independently moving thrombus on any part of the Clip or any commercially available implant used during surgery by echocardiography or fluoroscopy. If Clip is explanted or an autopsy is performed this diagnosis should be confirmed.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Count of Participants [Participants]	0 0%

26. Secondary Outcome

Title	Number of Participants With Thrombosis
Description	Evidence of formation of an independently moving thrombus on any part of the Clip or any commercially available implant used during surgery by echocardiography or fluoroscopy. If Clip is explanted or an autopsy is performed this diagnosis should be confirmed.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Count of Participants [Participants]	0 0%

27. Secondary Outcome

Title	Number of Participants With Hemolysis
Description	Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on two measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Count of Participants [Participants]	0 0%

28. Secondary Outcome

Title	Number of Participants With Hemolysis
Description	Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on two measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Count of Participants [Participants]	0 0%

29. Secondary Outcome

Title	Number of Participants With Dysrhythmias
Description	Includes all new onset atrial fibrillation and heart block requiring placement of a permanent pacemaker.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Count of Participants [Participants]	5 6.4%

30. Secondary Outcome

Title	Number of Participants With Dysrhythmias
Description	Includes all new onset atrial fibrillation and heart block requiring placement of a permanent pacemaker.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Count of Participants [Participants]	8 10.3%

31. Secondary Outcome

Title	Number of Participants With Endocarditis
Description	Using Duke Criteria, endocarditis can be confirmed by: Pathological criteria: Endocarditis is confirmed if microorganisms are identified by culture or histology in a vegetation, embolized vegetation, or an intracardiac abscess; or if pathological lesions are observed & histologically confirmed showing active endocarditis. Clinical criteria: Endocarditis is confirmed by the presence of 2 major criteria, 1 major plus 3 minor criteria, or 5 minor criteria. Major criteria include persistently +ve blood cultures with the presence of typical organisms for endocarditis; persistent bacteremia; evidence of endocardial involvement with positive echocardiogram with signs of oscillating vegetation, abscesses, valve perforation, new partial dehiscence of prosthetic valve or new valvular regurgitation. Minor criteria include predisposing heart condition, fever, vascular phenomena, immunologic phenomena, & positive blood culture or echocardiogram not meeting major criteria.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Count of Participants [Participants]	0 0%

32. Secondary Outcome

Title	Number of Participants With Endocarditis
Description	Using Duke Criteria, endocarditis can be confirmed by: Pathological criteria: Endocarditis is confirmed if microorganisms are identified by culture or histology in a vegetation, embolized vegetation, or an intracardiac abscess; or if pathological lesions are observed & histologically confirmed showing active endocarditis. Clinical criteria: Endocarditis is confirmed by the presence of 2 major criteria, 1 major plus 3 minor criteria, or 5 minor criteria. Major criteria include persistently +ve blood cultures with the presence of typical organisms for endocarditis; persistent bacteremia; evidence of endocardial involvement with positive echocardiogram with signs of oscillating vegetation, abscesses, valve perforation, new partial dehiscence of prosthetic valve or new valvular regurgitation. Minor criteria include predisposing heart condition, fever, vascular phenomena, immunologic phenomena, & positive blood culture or echocardiogram not meeting major criteria.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Count of Participants [Participants]	1 1.3%

33. Secondary Outcome

Title	Number of Participants With Atrial Septal Defect (ASD)
Description	Occurrence of clinically significant ASD as a result of the procedure requiring intervention.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant. .
Measure Participants	78
Count of Participants [Participants]	2 2.6%

34. Secondary Outcome

Title	Number of Participants With Atrial Septal Defect (ASD)
Description	Occurrence of clinically significant ASD as a result of the procedure requiring intervention.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Count of Participants [Participants]	2 2.6%

35. Secondary Outcome

Title	Number of Participants With Mitral Valve Stenosis
Description	Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Of total 78 participants, only 72 participants were analyzed as 6 deaths within 30 days.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	72
Count of Participants [Participants]	0 0%

36. Secondary Outcome

Title	Number of Participants With Mitral Valve Stenosis
Description	Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Of total 78 participants, only 72 participants were analyzed because 3 patients were not implanted with a device and 3 patients died prior to discharge.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	72
Count of Participants [Participants]	0 0%

37. Secondary Outcome

Title	Number of Participants With Mitral Valve Stenosis
Description	Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Count of Participants [Participants]	2 2.6%

38. Secondary Outcome

Title	Number of Participants With Mitral Valve Stenosis
Description	Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Count of Participants [Participants]	2 2.6%

39. Secondary Outcome

Title	Number of Participants With Mitral Valve Stenosis
Description	Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.
Time Frame	48 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Count of Participants [Participants]	2 2.6%

40. Secondary Outcome

Title	Mitral Valve Area: By Planimetry
Description	Mitral valve area as measured by core lab echocardiography.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Of 78 total population, 50 participants were included in analysis population because of 6 deaths and Mitral Valve Area by planimetry was not done in 22 patients.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	50
Mean (Standard Deviation) [cm^2]	3.3 (0.9)

41. Secondary Outcome

Title	Mitral Valve Area: By Planimetry
Description	Mitral valve area as measured by core lab echocardiography.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 45 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 11 patients Mitral valve area evaluation was not done or un-evaluable.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	45
Mean (Standard Deviation) [cm^2]	3.0 (1.0)

42. Secondary Outcome

Title	Mitral Valve Area: By Planimetry
Description	Mitral valve area as measured by core lab echocardiography.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 19 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 25 patients Mitral valve area evaluation was not done or un-evaluable.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	19
Mean (Standard Deviation) [cm^2]	3.3 (0.6)

43. Secondary Outcome

Title	Mitral Valve Area: By Planimetry
Description	Mitral valve area as measured by core lab echocardiography.
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 25 participants were included in analysis population because of 31 deaths within 3 years, 7 withdrawals, 1 missed visit and in 14 patients mitral valve area evaluation was not done or un-evaluable.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	25
Mean (Standard Deviation) [cm^2]	2.9 (0.8)

44. Secondary Outcome

Title	Mitral Valve Area: By Planimetry
Description	Mitral valve area as measured by core lab echocardiography.
Time Frame	48 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 18 participants were included in analysis population because of 33 deaths within 4 years, 8 withdrawals, 3 missed visit and in 16 patients Mitral Valve Area evaluation was not done or un-evaluable.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	18
Mean (Standard Deviation) [cm^2]	3.0 (0.7)

45. Secondary Outcome

Title	Mitral Valve Area: By Planimetry
Description	Mitral valve area as measured by core lab echocardiography.
Time Frame	60 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	19
Mean (Standard Deviation) [cm^2]	2.9 (0.8)

46. Secondary Outcome

Title	Mitral Valve Area: By Pressure Half-time
Description	Mitral valve area as measured by core lab echocardiography.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Of 78 total population, 66 participants were included in analysis population because of 6 deaths and in 6 patients Mitral valve area evaluation was not done or un-evaluable.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	66
Mean (Standard Deviation) [cm^2]	2.9 (1.2)

47. Secondary Outcome

Title	Mitral Valve Area: By Pressure Half-time
Description	Mitral valve area as measured by core lab echocardiography.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Mitral valve area evaluation was not done or un-evaluable.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	53
Mean (Standard Deviation) [cm^2]	3.0 (1.2)

48. Secondary Outcome

Title	Mitral Valve Area: By Pressure Half-time
Description	Mitral valve area as measured by core lab echocardiography.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 40 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients Mitral valve area evaluation was not done or un-evaluable.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	40
Mean (Standard Deviation) [cm^2]	2.8 (0.8)

49. Secondary Outcome

Title	Mitral Valve Area: By Pressure Half-time
Description	Mitral valve area as measured by core lab echocardiography.
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	35
Mean (Standard Deviation) [cm^2]	2.9 (0.8)

50. Secondary Outcome

Title	Mitral Valve Area: By Pressure Half-time
Description	Mitral valve area as measured by core lab echocardiography.
Time Frame	48 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	31
Mean (Standard Deviation) [cm^2]	2.8 (0.9)

51. Secondary Outcome

Title	Mitral Valve Area: By Pressure Half-time
Description	Mitral valve area as measured by core lab echocardiography.
Time Frame	60 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	24
Mean (Standard Deviation) [cm^2]	2.8 (0.7)

52. Secondary Outcome

Title	Mitral Valve Area Index : By Planimetry
Description	Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Of 78 total population, 50 participants were included in analysis population because of 6 deaths and Mitral Valve Area Index by planimetry was not done in 22 patients.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	50
Mean (Standard Deviation) [cm^2/m^2]	1.7 (0.5)

53. Secondary Outcome

Title	Mitral Valve Area Index : By Planimetry
Description	Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 45 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 11 patients Mitral Valve Area evaluation was not done or un-evaluable.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	45
Mean (Standard Deviation) [cm^2/m^2]	1.6 (0.5)

54. Secondary Outcome

Title	Mitral Valve Area Index : By Planimetry
Description	Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 19 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 25 patients Mitral Valve Area evaluation was not done or un-evaluable

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	19
Mean (Standard Deviation) [cm^2/m^2]	1.7 (0.3)

55. Secondary Outcome

Title	Mitral Valve Area Index : By Planimetry
Description	Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	25
Mean (Standard Deviation) [cm^2/m^2]	1.5 (0.4)

56. Secondary Outcome

Title	Mitral Valve Area Index : By Planimetry
Description	Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Time Frame	48 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	18
Mean (Standard Deviation) [cm^2/m^2]	1.5 (0.4)

57. Secondary Outcome

Title	Mitral Valve Area Index : By Planimetry
Description	Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Time Frame	60 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	19
Mean (Standard Deviation) [cm^2/m^2]	1.5 (0.4)

58. Secondary Outcome

Title	Mitral Valve Area (MVA) Index: by Pressure-Half Time Formula
Description	Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to Body surface area (BSA). [MVA Index = MVA (cm^2)/BSA (m^2)]
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Of 78 total population, 65 participants were included in analysis population because of 6 deaths and Mitral Valve Area Index by pressure half-time was not done in 7 patients.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	65
Mean (Standard Deviation) [cm^2/m^2]	1.6 (0.7)

59. Secondary Outcome

Title	Mitral Valve Area Index : By Pressure Half-time Formula
Description	Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Mitral Valve Area evaluation was not done or un-evaluable

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	53
Mean (Standard Deviation) [cm^2/m^2]	1.6 (0.7)

60. Secondary Outcome

Title	Mitral Valve Area Index : By Pressure Half-time Formula
Description	Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 40 participants were included in the analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients Mitral Valve Area evaluation was not done or un-evaluable

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	40
Mean (Standard Deviation) [cm^2/m^2]	1.5 (0.5)

61. Secondary Outcome

Title	Mitral Valve Area Index : By Pressure Half-time Formula
Description	Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	35
Mean (Standard Deviation) [cm^2/m^2]	1.5 (0.5)

62. Secondary Outcome

Title	Mitral Valve Area Index : By Pressure Half-time Formula
Description	Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Time Frame	48 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	30
Mean (Standard Deviation) [cm^2/m^2]	1.5 (0.5)

63. Secondary Outcome

Title	Mitral Valve Area Index : By Pressure Half-time Formula
Description	Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Time Frame	60 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	24
Mean (Standard Deviation) [cm^2/m^2]	1.5 (0.4)

64. Secondary Outcome

Title	Transvalvular Mitral Valve Gradient
Description	Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Of 78 total population, 69 participants were included in the analysis population because of 6 deaths within 30 days and in 3 participants Mitral Valve Gradient was not done or un-evaluable.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	69
Mean (Standard Deviation) [mmHg]	3.9 (2.6)

65. Secondary Outcome

Title	Transvalvular Mitral Valve Gradient
Description	Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Mitral Valve Gradient evaluation was not done or un-evaluable.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	53
Mean (Standard Deviation) [mmHg]	3.6 (2.9)

66. Secondary Outcome

Title	Transvalvular Mitral Valve Gradient
Description	Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 40 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients Mitral Valve Gradient evaluation was not done or un-evaluable.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	40
Mean (Standard Deviation) [mmHg]	3.2 (1.9)

67. Secondary Outcome

Title	Transvalvular Mitral Valve Gradient
Description	Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 36 participants were included in analysis population because of 31 deaths within 2 years, 7 withdrawals, 1 missed visit and in 3 patients Mitral Valve Gradient evaluation was not done or un-evaluable.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	36
Mean (Standard Deviation) [mmHg]	3.8 (2.7)

68. Secondary Outcome

Title	Transvalvular Mitral Valve Gradient
Description	Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.
Time Frame	48 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 31 participants were included in analysis population because of 31 deaths within 3 years, 7 withdrawals, 1 missed visit and in 8 patients Mitral Valve Gradient evaluation was not done or un-evaluable.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	31
Mean (Standard Deviation) [mmHg]	3.6 (1.8)

69. Secondary Outcome

Title	Transvalvular Mitral Valve Gradient
Description	Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.
Time Frame	60 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	24
Mean (Standard Deviation) [mmHg]	3.8 (2)

70. Secondary Outcome

Title	Mitral Valve Index
Description	Mitral valve area as measured by core lab echocardiography and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)]
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Of 78 total population, 50 participants were included in the analysis population because of 6 deaths within 30 days and in 22 participants Mitral valve index was not done or un-evaluable.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	50
Mean (Standard Deviation) [cm^2/m^2]	1.7 (0.5)

71. Secondary Outcome

Title	Mitral Valve Index
Description	Mitral valve area as measured by core lab echocardiography and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)]
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 45 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 11 patients Mitral valve index evaluation was not done or un-evaluable.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	45
Mean (Standard Deviation) [cm^2/m^2]	1.6 (0.5)

72. Secondary Outcome

Title	Number of Participants With New Coumadin Use
Description	New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

49 patients not on coumadin at baseline are included in the analysis.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	49
Count of Participants [Participants]	9 11.5%

73. Secondary Outcome

Title	Number of Participants With New Coumadin Use
Description	New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

49 patients not on coumadin at baseline are included in the analysis.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	49
Count of Participants [Participants]	11 14.1%

74. Secondary Outcome

Title	Number of Participants With New Coumadin Use
Description	New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

49 patients not on coumadin at baseline are included in the analysis.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	49
Count of Participants [Participants]	12 15.4%

75. Secondary Outcome

Title	Number of Participants Discharged to a Nursing Home or Skilled Nursing Facility or Hospital
Description	Discharge to a nursing home or skilled nursing facility following discharge from the hospital after definitive treatment.
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Count of Participants [Participants]	6 7.7%

76. Secondary Outcome

Title	Post-procedure Length of Hospital Stay
Description	Defined as the number of days from the end of the procedure until the patient is discharged from the hospital. This does not include time in a nursing or skilled care facility.
Time Frame	Length of Hospital Stay, assessed at 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Mean (Standard Deviation) [days]	3.9 (6.4)

77. Secondary Outcome

Title	Post-procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU) Time
Description	Number of hours patients are in an intensive care unit or step down unit before discharge or moving to a standard care unit.
Time Frame	Length of ICU/CCU stay, assessed at 30 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Mean (Standard Deviation) [hours]	52.3 (80.6)

78. Secondary Outcome

Title	Number of Participants With Successful Clip Implant
Description	Rate of successful delivery and deployment of Clip implants with echocardiographic evidence of leaflet approximation and retrieval of the investigational delivery catheter.
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Count of Participants [Participants]	74 94.9%

79. Secondary Outcome

Title	Number of Participants With High Risk Procedural Success
Description	Successful implantation of the Clip (s) with resulting MR severity of 2+ of less at discharge or a 1 grade MR reduction at discharge accompanied by a 1 level reduction in NYHA.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Count of Participants [Participants]	60 76.9%

80. Secondary Outcome

Title	Number of Participants With MR Severity
Description	MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.
Time Frame	Discharge or 30 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	76
0 : None	0 0%
1+: Mild	30 38.5%
2+: Moderate	26 33.3%
3+: Moderate to Severe	14 17.9%
4+: Severe	6 7.7%

81. Secondary Outcome

Title	Number of Participants With MR Severity
Description	MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and MR Severity not done or un-evaluable in 2 patients.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	54
0+: None	0 0%
1+: Mild	17 21.8%
2+: Moderate	25 32.1%
3+: Moderate to Severe	9 11.5%
4+: Severe	3 3.8%

82. Secondary Outcome

Title	Number of Participants With MR Severity
Description	MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 42 participants were included in the analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and MR severity not assessed in 2 patients.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	42
0+: None	0 0%
1+: Mild	14 17.9%
2+: Moderate	23 29.5%
3+: Moderate to Severe	5 6.4%
4+: Severe	0 0%

83. Secondary Outcome

Title	Number of Participants With MR Severity
Description	MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 37 participants were included in the analysis population because of 31 deaths within 3 years, 7 withdrawals, 1 missed visit and MR Severity was not done or un-evaluable in 2 patients.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	37
0+: None	0 0%
1+: Mild	16 20.5%
2+: Moderate	16 20.5%
3+: Moderate to Severe	5 6.4%
4+: Severe	0 0%

84. Secondary Outcome

Title	Number of Participants With MR Severity
Description	MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.
Time Frame	48 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 31 participants were included in the analysis population because of 33 deaths within 3 years, 8 withdrawals, 3 missed visit and MR severity was not done or un-evaluable in 3 patients.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	31
0+: None	0 0%
1+: Mild	18 23.1%
2+: Moderate	9 11.5%
3+: Moderate to Severe	3 3.8%
4+: Severe	1 1.3%

85. Secondary Outcome

Title	Number of Participants With MR Severity
Description	MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.
Time Frame	60 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	24
0+: None	0 0%
1+: Mild	12 15.4%
2+: Moderate	6 7.7%
3+: Moderate to Severe	6 7.7%
4+: Severe	0 0%

86. Secondary Outcome

Title	Number of Participants With Treatment Durability
Description	Defined as the proportion of Acute Procedural Success patients with MR severity grade of 2+ or less that have not required surgery for valve dysfunction.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 56 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals and 1 missed visit.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	56
Count of Participants [Participants]	39 50%

87. Secondary Outcome

Title	Number of Participants With Treatment Durability
Description	Defined as the proportion of Acute Procedural Success patients with MR severity grade of 2+ or less that have not required surgery for valve dysfunction.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

At 24 months, of the 56 patients who achieved acute procedural success, the status of 3 patients is unknown. Among the remaining 53 patients, 30 patients (56.6%) were alive and free from MR > 2+ at 24 months.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	53
Count of Participants [Participants]	30 38.5%

88. Secondary Outcome

Title	Number of Participants With Clinical Durability
Description	Proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

There were 62 patients with an acute reduction in MR severity of at least one grade, and of these, 43 patients met the criterion for clinical durability. The clinical durability rate is therefore 43/62, or 69.4%.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	62
Count of Participants [Participants]	43 55.1%

89. Secondary Outcome

Title	Number of Participants With Clinical Durability
Description	Proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Through 24 months, the clinical durability status of 3 patients is unknown and there were 35 patients with an acute reduction in MR severity from baseline of at least one grade (the one patient who underwent surgery between 12 months and 24 months is not included in the 35 patients).

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	59
Count of Participants [Participants]	35 44.9%

90. Secondary Outcome

Title	Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class
Description	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. They 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	24 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 43 participants were included in the analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and 1 patient without NYHA Class assessment.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	43
NYHA Functional Class I	13 16.7%
NYHA Functional Class II	24 30.8%
NYHA Functional Class III	5 6.4%
NYHA Functional Class IV	1 1.3%

91. Secondary Outcome

Title	Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class
Description	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. They 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	36 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 37 participants were included in analysis population because of 31 deaths within 3 years, 7 withdrawals, 1 missed visit and 2 patients without NYHA Class assessment.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	37
NYHA Functional Class I	10 12.8%
NYHA Functional Class II	20 25.6%
NYHA Functional Class III	7 9%
NYHA Functional Class IV	0 0%

92. Secondary Outcome

Title	Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class
Description	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. They 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	48 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 31 participants were included in the analysis population because of 33 deaths within 3 years, 8 withdrawals, 3 missed visit and NYHA was not assessed in 3 patients.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	31
NYHA Functional Class I	8 10.3%
NYHA Functional Class II	20 25.6%
NYHA Functional Class III	3 3.8%
NYHA Functional Class IV	0 0%

93. Secondary Outcome

Title	Number of Participants With New York Heart Association (NYHA) Class
Description	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. They 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	60 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	24
NYHA Functional Class I	6 7.7%
NYHA Functional Class II	14 17.9%
NYHA Functional Class III	4 5.1%
NYHA Functional Class IV	0 0%

94. Secondary Outcome

Title	Left Ventricular End-diastolic Volume (LVEDV).
Description	Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 39 participants were included in the analysis population because of 26 deaths within 2 year, 7 withdrawals, 1 missed visit and LVEDV was not done or un-evaluable in 5 patients.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	39
Mean (Standard Deviation) [mL]	136.3 (37.8)

95. Secondary Outcome

Title	Left Ventricular End-diastolic Volume (LVEDV).
Description	Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	36
Mean (Standard Deviation) [mL]	135.7 (40.3)

96. Secondary Outcome

Title	Left Ventricular End-diastolic Volume (LVEDV).
Description	Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame	48 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	29
Mean (Standard Deviation) [mL]	139.5 (46.6)

97. Secondary Outcome

Title	Left Ventricular End-diastolic Volume (LVEDV).
Description	Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame	60 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	24
Mean (Standard Deviation) [mL]	133.5 (48.9)

98. Secondary Outcome

Title	Left Ventricular End-systolic Volume (LVESV).
Description	Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 39 participants were included in the analysis population because of 26 deaths within 2 year, 7 withdrawals, 1 missed visit and LVESV was not done or un-evaluable in 5 patients.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	39
Mean (Standard Deviation) [mL]	71.3 (33.4)

99. Secondary Outcome

Title	Left Ventricular End-systolic Volume (LVESV).
Description	Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	36
Mean (Standard Deviation) [mL]	66.4 (33.1)

100. Secondary Outcome

Title	Left Ventricular End-systolic Volume (LVESV).
Description	Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame	48 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	28
Mean (Standard Deviation) [mL]	73.3 (36.9)

101. Secondary Outcome

Title	Left Ventricular End-systolic Volume (LVESV).
Description	Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame	60 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	24
Mean (Standard Deviation) [mL]	67.2 (38)

102. Secondary Outcome

Title	Left Ventricular Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs)
Description	Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 42 participants were included in the analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and LVIDd/LVIDs not done or un-evaluable in 2 patients.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	42
LV Internal Diameter, Diastole (LVIDd)	5.3 (0.8)
LV Internal Diameter, Systole (LVIDs)	4.0 (1.0)

103. Secondary Outcome

Title	Left Ventricular Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs)
Description	Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	37
LV Internal Diameter, Diastole (LVIDd)	5.4 (0.8)
LV Internal Diameter, Systole (LVIDs)	4.1 (1.1)

104. Secondary Outcome

Title	Left Ventricular Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs)
Description	Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame	48 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	31
LV Internal Diameter, Diastole (LVIDd)	5.5 (0.7)
LV Internal Diameter, Systole (LVIDs)	4.0 (1.0)

105. Secondary Outcome

Title	Left Ventricular Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs)
Description	Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame	60 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	24
LV Internal Diameter, Diastole (LVIDd)	5.5 (0.8)
LV Internal Diameter, Systole (LVIDs)	4.2 (1.0)

106. Secondary Outcome

Title	Number of Days Re-hospitalized for CHF
Description	Defined as the number of days hospitalized for CHF in the 12-months prior to the Clip implant procedure date compared to the number of days re-hospitalized for CHF in the 12-months after Clip implant.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

12/75 hospitalized for CHF post-discharge, representing 22 separate hospitalization events with mean of 6.6+/-3.7 days.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	12
Mean (Standard Deviation) [days]	6.6 (3.7)

107. Secondary Outcome

Title	Number of Hospital Re-Admissions for Congestive Heart Failure (CHF)
Description	Defined as the number of hospital admissions (i.e. events) for which the primary diagnosis for hospitalization is congestive heart failure, in the 12-months post-discharge following the MitraClip procedure.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Of 78 patients, 3 patients who died prior to discharge were not included.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	75
Number [Events]	22

108. Secondary Outcome

Title	Regurgitant Volume
Description	Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Of 78 total population, 58 participants were included in the analysis population because of 6 deaths within 30 days and 14 missing data (not done or not evaluable).

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	58
Mean (Standard Deviation) [mL]	25.2 (14.4)

109. Secondary Outcome

Title	Regurgitant Volume
Description	Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 44 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 6 patients Regurgitant volume evaluation was not done or not evaluable.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	44
Mean (Standard Deviation) [mL]	20.4 (15.4)

110. Secondary Outcome

Title	Regurgitant Volume
Description	Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 26 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and 18 patients were without Regurgitant Volume assessment.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	26
Mean (Standard Deviation) [mL]	19.9 (10.7)

111. Secondary Outcome

Title	Regurgitant Fraction (RF)
Description	RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Of 78 total population, 58 participants were analysed as 6 participants died within 30 days and 14 missing data (not done or not evaluable).

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	58
Mean (Standard Deviation) [percentage of LV stroke volume]	32.1 (15.2)

112. Secondary Outcome

Title	Regurgitant Fraction
Description	RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 44 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 6 patients Regurgitant fraction evaluation was not done or not evaluable.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	44
Mean (Standard Deviation) [percentage of LV stroke volume]	26.3 (16.5)

113. Secondary Outcome

Title	Regurgitant Fraction
Description	RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 26 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and 18 patients were without Regurgitant fraction assessment.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	26
Mean (Standard Deviation) [percentage of LV stroke volume]	27.4 (13.0)

114. Secondary Outcome

Title	Cardiac Output (CO)
Description	CO is defined as the volume of blood pumped by the left ventricle per unit time (L/min).
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

Of 78 total population, 66 participants were included in analysis population because of 6 deaths within 30 days and in 6 patients Cardiac Output was not assessed or or un-evaluable.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	66
Mean (Standard Deviation) [l/min]	3.8 (1.2)

115. Secondary Outcome

Title	Cardiac Output
Description	CO is defined as the volume of blood pumped by the left ventricle per unit time (L/min)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Cardiac output evaluation was not done or un-evaluable.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	53
Mean (Standard Deviation) [l/min]	3.8 (1.0)

116. Secondary Outcome

Title	Cardiac Output
Description	CO is defined as the volume of blood pumped by the left ventricle per unit time (L/min)
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 40 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients Cardiac output evaluation was not done or un-evaluable.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	40
Mean (Standard Deviation) [l/min]	3.5 (0.9)

117. Secondary Outcome

Title	Cardiac Index
Description	Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

Of 78 total population, 66 participants were included in the analysis population because of 6 deaths within 30 days and in 6 participants cardiac Index was un-evaluable or not done.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	66
Mean (Standard Deviation) [l/min/m2]	2 (0.6)

118. Secondary Outcome

Title	Cardiac Index
Description	Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Cardiac Index evaluation was not done or un-evaluable.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	53
Mean (Standard Deviation) [l/min/m2]	2 (0.5)

119. Secondary Outcome

Title	Cardiac Index
Description	Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Of 78 total population, 40 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients cardiac index evaluation was not done or un-evaluable.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	40
Mean (Standard Deviation) [l/min/m2]	1.8 (0.4)

120. Secondary Outcome

Title	Left Ventricular Ejection Fraction (LVEF)
Description	Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.
Time Frame	Discharge or 30 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	75
Mean (Standard Deviation) [percentage of ejection fraction]	52.3 (12.4)

121. Secondary Outcome

Title	Left Ventricular Ejection Fraction (LVEF)
Description	Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	54
Mean (Standard Deviation) [percentage of ejection fraction]	50.2 (13.1)

122. Secondary Outcome

Title	Left Ventricular Ejection Fraction (LVEF)
Description	Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	39
Mean (Standard Deviation) [percentage of ejection fraction]	49.5 (12)

123. Secondary Outcome

Title	Left Ventricular Ejection Fraction (LVEF)
Description	Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	36
Mean (Standard Deviation) [percentage of ejection fraction]	52.5 (12.5)

124. Secondary Outcome

Title	Left Ventricular Ejection Fraction (LVEF)
Description	Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.
Time Frame	48 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	28
Mean (Standard Deviation) [percentage of ejection fraction]	49.9 (12.6)

125. Secondary Outcome

Title	Left Ventricular Ejection Fraction (LVEF)
Description	Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.
Time Frame	60 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	24
Mean (Standard Deviation) [percentage of ejection fraction]	51.5 (13.6)

126. Secondary Outcome

Title	Percentage of Participants With Freedom From Mitral Valve Surgery
Description	Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Number [percentage of participants]	100 128.2%

127. Secondary Outcome

Title	Percentage of Participants With Freedom From Mitral Valve Surgery
Description	Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Analysis population includes 58 participants, which represents the number of patients at risk as per Kaplan-Meier freedom from Mitral valve (MV)surgery analysis at 12 months.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	58
Number [percentage of participants]	100 128.2%

128. Secondary Outcome

Title	Percentage of Participants With Freedom From Mitral Valve Surgery
Description	Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Analysis population includes 45 participants, which represents the number of patients at risk as per Kaplan-Meier analysis at 24 months.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	45
Number [percentage of participants]	98.1 125.8%

129. Secondary Outcome

Title	Percentage of Participants With Freedom From Mitral Valve Surgery
Description	Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

Analysis population includes 39 participants, which represents the number of patients at risk as per Kaplan-Meier analysis at 36 months.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	39
Number [percentage of participants]	98.1 125.8%

130. Secondary Outcome

Title	Percentage of Participants With Freedom From Mitral Valve Surgery
Description	Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure
Time Frame	48 months

Outcome Measure Data

Analysis Population Description

Analysis population includes 35 participants, which represents the number of patients at risk as per Kaplan-Meier analysis at 48 months.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	35
Number [percentage of participants]	95.5 122.4%

131. Secondary Outcome

Title	Percentage of Participants With Freedom From Mitral Valve Surgery
Description	Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure
Time Frame	60 months

Outcome Measure Data

Analysis Population Description

Analysis population includes 14 participants, which represents the number of patients at risk as per Kaplan-Meier analysis at 60 months.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	14
Number [percentage of participants]	95.5 122.4%

132. Secondary Outcome

Title	Number of Participants With Mitral Valve Repair Success
Description	Mitral Valve Repair Success defined as freedom from mitral valve replacement surgery for valve dysfunction, death, re-operation and MR > 2+ at 12 months.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Count of Participants [Participants]	44 56.4%

133. Secondary Outcome

Title	Number of Participants With Mitral Valve Repair Success
Description	Freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Three Acute Procedural Success (APS) patients withdrew at or before 12 months, and had MR ≤ 2+ at all visits prior to withdrawal. Since there is no data on these patients post-12 months, these patients are not included in the endpoint of freedom from mitral valve replacement surgery for Valve Dysfunction, death and MR > 2+ at 24 months.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	75
Count of Participants [Participants]	37 47.4%

134. Secondary Outcome

Title	Composite Functional and Structural Measures - Percentage of Participants With Freedom From Death
Description	Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint. Death is further divided into 2 categories: A. Cardiac death is defined as death due to any of the following: Acute myocardial infarction. Cardiac perforation/pericardial tamponade. Arrhythmia or conduction abnormality. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure. Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery. Any death for which a cardiac cause cannot be excluded. B. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Analysis population includes 46 participants, which represents the number of patients at risk as per Kaplan-Meier freedom from mortality analysis at 24 months.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	46
Number [percentage of participants]	64.6 82.8%

135. Secondary Outcome

Title	Percentage of Participants With Composite Functional and Structural Measures - Freedom From Death and MR >2+
Description	Kaplan-Meier estimated proportion of patients who are alive and have a mitral regurgitation severity grade of 2+ or less.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Primary Analysis at 24 months included only 75 patients. Three patients were excluded due to withdrawal at or before 12 months.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Primary Analysis	49.3 63.2%
Worstcase Analysis	46.2 59.2%

136. Secondary Outcome

Title	Number of Participants With Device Embolization or Single Leaflet Device Attachment
Description	Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets. A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.
Time Frame	0 to 12 months

Outcome Measure Data

Analysis Population Description

Three patients were excluded from the analysis as they did not receive a Device.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	75
Device Embolization	0 0%
Single Leaflet Device Attachment	1 1.3%

137. Secondary Outcome

Title	Number of Participants With Device Embolization or Single Leaflet Device Attachment
Description	Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets. A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Patients implanted with a MitraClip device, alive were evaluated at 24 months.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	46
Device Embolization	0 0%
Single Leaflet Device Attachment	0 0%

138. Secondary Outcome

Title	Number of Participants With Device Embolization or Single Leaflet Device Attachment
Description	Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets. A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.
Time Frame	48 months

Outcome Measure Data

Analysis Population Description

Patients implanted with a MitraClip device and alive were evaluated at 48 months.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	31
Device Embolization	0 0%
Single Leaflet Device Attachment	0 0%

139. Secondary Outcome

Title	Number of Participants With Device Embolization or Single Leaflet Device Attachment
Description	Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets. A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

Patients implanted with a MitraClip device, alive were evaluated at 36 months.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	39
Device Embolization	0 0%
Single Leaflet Device Attachment	0 0%

140. Secondary Outcome

Title	Number of Participants With Device Embolization or Single Leaflet Device Attachment
Description	Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets. A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.
Time Frame	60 months

Outcome Measure Data

Analysis Population Description

Patients implanted with a MitraClip device and alive were evaluated at 60 months.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	30
Device Embolization	0 0%
Single Leaflet Device Attachment	0 0%

141. Secondary Outcome

Title	Number of Participants With Mitral Valve Surgery Post-MitraClip Procedure
Description	Number of patients who underwent surgical mitral valve repair or replacement after the index MitraClip procedure.
Time Frame	60 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	30
Count of Participants [Participants]	2 2.6%

142. Secondary Outcome

Title	Number of Participants With Second MitraClip Device Implanted
Description	It is a summary of re-interventions to place an additional MitraClip Device.
Time Frame	0 to 5 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	30
Count of Participants [Participants]	2 2.6%

143. Secondary Outcome

Title	Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery
Description	Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	58
Number [percentage of participants]	75.6 96.9%

144. Secondary Outcome

Title	Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery
Description	Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	45
Number [percentage of participants]	63.2 81%

145. Secondary Outcome

Title	Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery
Description	Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	39
Number [percentage of participants]	57.4 73.6%

146. Secondary Outcome

Title	Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery
Description	Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure
Time Frame	48 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	35
Number [percentage of participants]	51.5 66%

147. Secondary Outcome

Title	Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery
Description	Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure
Time Frame	60 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	14
Number [percentage of participants]	41.2 52.8%

148. Secondary Outcome

Title	Number of Participants With Mitral Valve Replacement
Description	Defined as how often patients receiving surgery required replacement of the mitral valve.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Count of Participants [Participants]	2 2.6%

149. Secondary Outcome

Title	Number of Participants With Mitral Valve Replacement
Description	Defined as how often patients receiving surgery required replacement of the mitral valve.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Count of Participants [Participants]	1 1.3%

150. Secondary Outcome

Title	Number of Participants With Mitral Valve Replacement
Description	Defined as how often patients receiving surgery required replacement of the mitral valve.
Time Frame	36 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Count of Participants [Participants]	2 2.6%

151. Secondary Outcome

Title	Number of Participants With Mitral Valve Replacement
Description	Defined as how often patients receiving surgery required replacement of the mitral valve.
Time Frame	48 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Measure Participants	78
Count of Participants [Participants]	2 2.6%

Adverse Events

Time Frame	5 years
Arm/Group Title	High Risk Registry Arm
Arm/Group Description	Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant. Percutaneous mitral valve repair using MitraClip implant: Procedure/Surgery: Mitral valve repair or replacement surgery Repair or replacement of mitral valve
All Cause Mortality
	High Risk Registry Arm
	Affected / at Risk (%)	# Events
Total	25/78 (32.1%)
Serious Adverse Events
	High Risk Registry Arm
	Affected / at Risk (%)	# Events
Total	69/78 (88.5%)
Blood and lymphatic system disorders
Anemia	9/78 (11.5%)
Coagulopathy	2/78 (2.6%)
Hematologic - Other	2/78 (2.6%)
Infection/Bacteremia/Septicemia	6/78 (7.7%)
Thrombocytopenia	1/78 (1.3%)
Cardiac disorders
Atrial arrhythmia	9/78 (11.5%)
Atrial septal defect	1/78 (1.3%)
Bradyarrhythmia	2/78 (2.6%)
Cardiac arrest	3/78 (3.8%)
Cardiac disorders: Other	2/78 (2.6%)
Cardiogenic shock	1/78 (1.3%)
Cardiomyopathy	1/78 (1.3%)
Chest pain/Angina	9/78 (11.5%)
Congestive heart failure	21/78 (26.9%)
Coronary artery disease	2/78 (2.6%)
Endocarditis	2/78 (2.6%)
Heart block	3/78 (3.8%)
Lead displacement	2/78 (2.6%)
Myocardial infarction	7/78 (9%)
Myocardial ischemia	1/78 (1.3%)
Other rhythm disorder	7/78 (9%)
Palpitations	1/78 (1.3%)
Residual/Recurrent MR	1/78 (1.3%)
Supraventricular arrhythmia	1/78 (1.3%)
Syncope/Dizziness	2/78 (2.6%)
Tamponade	1/78 (1.3%)
Ventricular arrhythmia	3/78 (3.8%)
Gastrointestinal disorders
Abdominal pain	4/78 (5.1%)
Bleed	9/78 (11.5%)
Gastrointestinal disorders: Other	9/78 (11.5%)
Infection	1/78 (1.3%)
General disorders
Death	25/78 (32.1%)
General disorders: Other	11/78 (14.1%)
Generalized weakness/Fatigue	2/78 (2.6%)
Infection	7/78 (9%)
Metabolic/Endocrine disorders	7/78 (9%)
Musculoskeletal and connective tissue disorders
Connective tissue disorders	8/78 (10.3%)
Nervous system disorders
Intracerebral hemorrhage	5/78 (6.4%)
Nervous system disorders: Other	6/78 (7.7%)
Neurologic - Stroke	1/78 (1.3%)
Transient ischemic attack (TIA)	6/78 (7.7%)
Renal and urinary disorders
Renal Infection	9/78 (11.5%)
Renal and urinary disorders: Other	2/78 (2.6%)
Renal insufficiency/Failure	20/78 (25.6%)
Respiratory, thoracic and mediastinal disorders
Bronchial/lung disorders	1/78 (1.3%)
Chronic Obstructive Pulmonary Disease (COPD)	2/78 (2.6%)
Pleural effusion	7/78 (9%)
Pneumonia	7/78 (9%)
Pulmonary edema	5/78 (6.4%)
Pulmonary hypertension	1/78 (1.3%)
Respiratory - Other	11/78 (14.1%)
Respiratory Infection	2/78 (2.6%)
Respiratory failure	11/78 (14.1%)
Vascular disorders
Arteriovenous (AV) fistula	2/78 (2.6%)
Bleeding complication	5/78 (6.4%)
Deep vein thrombosis (DVT)	1/78 (1.3%)
Embolization	1/78 (1.3%)
Hemodynamic instability	9/78 (11.5%)
Pseudoaneurysm	2/78 (2.6%)
Shock	1/78 (1.3%)
Vascular Injury	1/78 (1.3%)
Vascular disorders: Other	7/78 (9%)
Other (Not Including Serious) Adverse Events
	High Risk Registry Arm
	Affected / at Risk (%)	# Events
Total	77/78 (98.7%)
Blood and lymphatic system disorders
Anemia	26/78 (33.3%)
Hemolysis	11/78 (14.1%)
Thrombocytopenia	6/78 (7.7%)
Cardiac disorders
Atrial arrhythmia	10/78 (12.8%)
Atrial septal defect	4/78 (5.1%)
Bradyarrhythmia	4/78 (5.1%)
Cardiac disorders: other	4/78 (5.1%)
Chest pain/Angina	22/78 (28.2%)
Congestive heart failure	19/78 (24.4%)
Myocardial ischemia	9/78 (11.5%)
Other rhythm disorder	8/78 (10.3%)
Peripheral edema	20/78 (25.6%)
Residual/recurrent magnetic resonance (MR)	15/78 (19.2%)
Syncope/Dizziness	19/78 (24.4%)
Ventricular arrhythmia	6/78 (7.7%)
cardiomyopathy	4/78 (5.1%)
Gastrointestinal disorders
Abdominal pain	4/78 (5.1%)
Bleed	4/78 (5.1%)
Dysphagia	8/78 (10.3%)
Gastrointestinal disorders: Other	30/78 (38.5%)
Infection	8/78 (10.3%)
General disorders
Fever	6/78 (7.7%)
General disorders: Other	38/78 (48.7%)
Generalized weakness/Fatigue	24/78 (30.8%)
Incisional site pain	13/78 (16.7%)
Infection	6/78 (7.7%)
Mental disorders	14/78 (17.9%)
Metabolic/Endocrine disorders	26/78 (33.3%)
Skin/Mucosal/Subcutaneous tissue disorders	10/78 (12.8%)
Musculoskeletal and connective tissue disorders
Connective tissue disorders	37/78 (47.4%)
Nervous system disorders
Nervous system disorders: Other	18/78 (23.1%)
Transient ischemic attack (TIA)	4/78 (5.1%)
Renal and urinary disorders
Renal Infection	10/78 (12.8%)
Renal and urinary disorders: Other	12/78 (15.4%)
Renal insufficiency/Failure	15/78 (19.2%)
Respiratory, thoracic and mediastinal disorders
Bronchial/Lung disorders	8/78 (10.3%)
Pleural effusion	16/78 (20.5%)
Pneumonia	6/78 (7.7%)
Respiratory Infection	9/78 (11.5%)
Respiratory failure	5/78 (6.4%)
Respiratory, thoracic and mediastinal disorders: Other	30/78 (38.5%)
Vascular disorders
Bleeding complication	34/78 (43.6%)
Blood pressure complication	4/78 (5.1%)
Bruise/Contusion/Ecchymosis	18/78 (23.1%)
Hematoma	19/78 (24.4%)
Hemodynamic instability	21/78 (26.9%)
Vascular disorders: Other	8/78 (10.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.