EVERESTIIRCT: Pivotal Study of a Percutaneous Mitral Valve Repair System

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00209274
• Collaborator: (none)
• Enrollment: 279
• Location: 1
• Arms: 2
• Duration (Months): 112
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

EVEREST II Randomized Controlled Trial (RCT) is a prospective, multi-center, randomized study of the MitraClip® System in the treatment of mitral valve regurgitation, randomizing patients to MitraClip or mitral valve surgery. The EVEREST II High Risk Registry (HRR) study is a prospective multi-center study of the MitraClip System for the treatment of mitral valve regurgitation in high surgical risk patients. Enrollment in the RCT and HRR is closed. A continued access prospective, multi-center study (REALISM) of the MitraClip System in a surgical population (non-high risk arm) and a high surgical risk population (high risk arm) is ongoing. Enrollment in the non-high risk arm of REALISM is closed. Enrollment in the high risk arm of REALISM is ongoing. Patients enrolled in EVEREST II undergo 30-day, 6-month, 12-month, 18-month and 24-month clinical and echocardiographic follow-up, and then annually for 5 years.

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; Procedure: Mitral valve repair or replacement surgery	N/A

Detailed Description

Prospective, multi-center, randomized study of the safety and effectiveness of an endovascular approach to the treatment of mitral valve regurgitation using the Evalve Cardiovascular Valve Repair System (MitraClip® implant).

A minimum of 279 evaluable patients randomized 2:1 to MitraClip or mitral valve surgery, respectively, are required to test the primary safety and effectiveness endpoints of the RCT. Enrollment in the RCT is now complete. 60 roll-in patients were enrolled under EVEREST II RCT.

38 clinical sites throughout the US and Canada have participated in the RCT and HRR. 37 US sites are participating in REALISM.

The RCT is powered to test the hypothesis MitraClip has both superiority of safety and non-inferiority of effectiveness compared to mitral valve repair or replacement surgery. The HRR is powered to show lower mortality at 30 days with the MitraClip than predicted surgical mortality.

Study Design

• Study Type: Interventional
• Actual Enrollment: 279 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pivotal Study: A Study of the Evalve Cardiovascular Valve Repair System - Endovascular Valve Edge-to-Edge REpair STudy (EVERESTIIRCT)
• Study Start Date: Aug 1, 2005
• Actual Primary Completion Date: Nov 1, 2009
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Percutaneous mitral valve repair using MitraClip implant. The calculated sample size was 186 patients in the device arm	Device: Percutaneous mitral valve repair using MitraClip implant; MitraClip Implant; Other Names: MitraClip
Active Comparator: 2 Mitral valve repair or replacement surgery. The calculated sample size was 93 patients in the control arm.	Procedure: Mitral valve repair or replacement surgery; Repair or replacement of mitral valve

Outcome Measures

Primary Outcome Measures

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

   Defined as a 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, gastrointestinal (GI) complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.

2. Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR). [12 months]

Secondary Outcome Measures

1. Freedom From All-Cause Mortality [12 months]

2. Freedom From All-Cause Mortality [24 months]

3. Freedom From All-Cause Mortality [3 years]

4. Freedom From All-Cause Mortality [4 years]

5. Freedom From All-Cause Mortality [5 years]

6. Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation. [12 months]

7. Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR). [24 months]

8. Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR) in Intention to Treat Strategy Cohort [24 months]

9. Left Ventricular Ejection Fraction (LVEF) [At discharge (≤ 14 days following index procedure) or 30 days]

   LVEF as determined by the core echo laboratory at 30 days or hospital discharge, whichever is longer.

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

    LVEF as determined by the core echo laboratory.

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

    LVEF as determined by the core echo laboratory.

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

    LVEF as determined by the core echo laboratory.

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

    LVEF as determined by the core echo laboratory.

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

    LVEF as determined by the core echo laboratory.

15. Left Ventricular Status- Left Ventricular End-diastolic Volume (LVEDV), Left Ventricular End-systolic Volume (LVESV) [30 days]

    Left Ventricular Status includes Left ventricular (LV) end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 30 days or hospital discharge, whichever is longer.

16. Left Ventricular Status- LVEDV, LVESV [12 months]

    Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV),as determined by the core echo laboratory at 12 months.

17. Left Ventricular Status- LVEDV, LVESV [24 months]

    Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 24 months.

18. Left Ventricular Status- LVEDV, LVESV [3 years]

    Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 3 years.

19. Left Ventricular Status- LVEDV, LVESV [4 years]

    Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 4 years

20. Left Ventricular Status- LVEDV, LVESV [5 years]

    Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 5 years.

21. Left Ventricular Internal Dimension Systole (LVIDs) [30 days]

    Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.

22. Left Ventricular Internal Dimension Systole (LVIDs) [12 months]

    Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.

23. Left Ventricular Internal Dimension Systole (LVIDs) [2 years]

    Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.

24. Left Ventricular Internal Dimension Systole (LVIDs) [3 years]

    Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.

25. Left Ventricular Internal Dimension Systole (LVIDs) [4 years]

    Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.

26. Left Ventricular Internal Dimension Systole (LVIDs) [5 years]

    Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.

27. Left Ventricular Internal Dimension Diastole (LVIDd) [30 days]

    Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory.

28. Left Ventricular Internal Dimension Diastole (LVIDd) [12 months]

    Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 12 months.

29. Left Ventricular Internal Dimension Diastole (LVIDd) [24 months]

    Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 24 months.

30. Left Ventricular Internal Dimension Diastole (LVIDd) [3 years]

    Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 3 years.

31. Left Ventricular Internal Dimension Diastole (LVIDd) [4 years]

    Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 4 years.

32. Left Ventricular Internal Dimension Diastole (LVIDd) [5 years]

    Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 5 years.

33. Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. [Baseline]

    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.

34. Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. [30 days]

    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.

35. Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. [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.

36. Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. [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.

37. Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. [3 years]

    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.

38. Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. [4 years]

    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.

39. Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. [5 years]

    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.

40. New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV [30 days]

    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.

41. Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV [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.

42. Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV [2 years]

    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.

43. Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV [3 years]

    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.

44. Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV [4 years]

    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.

45. Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV [5 years]

    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.

46. Short Form (SF)-36 Quality of Life Questionnaire. [30 days]

    The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score) & mental health status (Mental Component Score) in relation to 8 health concepts: physical functioning, role limitations due to physical or emotional health, bodily pain, general health perceptions, vitality, social functioning, & general mental health. Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health. The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively.

47. Short Form (SF)-36 Quality of Life Questionnaire. [12 months]

    The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score) & mental health status (Mental Component Score) in relation to 8 health concepts: physical functioning, role limitations due to physical or emotional health, bodily pain, general health perceptions, vitality, social functioning, & general mental health. Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health. The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively.

48. Cardiac Output [30 days]

    Cardiac output as measured by core lab echocardiography.

49. Cardiac Output [12 months]

    Cardiac output as measured by core lab echocardiography.

50. Cardiac Output [24 months]

    Cardiac output as measured by core lab echocardiography.

51. Cardiac Index [30 days]

    Defined as cardiac output divided by body surface area, as measured by core lab echocardiography.

52. Cardiac Index (CI) [12 months]

    Defined as cardiac output divided by body surface area as measured by core lab echocardiography. CI is a normalization of cardiac output to take into account the effect of body size on cardiac output requirements.

53. Cardiac Index [24 months]

    Defined as cardiac output divided by body surface area, as measured by core lab echocardiography.

54. Regurgitant Volume [30 Days]

    Regurgitant volume as determined by the core echo laboratory. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.

55. Regurgitant Volume [12 months]

    Regurgitant volume as determined by the core echo laboratory.

56. Regurgitant Volume [24 months]

    Regurgitant volume as determined by the core echo laboratory.

57. Regurgitant Fraction (RF) [30 Days]

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

58. Regurgitant Fraction [12 months]

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

59. Regurgitant Fraction [24 months]

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

60. Number of Participants With Clip Implant Rate [Day 0]

    Defined as the rate of successful implantation of MitraClip(s).

61. Number of Participants With Acute Procedural Success [30 Days]

    Defined as successful MitraClip implantation with resulting MR of 2+ or less.

62. Number of Participants With Acute Surgical Success [30 Days]

    Defined as successful mitral valve repair or replacement surgery.

63. Number of Participants With Successful Clip Implant and Acute Procedural Success [30 days]

    Acute procedural success is defined as MR severity ≤ 2 at discharge or 1 grade MR reduction at discharge accompanied by 1 level NYHA reduction.

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

    Defined as freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+ at 12 months.

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

    Defined as freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+ at 12 months.

66. Number of Participants With Procedural Freedom From In-hospital MAE. [Day 0]

67. Number of Participants With Procedural Freedom From In-hospital MAE [Day 30]

68. Number of Participants With MAE: Surgery After Device and First Time Surgery Control [30 days]

69. Number of Participants With Major Vascular Complications [30 days]

    Vascular Complications defined as the occurrence of any of the following resulting through 30 days or hospital discharge, whichever is longer: Hematoma at access site >6 cm; Retroperitoneal hematoma; Arteriovenous (AV) fistula; Symptomatic peripheral ischemia / nerve injury or the clinical signs or symptoms lasting >48 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.

70. Number of Participants With Major Vascular Complications [12 months]

    Vascular Complications defined as the occurrence of any of the following resulting through 30 days or hospital discharge, whichever is longer: Hematoma at access site >6 cm; Retroperitoneal hematoma; Arteriovenous (AV) fistula; Symptomatic peripheral ischemia / nerve injury or the clinical signs or symptoms lasting >48 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.

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

    Major Bleeding Complications defined as procedure related bleeding that requires a transfusion of ≥2 units of blood products and/or surgical intervention at 30 days or hospital discharge, whichever is longer.

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

    Major Bleeding Complications defined as procedure related bleeding that requires a transfusion of ≥2 units of blood products and/or surgical intervention at 12 months.

73. Number of Participants With Major Adverse Events (MAE) [12 months.]

74. Number of Participants With MAE in Patients Over 75 Years of Age. [30 days]

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

76. Number of Participants With Dysrhythmia [30 days]

77. Number of Participants With Dysrhythmia [12 months]

78. Number of Participants With Endocarditis. [30 days]

    Defined as a diagnosis of endocarditis based on the Duke criteria. Infection in the lining of the heart, of the valves, or of the muscles of the heart. Signs of endocarditis may include persistent positive blood cultures and/or valvular structural abnormality and vegetations as seen using echocardiography.

79. Number of Participants With Endocarditis. [12 months]

    Defined as a diagnosis of endocarditis based on the Duke criteria. Infection in the lining of the heart, of the valves, or of the muscles of the heart. Signs of endocarditis may include persistent positive blood cultures and/or valvular structural abnormality and vegetations as seen using echocardiography.

80. Number of Participants With Thrombosis. [30 days]

    Defined as evidence of the formation of an independently moving thrombus on any part of the MitraClip or any commercially available implant used during surgery by echocardiography or fluoroscopy.

81. Number of Participants With Thrombosis. [12 months]

    Defined as evidence of the formation of an independently moving thrombus on any part of the MitraClip or any commercially available implant used during surgery by echocardiography or fluoroscopy.

82. 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 repeat measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms. Reported as major or minor as defined below: Major: Requires intervention with red blood cell transfusion or other hematocrit increasing measures in the absence of other obvious bleeding. Minor: Does not require intervention.

83. 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 repeat measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms. Reported as major or minor as defined below: Major: Requires intervention with red blood cell transfusion or other hematocrit increasing measures in the absence of other obvious bleeding. Minor: Does not require intervention.

84. Number of Participants With Clinically Significant Atrial Septal Defect (ASD). [30 days]

    Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.

85. Number of Participants With Clinically Significant Atrial Septal Defect (ASD) [12 months]

    Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.

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

    Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.

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

    Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.

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

    Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.

89. Number of Participants With Mitral Valve Stenosis [3 years]

    Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography. A "confirmed" case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area < 1.5 cm^2. A "conservative" case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.

90. Number of Participants With Mitral Valve Stenosis [4 years]

    Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography. A "confirmed" case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area < 1.5 cm^2. A "conservative" case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.

91. Number of Participants With Mitral Valve Stenosis [5 years]

    Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography. A "confirmed" case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area < 1.5 cm^2. A "conservative" case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.

92. Mitral Valve Area by Planimetry [At Discharge (≤14 days of index procedure)]

    Mitral valve area as measured by core lab echocardiography.

93. Mitral Valve Area by Planimetry [30 Days]

    Mitral valve area as measured by core lab echocardiography.

94. Mitral Valve Area by Planimetry [12 months]

    Mitral valve area as measured by core lab echocardiography.

95. Mitral Valve Area by Planimetry [24 months]

    Mitral valve area as measured by core lab echocardiography.

96. Mitral Valve Area by Planimetry [3 years]

    Mitral valve area as measured by core lab echocardiography.

97. Mitral Valve Area by Planimetry [4 years]

    Mitral valve area as measured by core lab echocardiography.

98. Mitral Valve Area by Planimetry [5 years]

    Mitral valve area as measured by core lab echocardiography.

99. Mitral Valve Area by Planimetry Index [30 Days]

    Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.

100. Mitral Valve Area by Planimetry Index [12 months]

     Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.

101. Mitral Valve Area by Planimetry Index [24 months]

     Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.

102. Mitral Valve Area by Pressure Half-time [At Discharge (≤14 days of index procedure)]

     Mitral valve area as measured by core lab echocardiography.

103. Mitral Valve Area by Pressure Half-time [30 days]

     Mitral valve area as measured by core lab echocardiography.

104. Mitral Valve Area by Pressure Half-time [12 months]

     Mitral valve area as measured by core lab echocardiography.

105. Mitral Valve Area by Pressure Half-time [24 months]

     Mitral valve area as measured by core lab echocardiography.

106. Mitral Valve Area by Pressure Half-time [3 years]

     Mitral valve area as measured by core lab echocardiography.

107. Mitral Valve Area by Pressure Half-time [4 years]

     Mitral valve area as measured by core lab echocardiography.

108. Mitral Valve Area by Pressure Half-time [5 years]

     Mitral valve area as measured by core lab echocardiography.

109. Mitral Valve Area by Pressure Half-time Index [30 Days]

     Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.

110. Mitral Valve Area by Pressure Half-time Index [12 months]

     Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.

111. Mitral Valve Area by Pressure Half-time Index [24 months]

     Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.

112. Transvalvular Mitral Valve Gradient [At Discharge (≤ 14 days following index procedure)]

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

113. Transvalvular Mitral Mean Pressure Gradient (Mean MVG) [12 months]

     Defined as the mean pressure gradient across the mitral valve as measured by Echocardiography Core Laboratory (ECL).

114. Transvalvular Mitral Mean Pressure Gradient (Mean MVG) [24 months]

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

115. Transvalvular Mitral Mean Pressure Gradient (Mean MVG) [3 year]

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

116. Transvalvular Mitral Mean Pressure Gradient (Mean MVG) [4 year]

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

117. Transvalvular Mitral Mean Pressure Gradient (Mean MVG) [5 years]

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

118. Post-procedure Length of Hospital Stay [30 Days]

119. Post-procedure Intensive Care Unit (ICU) / Critical Care Unit (CCU) Duration [30 Days]

120. Number of Participants With Hospital Re-admissions [30 days]

     Defined as re-admission to the hospital for any reason. The endpoint was intended to capture each time a patient was re-admitted to the hospital for any reason and was to be reported as a rate through 30 days for both the Device and Control groups.

121. Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility/Hospital [30 Days]

122. Number of Participants With Incidence of Hospital Readmissions for Congestive Heart Failure (CHF). [30 days]

123. Number of Participants With New Coumadin (Warfarin) Usage [30 days]

124. Number of Participants With New Coumadin (Warfarin) Usage [12 months]

125. Number of Participants With Durability of the MitraClip Device and Surgery. [12 months]

     Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval. Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.

126. Number of Participants With Durability of the MitraClip Device and Surgery. [12-18 months]

     Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval. Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.

127. Number of Participants With Durability of the MitraClip Device and Surgery. [18-24 months]

     Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval. Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.

128. Number of Participants With Durability of the MitraClip Device and Surgery. [24 months-3 year]

     Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval. Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.

129. Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+ [12 months]

     Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+

130. Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+ [24 months]

     Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+

131. Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+ [3 years]

     Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+

132. Number of Participants With Freedom From Mitral Valve Surgery/Re-operation [12 months]

     Durability estimates: Freedom from Mitral Valve Surgery/Re-operation

133. Number of Participants With Freedom From Mitral Valve Surgery/Re-operation [24 months]

     Durability estimates: Freedom from Mitral Valve Surgery/Re-operation

134. Number of Participants With Freedom From Mitral Valve Surgery/Re-operation [3 years]

     Durability estimates: Freedom from Mitral Valve Surgery/Re-operation

135. Number of Participants With Freedom From Mitral Valve Surgery/Re-operation [4 years]

     Durability estimates: Freedom from Mitral Valve Surgery/Re-operation

136. Number of Participants With Freedom From Mitral Valve Surgery/Re-operation [5 years]

     Durability estimates: Freedom from Mitral Valve Surgery/Re-operation

137. Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation [12 months]

     Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation

138. Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation [24 months]

     Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation

139. Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation [3 years]

     Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation

140. Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation [4 years]

     Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation

141. Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation [5 years]

     Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation

142. Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment [12 months]

     Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device.

143. Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment [12 months to 3 years]

     Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device

144. Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment [12 months to 4 years]

     Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device

145. Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment [12 months to 5 years]

     Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device

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

     Defined as any thrombus or thromboembolism in the vasculature (excluding central nervous system events) or on the investigational device or any commercially available implant used during surgery confirmed by standard clinical and laboratory testing and which requires treatment.

147. Number of Participants With MR Severity [30 days]

     MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe. "Discharge" refers to each individual patient's date of hospital discharge. The discharge date varies for each patient, but in general, discharge occurs before 30-days follow-up. A 30-day echocardiogram will be used if the discharge echocardiogram is unavailable or otherwise uninterpretable.

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

     MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe

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

     MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe

150. Number of Participants With MR Severity [3 years]

     MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe

151. Number of Participants With MR Severity [4 years]

     MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe

152. Number of Participants With MR Severity [5 years]

     MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe

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

     Defined as any thrombus or thromboembolism in the vasculature (excluding central nervous system events) or on the investigational device or any commercially available implant used during surgery confirmed by standard clinical and laboratory testing and which requires treatment.

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

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

Eligibility Criteria

Criteria

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

Key Inclusion/Exclusion Criteria:

Patients with Grade 3 (moderate to severe) or Grade 4 (severe) mitral regurgitation (MR) based on American Society of Echocardiography guidelines:

• Are 18 years or older.

• Symptomatic

• If asymptomatic, must have new onset of atrial fibrillation, pulmonary hypertension, or evidence of left ventricular dysfunction

• Are candidates for mitral valve surgery

• Are candidates for transseptal catheterization

• Primary regurgitant jet must originate from malcoaptation of the A2 and P2 scallops of the mitral valve

• Appropriate valve anatomy for MitraClip

• Does not need other cardiac surgery or any emergency surgery

• Did not experience myocardial infarction in prior 12 weeks or endovascular procedure in prior 30 days

• Mitral valve orifice area ≥ 4 cm2

• Do not have renal insufficiency

• Echocardiographic evidence of intracardiac mass, thrombus or vegetation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Evanston Northwestern Healthcare	Evanston	Illinois	United States	60201

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Argenziano M, Skipper E, Heimansohn D, Letsou GV, Woo YJ, Kron I, Alexander J, Cleveland J, Kong B, Davidson M, Vassiliades T, Krieger K, Sako E, Tibi P, Galloway A, Foster E, Feldman T, Glower D; EVEREST Investigators. Surgical revision after percutaneous mitral repair with the MitraClip device. Ann Thorac Surg. 2010 Jan;89(1):72-80; discussion p 80. doi: 10.1016/j.athoracsur.2009.08.063.
• Biner S, Siegel RJ, Feldman T, Rafique AM, Trento A, Whitlow P, Rogers J, Moon M, Lindman B, Zajarias A, Glower D, Kar S; EVEREST investigators. Acute effect of percutaneous MitraClip therapy in patients with haemodynamic decompensation. Eur J Heart Fail. 2012 Aug;14(8):939-45. Epub 2012 May 14.
• Borgia F, Di Mario C, Franzen O. Adenosine-induced asystole to facilitate MitraClip placement in a patient with adverse mitral valve morphology. Heart. 2011 May;97(10):864. doi: 10.1136/hrt.2010.208132. Epub 2010 Oct 29.
• Cikirikcioglu M, Cherian S, Schussler O, Kalangos A. Regarding "The EVEREST II Trial: design and rationale for a randomized study of the Evalve MitraClip system compared with mitral valve surgery for mitral regurgitation". Am Heart J. 2011 Jul;162(1):e11-2; author reply e13. doi: 10.1016/j.ahj.2011.04.004. Epub 2011 Jun 12.
• Cohn LH. Percutaneous mitral valve repair with the edge-to-edge technique: a surgeon's perspective. J Am Coll Cardiol. 2005 Dec 6;46(11):2141-2. Epub 2005 Oct 17.
• Condado JA, Acquatella H, Rodriguez L, Whitlow P, Vélez-Gimo M, St Goar FG. Percutaneous edge-to-edge mitral valve repair: 2-year follow-up in the first human case. Catheter Cardiovasc Interv. 2006 Feb;67(2):323-5.
• Condado JA, Vélez-Gimón M. Catheter-based approach to mitral regurgitation. J Interv Cardiol. 2003 Dec;16(6):523-34. Review.
• Fann JI, St Goar FG, Komtebedde J, Oz MC, Block PC, Foster E, Butany J, Feldman T, Burdon TA. Beating heart catheter-based edge-to-edge mitral valve procedure in a porcine model: efficacy and healing response. Circulation. 2004 Aug 24;110(8):988-93. Epub 2004 Aug 9.
• Fann JI, St Goar FG. Percutaneous aortic valve replacement and mitral valve repair. Future Cardiol. 2005 May;1(3):393-403. doi: 10.1517/14796678.1.3.393.
• Feldman T, Glower D. Patient selection for percutaneous mitral valve repair: insight from early clinical trial applications. Nat Clin Pract Cardiovasc Med. 2008 Feb;5(2):84-90. doi: 10.1038/ncpcardio1068. Review.
• Feldman T, Kar S, Rinaldi M, Fail P, Hermiller J, Smalling R, Whitlow PL, Gray W, Low R, Herrmann HC, Lim S, Foster E, Glower D; EVEREST Investigators. Percutaneous mitral repair with the MitraClip system: safety and midterm durability in the initial EVEREST (Endovascular Valve Edge-to-Edge REpair Study) cohort. J Am Coll Cardiol. 2009 Aug 18;54(8):686-94. doi: 10.1016/j.jacc.2009.03.077.
• Herrmann HC, Kar S, Siegel R, Fail P, Loghin C, Lim S, Hahn R, Rogers JH, Bommer WJ, Wang A, Berke A, Lerakis S, Kramer P, Wong SC, Foster E, Glower D, Feldman T; EVEREST Investigators. Effect of percutaneous mitral repair with the MitraClip device on mitral valve area and gradient. EuroIntervention. 2009 Jan;4(4):437-42.
• Lim DS, Kunjummen BJ, Smalling R. Mitral valve repair with the MitraClip device after prior surgical mitral annuloplasty. Catheter Cardiovasc Interv. 2010 Sep 1;76(3):455-9. doi: 10.1002/ccd.22547.
• Luk A, Butany J, Ahn E, Fann JI, St Goar F, Thornton T, McDermott L, Madayag C, Komtebedde J. Mitral repair with the Evalve MitraClip device: histopathologic findings in the porcine model. Cardiovasc Pathol. 2009 Sep-Oct;18(5):279-85. doi: 10.1016/j.carpath.2008.07.001. Epub 2008 Aug 13.
• Pope NH, Lim S, Ailawadi G. Late calcific mitral stenosis after MitraClip procedure in a dialysis-dependent patient. Ann Thorac Surg. 2013 May;95(5):e113-4. doi: 10.1016/j.athoracsur.2012.10.067.
• Rogers JH, Yeo KK, Carroll JD, Cleveland J, Reece TB, Gillinov AM, Rodriguez L, Whitlow P, Woo YJ, Herrmann HC, Young JN. Late surgical mitral valve repair after percutaneous repair with the MitraClip system. J Card Surg. 2009 Nov-Dec;24(6):677-81. doi: 10.1111/j.1540-8191.2009.00901.x. Epub 2009 Jul 24.
• St Goar FG, Fann JI, Komtebedde J, Foster E, Oz MC, Fogarty TJ, Feldman T, Block PC. Endovascular edge-to-edge mitral valve repair: short-term results in a porcine model. Circulation. 2003 Oct 21;108(16):1990-3. Epub 2003 Oct 6.
• Tamburino C, Immè S, Barbanti M, Mulè M, Pistritto AM, Aruta P, Cammalleri V, Scarabelli M, Mangiafico S, Scandura S, Ussia GP. Reduction of mitral valve regurgitation with Mitraclip® percutaneous system. Minerva Cardioangiol. 2010 Oct;58(5):589-98.
• Tamburino C, Ussia GP, Maisano F, Capodanno D, La Canna G, Scandura S, Colombo A, Giacomini A, Michev I, Mangiafico S, Cammalleri V, Barbanti M, Alfieri O. Percutaneous mitral valve repair with the MitraClip system: acute results from a real world setting. Eur Heart J. 2010 Jun;31(11):1382-9. doi: 10.1093/eurheartj/ehq051. Epub 2010 Mar 18.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT00209274
• Other Study ID Numbers: Protocol #0401; Protocol #0401
• First Posted: Sep 21, 2005
• 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; CAD - Coronary Artery Disease; Heart Failure; Heart Attack; EVEREST; EVEREST I; EVEREST II; REALISM
• Additional relevant MeSH terms: Mitral Valve Insufficiency

Study Results

Participant Flow

Recruitment Details	The EVEREST II RCT was conducted in patients who were indicated for and could undergo mitral valve surgery. A total of 279 patients were enrolled at United States & Canada investigational sites between Aug 5,2005 to Sep 17,2008 time period. The subjects were randomized to Device group (n=184; MitraClip) &Control group (n=95;Mitral Valve Surgery).
Pre-assignment Detail	The EVEREST II RCT enrolled 279 patients (184 Device and 95 Control), of whom 21 patients (6 Device and 15 Control) did not undergo treatment per their randomized assignment, and are reported as "randomized not treated" (RNT). All RNT patients except one withdrew from the trial.

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Period Title: Overall Study
STARTED	184	95
COMPLETED	113	48
NOT COMPLETED	71	47

Baseline Characteristics

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)	Total
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.	Total of all reporting groups
Overall Participants	184	95	279
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.3 (12.8)	65.7 (12.9)	66.7 (12.8)
Age, Customized (Count of Participants)
18-75 years	129 70.1%	69 72.6%	198 71%
>75 years	55 29.9%	26 27.4%	81 29%
Sex: Female, Male (Count of Participants)
Female	69 37.5%	32 33.7%	101 36.2%
Male	115 62.5%	63 66.3%	178 63.8%
Region of Enrollment (Count of Participants)
United States	177 96.2%	93 97.9%	270 96.8%
Canada	7 3.8%	2 2.1%	9 3.2%
NYHA Functional Class (Count of Participants)
NYHA Functional Class I	17 9.2%	19 20%	36 12.9%
NYHA Functional Class II	73 39.7%	31 32.6%	104 37.3%
NYHA Functional Class III	82 44.6%	41 43.2%	123 44.1%
NYHA Functional Class IV	12 6.5%	4 4.2%	16 5.7%
Mitral regurgitation (MR) (Count of Participants)
0: None	0 0%	0 0%	0 0%
1+: Mild	0 0%	0 0%	0 0%
2+: Moderate	8 4.3%	7 7.4%	15 5.4%
3+: Moderate-to-Severe	130 70.7%	67 70.5%	197 70.6%
4+: Severe	46 25%	21 22.1%	67 24%
Left Ventricular (LV) Measurement (mL) [Mean (Standard Deviation) ]
LV End Diastolic Volume (LVEDV)	156.5 (39.0)	159.6 (46.3)	158.05 (42.65)
LV End Systolic Volume (LVESV)	63.5 (25.5)	63.8 (28.9)	63.65 (27.20)
Left Ventricular (LV) Measurement (cm) [Mean (Standard Deviation) ]
LV internal dimension diastole (LVIDd)	5.5 (0.7)	5.5 (0.7)	5.5 (0.7)
LV internal dimension systole (LVIDs)	3.7 (0.9)	3.5 (0.8)	3.6 (0.85)
36-Item Short Form Health Survey (SF-36) Quality of Life (QOL) (scores on a scale) [Mean (Standard Deviation) ]
Physical Component Score	41.1 (10.0)	41.9 (11.1)	41.4 (10.3)
Mental Component Score	47.1 (11.9)	46.6 (12.5)	46.9 (12.0)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Major Adverse Events (MAE)
Description	Defined as a 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, gastrointestinal (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

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

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	136	79
Count of Participants [Participants]	13 7.1%	45 47.4%

2. Primary Outcome

Title	Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	134	74
Count of Participants [Participants]	97 52.7%	65 68.4%

3. Secondary Outcome

Title	Freedom From All-Cause Mortality
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	158	70
Number [Percentage of participants]	93.7 50.9%	92.3 97.2%

4. Secondary Outcome

Title	Freedom From All-Cause Mortality
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	143	65
Number [Percentage of participants]	90.0 48.9%	89.6 94.3%

5. Secondary Outcome

Title	Freedom From All-Cause Mortality
Time Frame	3 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	133	57
Number [Percentage of participants]	87.5 47.6%	85.3 89.8%

6. Secondary Outcome

Title	Freedom From All-Cause Mortality
Time Frame	4 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	119	52
Number [Percentage of participants]	83.4 45.3%	82.3 86.6%

7. Secondary Outcome

Title	Freedom From All-Cause Mortality
Time Frame	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	58	24
Number [Percentage of participants]	81.2 44.1%	79 83.2%

8. Secondary Outcome

Title	Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	175	89
Count of Participants [Participants]	118 64.1%	65 68.4%

9. Secondary Outcome

Title	Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	126	68
Count of Participants [Participants]	87 47.3%	55 57.9%

10. Secondary Outcome

Title	Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR) in Intention to Treat Strategy Cohort
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	161	83
Number [participants]	100 54.3%	56 58.9%

11. Secondary Outcome

Title	Left Ventricular Ejection Fraction (LVEF)
Description	LVEF as determined by the core echo laboratory at 30 days or hospital discharge, whichever is longer.
Time Frame	At discharge (≤ 14 days following index procedure) 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	170	77
Mean (Standard Deviation) [Percentage of volume ejected]	56.9 (10.0)	53.9 (10.9)

12. Secondary Outcome

Title	Left Ventricular Ejection Fraction (LVEF)
Description	LVEF as determined by the core echo 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	144	65
Mean (Standard Deviation) [Percentage of volume ejected]	58.0 (8.7)	55.3 (10.2)

13. Secondary Outcome

Title	Left Ventricular Ejection Fraction (LVEF)
Description	LVEF as determined by the core echo 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	125	56
Mean (Standard Deviation) [Percentage of volume ejected]	56.9 (8.3)	55.8 (8.1)

14. Secondary Outcome

Title	Left Ventricular Ejection Fraction (LVEF)
Description	LVEF as determined by the core echo laboratory.
Time Frame	3 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	119	47
Mean (Standard Deviation) [Percentage of volume ejected]	57.0 (9.1)	58.4 (9.2)

15. Secondary Outcome

Title	Left Ventricular Ejection Fraction (LVEF)
Description	LVEF as determined by the core echo laboratory.
Time Frame	4 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	102	45
Mean (Standard Deviation) [Percentage of volume ejected]	57.6 (9.9)	58.9 (10.2)

16. Secondary Outcome

Title	Left Ventricular Ejection Fraction (LVEF)
Description	LVEF as determined by the core echo laboratory.
Time Frame	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	105	40
Mean (Standard Deviation) [Percentage of volume ejected]	56.5 (10.1)	57 (9.3)

17. Secondary Outcome

Title	Left Ventricular Status- Left Ventricular End-diastolic Volume (LVEDV), Left Ventricular End-systolic Volume (LVESV)
Description	Left Ventricular Status includes Left ventricular (LV) end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 30 days or hospital discharge, whichever is longer.
Time Frame	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	170	77
LVEDV	144.7 (40.0)	130.8 (40.5)
LVESV	63.7 (27.2)	62.0 (29.2)

18. Secondary Outcome

Title	Left Ventricular Status- LVEDV, LVESV
Description	Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV),as determined by the core echo laboratory at 12 months.
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	144	65
LVEDV	133.7 (35.5)	120.9 (44.3)
LVESV	57.5 (24.0)	56.2 (31.4)

19. Secondary Outcome

Title	Left Ventricular Status- LVEDV, LVESV
Description	Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 24 months.
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	125	56
LVEDV	123.4 (35.0)	110.5 (40.9)
LVESV	54.7 (24.7)	50.4 (26.3)

20. Secondary Outcome

Title	Left Ventricular Status- LVEDV, LVESV
Description	Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 3 years.
Time Frame	3 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	119	47
LVEDV	130.6 (32.6)	112.7 (40.2)
LVESV	57.7 (24.7)	48.0 (24.7)

21. Secondary Outcome

Title	Left Ventricular Status- LVEDV, LVESV
Description	Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 4 years
Time Frame	4 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	102	45
LVEDV	126.6 (33.1)	112.7 (40.4)
LVESV	55.0 (24.4)	48.1 (26.9)

22. Secondary Outcome

Title	Left Ventricular Status- LVEDV, LVESV
Description	Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 5 years.
Time Frame	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	105	40
LVEDV	126.3 (32.5)	112.9 (37.8)
LVESV	56.1 (23)	50.1 (26.3)

23. Secondary Outcome

Title	Left Ventricular Internal Dimension Systole (LVIDs)
Description	Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Time Frame	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	169	77
Mean (Standard Deviation) [cm]	3.6 (0.9)	3.5 (0.8)

24. Secondary Outcome

Title	Left Ventricular Internal Dimension Systole (LVIDs)
Description	Left Ventricular internal dimension systole (LVIDs) as determined by the core echo 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	146	66
Mean (Standard Deviation) [cm]	3.5 (0.8)	3.3 (0.8)

25. Secondary Outcome

Title	Left Ventricular Internal Dimension Systole (LVIDs)
Description	Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Time Frame	2 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	125	58
Mean (Standard Deviation) [cm]	3.4 (0.8)	3.2 (0.9)

26. Secondary Outcome

Title	Left Ventricular Internal Dimension Systole (LVIDs)
Description	Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Time Frame	3 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	120	50
Mean (Standard Deviation) [cm]	3.6 (0.9)	3.2 (0.8)

27. Secondary Outcome

Title	Left Ventricular Internal Dimension Systole (LVIDs)
Description	Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Time Frame	4 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	102	46
Mean (Standard Deviation) [cm]	3.6 (0.9)	3.3 (0.8)

28. Secondary Outcome

Title	Left Ventricular Internal Dimension Systole (LVIDs)
Description	Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Time Frame	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	104	42
Mean (Standard Deviation) [cm]	3.6 (0.9)	3.3 (0.9)

29. Secondary Outcome

Title	Left Ventricular Internal Dimension Diastole (LVIDd)
Description	Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory.
Time Frame	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	171	77
Mean (Standard Deviation) [cm]	5.3 (0.7)	5.0 (0.7)

30. Secondary Outcome

Title	Left Ventricular Internal Dimension Diastole (LVIDd)
Description	Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 12 months.
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	148	66
Mean (Standard Deviation) [cm]	5.1 (0.7)	4.8 (0.7)

31. Secondary Outcome

Title	Left Ventricular Internal Dimension Diastole (LVIDd)
Description	Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 24 months.
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	127	58
Mean (Standard Deviation) [cm]	5.0 (0.7)	4.7 (0.8)

32. Secondary Outcome

Title	Left Ventricular Internal Dimension Diastole (LVIDd)
Description	Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 3 years.
Time Frame	3 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	122	50
Mean (Standard Deviation) [cm]	5.2 (0.7)	4.8 (0.7)

33. Secondary Outcome

Title	Left Ventricular Internal Dimension Diastole (LVIDd)
Description	Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 4 years.
Time Frame	4 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	102	46
Mean (Standard Deviation) [cm]	5.3 (0.6)	4.8 (0.7)

34. Secondary Outcome

Title	Left Ventricular Internal Dimension Diastole (LVIDd)
Description	Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 5 years.
Time Frame	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	106	42
Mean (Standard Deviation) [cm]	5.2 (0.6)	4.9 (0.7)

35. Secondary Outcome

Title	Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
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	Baseline

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	184	95
NYHA Functional Class I	17 9.2%	19 20%
NYHA Functional Class II	73 39.7%	31 32.6%
NYHA Functional Class III	82 44.6%	41 43.2%
NYHA Functional Class IV	12 6.5%	4 4.2%

36. Secondary Outcome

Title	Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
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	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	168	75
NYHA Functional Class I	84 45.7%	40 42.1%
NYHA Functional Class II	67 36.4%	28 29.5%
NYHA Functional Class III	17 9.2%	7 7.4%
NYHA Functional Class IV	0 0%	0 0%

37. Secondary Outcome

Title	Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
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

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

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	151	66
NYHA Functional Class I	104 56.5%	46 48.4%
NYHA Functional Class II	44 23.9%	12 12.6%
NYHA Functional Class III	3 1.6%	7 7.4%
NYHA Functional Class IV	0 0%	1 1.1%

38. Secondary Outcome

Title	Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
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

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

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	132	60
NYHA Functional Class I	89 48.4%	43 45.3%
NYHA Functional Class II	42 22.8%	11 11.6%
NYHA Functional Class III	1 0.5%	4 4.2%
NYHA Functional Class IV	0 0%	2 2.1%

39. Secondary Outcome

Title	Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
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	3 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	120	50
NYHA Functional Class I	84 45.7%	41 43.2%
NYHA Functional Class II	32 17.4%	8 8.4%
NYHA Functional Class III	4 2.2%	1 1.1%
NYHA Functional Class IV	0 0%	0 0%

40. Secondary Outcome

Title	Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
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	4 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	105	48
NYHA Functional Class I	70 38%	35 36.8%
NYHA Functional Class II	29 15.8%	10 10.5%
NYHA Functional Class III	6 3.3%	3 3.2%
NYHA Functional Class IV	0 0%	0 0%

41. Secondary Outcome

Title	Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
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	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	106	42
NYHA Functional Class I	70 38%	33 34.7%
NYHA Functional Class II	27 14.7%	8 8.4%
NYHA Functional Class III	9 4.9%	1 1.1%
NYHA Functional Class IV	0 0%	0 0%

42. Secondary Outcome

Title	New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
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	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	168	75
Number [Percentage of participants]	10.1 5.5%	9.3 9.8%

43. Secondary Outcome

Title	Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
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

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

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	151	66
Number [Percentage of participants]	2.0 1.1%	12.1 12.7%

44. Secondary Outcome

Title	Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
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	2 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	132	60
Number [Percentage of participants]	0.8 0.4%	10.0 10.5%

45. Secondary Outcome

Title	Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
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	3 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	120	50
Number [Percentage of participants]	3.3 1.8%	2.0 2.1%

46. Secondary Outcome

Title	Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
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	4 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	105	48
Number [Percentage of participants]	5.7 3.1%	6.3 6.6%

47. Secondary Outcome

Title	Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
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	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	106	42
Number [Percentage of participants]	8.5 4.6%	2.4 2.5%

48. Secondary Outcome

Title	Short Form (SF)-36 Quality of Life Questionnaire.
Description	The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score) & mental health status (Mental Component Score) in relation to 8 health concepts: physical functioning, role limitations due to physical or emotional health, bodily pain, general health perceptions, vitality, social functioning, & general mental health. Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health. The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The SF-36 questionnaire consists of 36 questions in relation to eight health concepts: Physical functioning, role limitations due to physical health, bodily pain,general health perceptions,vitality (energy/fatigue),social functioning,role limitations due to emotional health and general mental health (psychological distress/wellbeing).

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	159	68
Physical Component Summary	43.8 (9.8)	36.9 (9.9)
Mental Component Summary	50.8 (10.8)	46.7 (12.4)

49. Secondary Outcome

Title	Short Form (SF)-36 Quality of Life Questionnaire.
Description	The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score) & mental health status (Mental Component Score) in relation to 8 health concepts: physical functioning, role limitations due to physical or emotional health, bodily pain, general health perceptions, vitality, social functioning, & general mental health. Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health. The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively.
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	139	64
Physical Component Summary	46.8 (9.5)	46.5 (10.6)
Mental Component Summary	52.9 (8.0)	50.4 (10.9)

50. Secondary Outcome

Title	Cardiac Output
Description	Cardiac output as measured by core lab echocardiography.
Time Frame	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	162	71
Mean (Standard Deviation) [L/min]	4.2 (1.2)	4.8 (1.3)

51. Secondary Outcome

Title	Cardiac Output
Description	Cardiac output as measured by core lab echocardiography.
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	147	67
Mean (Standard Deviation) [L/min]	4.4 (1.3)	4.6 (1.4)

52. Secondary Outcome

Title	Cardiac Output
Description	Cardiac output as measured by core lab echocardiography.
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	121	57
Mean (Standard Deviation) [L/min]	4.0 (1.1)	4.1 (1.1)

53. Secondary Outcome

Title	Cardiac Index
Description	Defined as cardiac output divided by body surface area, as measured by core lab echocardiography.
Time Frame	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	158	71
Mean (Standard Deviation) [L/min/m^2]	2.2 (0.6)	2.5 (0.6)

54. Secondary Outcome

Title	Cardiac Index (CI)
Description	Defined as cardiac output divided by body surface area as measured by core lab echocardiography. CI is a normalization of cardiac output to take into account the effect of body size on cardiac output requirements.
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	145	65
Mean (Standard Deviation) [L/min/m^2]	2.3 (0.6)	2.4 (0.6)

55. Secondary Outcome

Title	Cardiac Index
Description	Defined as cardiac output divided by body surface area, as measured by core lab echocardiography.
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	121	56
Mean (Standard Deviation) [L/min/m^2]	2.1 (0.5)	2.1 (0.5)

56. Secondary Outcome

Title	Regurgitant Volume
Description	Regurgitant volume as determined by the core echo laboratory. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Time Frame	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	131	45
Mean (Standard Deviation) [mL]	22.7 (17.6)	13.1 (10.7)

57. Secondary Outcome

Title	Regurgitant Volume
Description	Regurgitant volume as determined by the core echo 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	115	34
Mean (Standard Deviation) [mL]	19.9 (14.4)	14.6 (10.5)

58. Secondary Outcome

Title	Regurgitant Volume
Description	Regurgitant volume as determined by the core echo 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	85	25
Mean (Standard Deviation) [mL]	19.4 (13.2)	15.7 (10.5)

59. 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

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

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	131	45
Mean (Standard Deviation) [percentage of LV stroke volume]	25.4 (15.3)	17.3 (13.1)

60. Secondary Outcome

Title	Regurgitant Fraction
Description	Regurgitant fraction 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

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

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	115	34
Mean (Standard Deviation) [Percentage of LV stroke volume]	22.8 (13.8)	19.2 (12.1)

61. Secondary Outcome

Title	Regurgitant Fraction
Description	Regurgitant fraction 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

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

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	85	25
Mean (Standard Deviation) [Percentage of LV stroke volume]	24.5 (13.3)	20.4 (10.9)

62. Secondary Outcome

Title	Number of Participants With Clip Implant Rate
Description	Defined as the rate of successful implantation of MitraClip(s).
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

The number of participants analyzed includes subjects who had available follow up data at that time frame. MitraClip was not implanted in control group, hence overall number of patients analyzed will remain 0.

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	178	0
Count of Participants [Participants]	158 85.9%

63. Secondary Outcome

Title	Number of Participants With Acute Procedural Success
Description	Defined as successful MitraClip implantation with resulting MR of 2+ or less.
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

ITT population. The number of participants analyzed in Device group includes subjects who had available follow up data at that time frame. Not applicable for Mitral valve surgery patients as device was not implanted.

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	184	0
Count of Participants [Participants]	137 74.5%

64. Secondary Outcome

Title	Number of Participants With Acute Surgical Success
Description	Defined as successful mitral valve repair or replacement surgery.
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed in control group includes subjects who had available follow up data at that time frame. Not applicable for Device group patients as device was not implanted. The population includes all patients who underwent the index surgical procedure and excludes 15 patients who were randomized, but not treated.

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	0	80
Count of Participants [Participants]	80 43.5%

65. Secondary Outcome

Title	Number of Participants With Successful Clip Implant and Acute Procedural Success
Description	Acute procedural success is defined as MR severity ≤ 2 at discharge or 1 grade MR reduction at discharge accompanied by 1 level NYHA reduction.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The number of participants analyzed in Device group includes subjects who had available follow up data at that time frame. Not applicable for Mitral valve surgery patients as device was not implanted.

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	178	0
Device Implant Rate	158 85.9%
Acute Procedural Success	137 74.5%

66. Secondary Outcome

Title	Number of Participants With Mitral Valve Repair Success.
Description	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

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

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	177	91
Count of Participants [Participants]	114 62%	57 60%

67. Secondary Outcome

Title	Number of Participants With Mitral Valve Repair Success.
Description	Defined as freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+ at 12 months.
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	167	84
Count of Participants [Participants]	103 56%	46 48.4%

68. Secondary Outcome

Title	Number of Participants With Procedural Freedom From In-hospital MAE.
Time Frame	Day 0

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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	178	80
Count of Participants [Participants]	168 91.3%	41 43.2%

69. Secondary Outcome

Title	Number of Participants With Procedural Freedom From In-hospital MAE
Time Frame	Day 30

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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	178	80
Count of Participants [Participants]	10 5.4%	39 41.1%

70. Secondary Outcome

Title	Number of Participants With MAE: Surgery After Device and First Time Surgery Control
Time Frame	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	37	80
Count of Participants [Participants]	14 7.6%	40 42.1%

71. Secondary Outcome

Title	Number of Participants With Major Vascular Complications
Description	Vascular Complications defined as the occurrence of any of the following resulting through 30 days or hospital discharge, whichever is longer: Hematoma at access site >6 cm; Retroperitoneal hematoma; Arteriovenous (AV) fistula; Symptomatic peripheral ischemia / nerve injury or the clinical signs or symptoms lasting >48 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

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

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	184	95
Count of Participants [Participants]	9 4.9%	0 0%

72. Secondary Outcome

Title	Number of Participants With Major Vascular Complications
Description	Vascular Complications defined as the occurrence of any of the following resulting through 30 days or hospital discharge, whichever is longer: Hematoma at access site >6 cm; Retroperitoneal hematoma; Arteriovenous (AV) fistula; Symptomatic peripheral ischemia / nerve injury or the clinical signs or symptoms lasting >48 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

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

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	184	95
Count of Participants [Participants]	11 6%	0 0%

73. Secondary Outcome

Title	Number of Participants With Major Bleeding Complications.
Description	Major Bleeding Complications defined as procedure related bleeding that requires a transfusion of ≥2 units of blood products and/or surgical intervention at 30 days or hospital discharge, whichever is longer.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	184	95
Count of Participants [Participants]	9 4.9%	38 40%

74. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	184	95
Count of Participants [Participants]	17 9.2%	39 41.1%

75. Secondary Outcome

Title	Number of Participants With Major Adverse Events (MAE)
Time Frame	12 months.

Outcome Measure Data

Analysis Population Description

Intent to treat (ITT) population.

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	184	95
Count of Participants [Participants]	39 21.2%	44 46.3%

76. Secondary Outcome

Title	Number of Participants With MAE in Patients Over 75 Years of Age.
Time Frame	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	55	26
Count of Participants [Participants]	9 4.9%	12 12.6%

77. Secondary Outcome

Title	Number of Participants With MAE in Patients Over 75 Years of Age.
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	55	26
Count of Participants [Participants]	14 7.6%	14 14.7%

78. Secondary Outcome

Title	Number of Participants With Dysrhythmia
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	184	95
Count of Participants [Participants]	9 4.9%	22 23.2%

79. Secondary Outcome

Title	Number of Participants With Dysrhythmia
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	184	95
Count of Participants [Participants]	22 12%	22 23.2%

80. Secondary Outcome

Title	Number of Participants With Endocarditis.
Description	Defined as a diagnosis of endocarditis based on the Duke criteria. Infection in the lining of the heart, of the valves, or of the muscles of the heart. Signs of endocarditis may include persistent positive blood cultures and/or valvular structural abnormality and vegetations as seen using echocardiography.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	184	95
Count of Participants [Participants]	1 0.5%	1 1.1%

81. Secondary Outcome

Title	Number of Participants With Endocarditis.
Description	Defined as a diagnosis of endocarditis based on the Duke criteria. Infection in the lining of the heart, of the valves, or of the muscles of the heart. Signs of endocarditis may include persistent positive blood cultures and/or valvular structural abnormality and vegetations as seen using echocardiography.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	184	95
Count of Participants [Participants]	2 1.1%	1 1.1%

82. Secondary Outcome

Title	Number of Participants With Thrombosis.
Description	Defined as evidence of the formation of an independently moving thrombus on any part of the MitraClip or any commercially available implant used during surgery by echocardiography or fluoroscopy.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	184	95
Count of Participants [Participants]	0 0%	0 0%

83. Secondary Outcome

Title	Number of Participants With Thrombosis.
Description	Defined as evidence of the formation of an independently moving thrombus on any part of the MitraClip or any commercially available implant used during surgery by echocardiography or fluoroscopy.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	184	95
Count of Participants [Participants]	0 0%	0 0%

84. 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 repeat measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms. Reported as major or minor as defined below: Major: Requires intervention with red blood cell transfusion or other hematocrit increasing measures in the absence of other obvious bleeding. Minor: Does not require intervention.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	184	95
Count of Participants [Participants]	0 0%	0 0%

85. 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 repeat measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms. Reported as major or minor as defined below: Major: Requires intervention with red blood cell transfusion or other hematocrit increasing measures in the absence of other obvious bleeding. Minor: Does not require intervention.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	184	95
Count of Participants [Participants]	0 0%	0 0%

86. Secondary Outcome

Title	Number of Participants With Clinically Significant Atrial Septal Defect (ASD).
Description	Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	184	95
Count of Participants [Participants]	2 1.1%	0 0%

87. Secondary Outcome

Title	Number of Participants With Clinically Significant Atrial Septal Defect (ASD)
Description	Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	184	95
Count of Participants [Participants]	4 2.2%	0 0%

88. Secondary Outcome

Title	Number of Participants With Mitral Valve Stenosis
Description	Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	184	95
Count of Participants [Participants]	0 0%	0 0%

89. Secondary Outcome

Title	Number of Participants With Mitral Valve Stenosis
Description	Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	184	95
Count of Participants [Participants]	0 0%	0 0%

90. Secondary Outcome

Title	Number of Participants With Mitral Valve Stenosis
Description	Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	178	80
Count of Participants [Participants]	0 0%	1 1.1%

91. Secondary Outcome

Title	Number of Participants With Mitral Valve Stenosis
Description	Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography. A "confirmed" case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area < 1.5 cm^2. A "conservative" case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.
Time Frame	3 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	178	80
Conservative cases	3 1.6%	0 0%
Confirmed cases	0 0%	0 0%

92. Secondary Outcome

Title	Number of Participants With Mitral Valve Stenosis
Description	Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography. A "confirmed" case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area < 1.5 cm^2. A "conservative" case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.
Time Frame	4 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	178	80
Conservative cases	3 1.6%	0 0%
Confirmed cases	0 0%	0 0%

93. Secondary Outcome

Title	Number of Participants With Mitral Valve Stenosis
Description	Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography. A "confirmed" case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area < 1.5 cm^2. A "conservative" case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.
Time Frame	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	178	80
Conservative cases	4 2.2%	2 2.1%
Confirmed cases	1 0.5%	0 0%

94. Secondary Outcome

Title	Mitral Valve Area by Planimetry
Description	Mitral valve area as measured by core lab echocardiography.
Time Frame	At Discharge (≤14 days of index procedure)

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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	140	59
Mean (Standard Deviation) [cm^2]	3.7 (1.4)	3.6 (0.9)

95. 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

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

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	121	53
Mean (Standard Deviation) [cm^2]	3.6 (1.1)	3.9 (1.2)

96. 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

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

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	100	47
Mean (Standard Deviation) [cm^2]	3.2 (1.0)	3.7 (1.1)

97. 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

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

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	90	35
Mean (Standard Deviation) [cm^2]	3.3 (0.9)	3.3 (0.8)

98. Secondary Outcome

Title	Mitral Valve Area by Planimetry
Description	Mitral valve area as measured by core lab echocardiography.
Time Frame	3 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	81	34
Mean (Standard Deviation) [cm^2]	3.3 (0.9)	3.6 (0.9)

99. Secondary Outcome

Title	Mitral Valve Area by Planimetry
Description	Mitral valve area as measured by core lab echocardiography.
Time Frame	4 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	82	31
Mean (Standard Deviation) [cm^2]	3.2 (0.9)	3.8 (0.8)

100. Secondary Outcome

Title	Mitral Valve Area by Planimetry
Description	Mitral valve area as measured by core lab echocardiography.
Time Frame	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	75	30
Mean (Standard Deviation) [cm^2]	3.2 (1.0)	3.7 (1.0)

101. Secondary Outcome

Title	Mitral Valve Area by Planimetry Index
Description	Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
Time Frame	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	118	53
Mean (Standard Deviation) [cm^2/m^2]	1.9 (0.6)	2.0 (0.5)

102. Secondary Outcome

Title	Mitral Valve Area by Planimetry Index
Description	Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	105	48
Mean (Standard Deviation) [cm^2/m^2]	1.7 (0.5)	1.9 (0.6)

103. Secondary Outcome

Title	Mitral Valve Area by Planimetry Index
Description	Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	92	36
Mean (Standard Deviation) [cm^2/m^2]	1.7 (0.4)	1.8 (0.6)

104. Secondary Outcome

Title	Mitral Valve Area by Pressure Half-time
Description	Mitral valve area as measured by core lab echocardiography.
Time Frame	At Discharge (≤14 days of index procedure)

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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	166	71
Mean (Standard Deviation) [cm^2]	3.0 (1.1)	3.3 (1.1)

105. 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

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

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	156	66
Mean (Standard Deviation) [cm^2]	2.8 (1.0)	3.5 (1.2)

106. 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

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

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	140	63
Mean (Standard Deviation) [cm^2]	2.9 (1.0)	3.1 (1.1)

107. 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

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

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	121	52
Mean (Standard Deviation) [cm^2]	2.7 (0.7)	2.8 (0.7)

108. Secondary Outcome

Title	Mitral Valve Area by Pressure Half-time
Description	Mitral valve area as measured by core lab echocardiography.
Time Frame	3 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	120	48
Mean (Standard Deviation) [cm^2]	2.7 (0.7)	2.8 (0.6)

109. Secondary Outcome

Title	Mitral Valve Area by Pressure Half-time
Description	Mitral valve area as measured by core lab echocardiography.
Time Frame	4 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	102	48
Mean (Standard Deviation) [cm^2]	2.9 (0.8)	3.0 (1.0)

110. Secondary Outcome

Title	Mitral Valve Area by Pressure Half-time
Description	Mitral valve area as measured by core lab echocardiography.
Time Frame	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	101	41
Mean (Standard Deviation) [cm^2]	2.7 (0.7)	2.8 (0.7)

111. Secondary Outcome

Title	Mitral Valve Area by Pressure Half-time Index
Description	Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
Time Frame	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	153	66
Mean (Standard Deviation) [cm^2/m^2]	1.5 (0.6)	1.9 (0.7)

112. Secondary Outcome

Title	Mitral Valve Area by Pressure Half-time Index
Description	Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	142	65
Mean (Standard Deviation) [cm^2/m^2]	1.5 (0.6)	1.7 (0.7)

113. Secondary Outcome

Title	Mitral Valve Area by Pressure Half-time Index
Description	Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	123	54
Mean (Standard Deviation) [cm^2/m^2]	1.4 (0.4)	1.5 (0.5)

114. Secondary Outcome

Title	Transvalvular Mitral Valve Gradient
Description	Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
Time Frame	At Discharge (≤ 14 days following index procedure)

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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	168	73
Mean (Standard Deviation) [mmHg]	3.3 (1.9)	3.1 (1.6)

115. Secondary Outcome

Title	Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Description	Defined as the mean pressure gradient across the mitral valve as measured by Echocardiography Core Laboratory (ECL).
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	140	64
Mean (Standard Deviation) [mmHg]	3.2 (1.7)	3.1 (1.2)

116. Secondary Outcome

Title	Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Description	Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	121	53
Mean (Standard Deviation) [mmHg]	2.8 (1.4)	2.9 (1.8)

117. Secondary Outcome

Title	Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Description	Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
Time Frame	3 year

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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	120	48
Mean (Standard Deviation) [mmHg]	3.0 (1.5)	2.8 (1.4)

118. Secondary Outcome

Title	Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Description	Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
Time Frame	4 year

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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	102	48
Mean (Standard Deviation) [mmHg]	3.0 (1.4)	3.1 (1.5)

119. Secondary Outcome

Title	Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Description	Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
Time Frame	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	104	41
Mean (Standard Deviation) [mmHg]	3.0 (1.4)	3.0 (1.4)

120. Secondary Outcome

Title	Post-procedure Length of Hospital Stay
Time Frame	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	178	80
Mean (Standard Deviation) [days]	2.6 (6.3)	7.5 (4)

121. Secondary Outcome

Title	Post-procedure Intensive Care Unit (ICU) / Critical Care Unit (CCU) Duration
Time Frame	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	176	77
Mean (Standard Deviation) [hours]	38.6 (135.9)	82.3 (84.9)

122. Secondary Outcome

Title	Number of Participants With Hospital Re-admissions
Description	Defined as re-admission to the hospital for any reason. The endpoint was intended to capture each time a patient was re-admitted to the hospital for any reason and was to be reported as a rate through 30 days for both the Device and Control groups.
Time Frame	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	171	76
Count of Participants [Participants]	24 13%	14 14.7%

123. Secondary Outcome

Title	Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility/Hospital
Time Frame	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	178	80
Count of Participants [Participants]	6 3.3%	12 12.6%

124. Secondary Outcome

Title	Number of Participants With Incidence of Hospital Readmissions for Congestive Heart Failure (CHF).
Time Frame	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	171	76
Count of Participants [Participants]	2 1.1%	2 2.1%

125. Secondary Outcome

Title	Number of Participants With New Coumadin (Warfarin) Usage
Time Frame	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	143	65
Count of Participants [Participants]	13 7.1%	29 30.5%

126. Secondary Outcome

Title	Number of Participants With New Coumadin (Warfarin) Usage
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	143	65
Count of Participants [Participants]	36 19.6%	33 34.7%

127. Secondary Outcome

Title	Number of Participants With Durability of the MitraClip Device and Surgery.
Description	Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval. Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	137	80
Deaths	6 3.3%	5 5.3%
Surgeries	9 4.9%	2 2.1%
Patients with MR > 2+	22 12%	2 2.1%
Withdrawn/ Censored	3 1.6%	6 6.3%

128. Secondary Outcome

Title	Number of Participants With Durability of the MitraClip Device and Surgery.
Description	Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval. Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Time Frame	12-18 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	97	65
Deaths	0 0%	0 0%
Surgeries	0 0%	1 1.1%
Patients with MR > 2+	4 2.2%	2 2.1%
Withdrawn/ Censored	29 15.8%	25 26.3%

129. Secondary Outcome

Title	Number of Participants With Durability of the MitraClip Device and Surgery.
Description	Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval. Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Time Frame	18-24 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	64	37
Deaths	0 0%	0 0%
Surgeries	0 0%	0 0%
Patients with MR > 2+	3 1.6%	0 0%
Withdrawn/ Censored	19 10.3%	12 12.6%

130. Secondary Outcome

Title	Number of Participants With Durability of the MitraClip Device and Surgery.
Description	Device group: Freedom from death, surgery for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval. Control group: Freedom from death, re-operation for mitral valve dysfunction and MR > 2+ at the end of each follow-up interval.
Time Frame	24 months-3 year

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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	87	55
Deaths	0 0%	2 2.1%
Surgeries	0 0%	1 1.1%
Patients with MR > 2+	4 2.2%	0 0%
Withdrawn/ Censored	52 28.3%	32 33.7%

131. Secondary Outcome

Title	Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+
Description	Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	178	80
Count of Participants [Participants]	110 59.8%	71 74.7%

132. Secondary Outcome

Title	Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+
Description	Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	178	80
Count of Participants [Participants]	101 54.9%	66 69.5%

133. Secondary Outcome

Title	Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+
Description	Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR > 2+
Time Frame	3 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	178	80
Count of Participants [Participants]	96 52.2%	62 65.3%

134. Secondary Outcome

Title	Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Description	Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	178	80
Count of Participants [Participants]	141 76.6%	78 82.1%

135. Secondary Outcome

Title	Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Description	Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	178	80
Count of Participants [Participants]	140 76.1%	77 81.1%

136. Secondary Outcome

Title	Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Description	Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
Time Frame	3 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	178	80
Count of Participants [Participants]	139 75.5%	76 80%

137. Secondary Outcome

Title	Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Description	Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
Time Frame	4 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	178	80
Count of Participants [Participants]	137 74.5%	76 80%

138. Secondary Outcome

Title	Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Description	Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
Time Frame	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	178	80
Count of Participants [Participants]	135 73.4%	75 78.9%

139. Secondary Outcome

Title	Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Description	Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	178	80
Count of Participants [Participants]	133 72.3%	73 76.8%

140. Secondary Outcome

Title	Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Description	Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	178	80
Count of Participants [Participants]	127 69%	70 73.7%

141. Secondary Outcome

Title	Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Description	Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
Time Frame	3 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	178	80
Count of Participants [Participants]	122 66.3%	66 69.5%

142. Secondary Outcome

Title	Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Description	Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
Time Frame	4 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	178	80
Count of Participants [Participants]	116 63%	64 67.4%

143. Secondary Outcome

Title	Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Description	Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
Time Frame	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	178	80
Count of Participants [Participants]	111 60.3%	61 64.2%

144. Secondary Outcome

Title	Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment
Description	Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

The number of participants analyzed in device group includes subjects who had available follow up data at that time frame. Not applicable for Mitral valve surgery patients as device was not implanted.

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	158	0
Device Embolization	0 0%
Single Leaflet Device Attachment	10 5.4%

145. Secondary Outcome

Title	Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment
Description	Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device
Time Frame	12 months to 3 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed in device group includes subjects who had available follow up data at that time frame. Not applicable for Mitral valve surgery patients as device was not implanted.

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	158	0
Device Embolization	0 0%
Single Leaflet Device Attachment	0 0%

146. Secondary Outcome

Title	Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment
Description	Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device
Time Frame	12 months to 4 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed in device group includes subjects who had available follow up data at that time frame. Not applicable for Mitral valve surgery patients as device was not implanted.

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	158	0
Device Embolization	0 0%
Single Leaflet Device Attachment	0 0%

147. Secondary Outcome

Title	Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment
Description	Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device
Time Frame	12 months to 5 years

Outcome Measure Data

Analysis Population Description

The number of participants analyzed in device group includes subjects who had available follow up data at that time frame. Not applicable for Mitral valve surgery patients as device was not implanted.

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	158	0
Device Embolization	0 0%
Single Leaflet Device Attachment	0 0%

148. Secondary Outcome

Title	Number of Participants With Non-cerebral Thromboembolism.
Description	Defined as any thrombus or thromboembolism in the vasculature (excluding central nervous system events) or on the investigational device or any commercially available implant used during surgery confirmed by standard clinical and laboratory testing and which requires treatment.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	184	95
Count of Participants [Participants]	3 1.6%	3 3.2%

149. Secondary Outcome

Title	Number of Participants With MR Severity
Description	MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe. "Discharge" refers to each individual patient's date of hospital discharge. The discharge date varies for each patient, but in general, discharge occurs before 30-days follow-up. A 30-day echocardiogram will be used if the discharge echocardiogram is unavailable or otherwise uninterpretable.
Time Frame	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	173	76
0: None	2 1.1%	16 16.8%
1+:Mild	89 48.4%	48 50.5%
2+: Moderate	54 29.3%	12 12.6%
3+: Moderate-to-Severe	19 10.3%	0 0%
4+: Severe	9 4.9%	0 0%

150. Secondary Outcome

Title	Number of Participants With MR Severity
Description	MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	149	66
0: None	9 4.9%	13 13.7%
1+:Mild	55 29.9%	38 40%
2+: Moderate	57 31%	14 14.7%
3+: Moderate-to-Severe	21 11.4%	1 1.1%
4+: Severe	7 3.8%	0 0%

151. Secondary Outcome

Title	Number of Participants With MR Severity
Description	MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	127	57
0: None	2 1.1%	3 3.2%
1+: Mild	44 23.9%	45 47.4%
2+: Moderate	62 33.7%	7 7.4%
3+: Moderate-to-Severe	15 8.2%	1 1.1%
4+: Severe	4 2.2%	1 1.1%

152. Secondary Outcome

Title	Number of Participants With MR Severity
Description	MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
Time Frame	3 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	122	50
0: None	3 1.6%	7 7.4%
1+:Mild	45 24.5%	36 37.9%
2+: Moderate	55 29.9%	5 5.3%
3+: Moderate-to-Severe	19 10.3%	2 2.1%
4+: Severe	0 0%	0 0%

153. Secondary Outcome

Title	Number of Participants With MR Severity
Description	MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
Time Frame	4 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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	105	49
0: None	4 2.2%	4 4.2%
1+:Mild	41 22.3%	38 40%
2+: Moderate	40 21.7%	4 4.2%
3+: Moderate-to-Severe	20 10.9%	3 3.2%
4+: Severe	0 0%	0 0%

154. Secondary Outcome

Title	Number of Participants With MR Severity
Description	MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
Time Frame	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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	106	41
0: None	4 2.2%	6 6.3%
1+:Mild	49 26.6%	32 33.7%
2+: Moderate	34 18.5%	2 2.1%
3+: Moderate-to-Severe	18 9.8%	1 1.1%
4+: Severe	1 0.5%	0 0%

155. Secondary Outcome

Title	Number of Participants With Non-cerebral Thromboembolism.
Description	Defined as any thrombus or thromboembolism in the vasculature (excluding central nervous system events) or on the investigational device or any commercially available implant used during surgery confirmed by standard clinical and laboratory testing and which requires treatment.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	184	95
Count of Participants [Participants]	1 0.5%	2 2.1%

156. Secondary Outcome

Title	Number of Participants With Incidence of Mitral Valve Replacement
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	158	80
Count of Participants [Participants]	17 9.2%	11 11.6%

157. Secondary Outcome

Title	Number of Participants With Incidence of Mitral Valve Replacement
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	Device Group (MitraClip Device)	Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.	Mitral valve repair or replacement surgery.
Measure Participants	167	84
Count of Participants [Participants]	17 9.2%	14 14.7%

Adverse Events

Time Frame	5 years
Adverse Event Reporting Description	The EVEREST II RCT enrolled 279 patients (184 Device and 95 Control), of whom 21 patients (6 Device and 15 Control) did not undergo treatment per their randomized assignment, and are reported as "randomized not treated" (RNT). Therefore, the Adverse Event was evaluated in 178 patients in Device group and 80 patients in Control group.
Arm/Group Title	Device Group (MitraClip Device)		Control Group (Mitral Valve Surgery)
Arm/Group Description	Percutaneous mitral valve repair using MitraClip implant.		Mitral valve repair or replacement surgery.
All Cause Mortality
	Device Group (MitraClip Device)		Control Group (Mitral Valve Surgery)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/178 (11.2%)		9/80 (11.3%)
Serious Adverse Events
	Device Group (MitraClip Device)		Control Group (Mitral Valve Surgery)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	127/178 (71.3%)		54/80 (67.5%)
Blood and lymphatic system disorders
Anemia	16/178 (9%)	20	4/80 (5%)	4
Coagulopathy	1/178 (0.6%)	1	1/80 (1.3%)	1
Infection/bacteremia/septicemia	9/178 (5.1%)	10	2/80 (2.5%)	3
Hematologic:Other	2/178 (1.1%)	2	1/80 (1.3%)	1
Thrombocytopenia	2/178 (1.1%)	3	1/80 (1.3%)	1
Hemolysis	0/178 (0%)	0	1/80 (1.3%)	1
Cardiac disorders
Mitral Valve (MV) surgery	1/178 (0.6%)	1	0/80 (0%)	0
cardiac-single leaflet device attachment (SLDA)	8/178 (4.5%)	9	0/80 (0%)	0
Tamponade	3/178 (1.7%)	3	0/80 (0%)	0
Atrial arrhythmia	30/178 (16.9%)	37	9/80 (11.3%)	12
Atrial septal defect	3/178 (1.7%)	3	0/80 (0%)	0
Bradyarrhythmia	2/178 (1.1%)	2	3/80 (3.8%)	3
Cardiac arrest	6/178 (3.4%)	6	0/80 (0%)	0
Cardiomyopathy	3/178 (1.7%)	3	1/80 (1.3%)	1
Chest pain/angina	9/178 (5.1%)	10	2/80 (2.5%)	2
Congestive heart failure	19/178 (10.7%)	31	10/80 (12.5%)	23
Coronary artery disease	1/178 (0.6%)	1	0/80 (0%)	0
Endocarditis	3/178 (1.7%)	3	0/80 (0%)	0
Heart block	3/178 (1.7%)	3	2/80 (2.5%)	2
Lead displacement	2/178 (1.1%)	2	0/80 (0%)	0
Left ventricular dysfunction	1/178 (0.6%)	1	0/80 (0%)	0
Mitral valve injury	1/178 (0.6%)	1	0/80 (0%)	0
Myocardial infarction	3/178 (1.7%)	4	0/80 (0%)	0
Cardiac:Other	3/178 (1.7%)	3	7/80 (8.8%)	7
Cardiac:Other rhythm disorder	7/178 (3.9%)	8	6/80 (7.5%)	6
Pericardial effusion	7/178 (3.9%)	7	4/80 (5%)	4
Peripheral edema	1/178 (0.6%)	1	0/80 (0%)	0
Residual/recurrent mitral regurgitation (MR)	21/178 (11.8%)	21	3/80 (3.8%)	3
Supraventricular arrhythmia	2/178 (1.1%)	2	0/80 (0%)	0
Syncope/dizziness	4/178 (2.2%)	6	1/80 (1.3%)	1
Thrombus	2/178 (1.1%)	3	0/80 (0%)	0
Ventricular arrhythmia	7/178 (3.9%)	7	3/80 (3.8%)	3
Cardiogenic shock	0/178 (0%)	0	1/80 (1.3%)	1
Gastrointestinal disorders
Abdominal pain	4/178 (2.2%)	5	1/80 (1.3%)	3
Gastro intestinal related:Bleed	10/178 (5.6%)	13	1/80 (1.3%)	1
Gastro intestinal related:Infection	3/178 (1.7%)	3	2/80 (2.5%)	2
Gastro intestinal related:Other	20/178 (11.2%)	24	4/80 (5%)	5
Dysphagia	1/178 (0.6%)	1	0/80 (0%)	0
General disorders
Death	20/178 (11.2%)	20	9/80 (11.3%)	9
Generalized weakness/fatigue:other	3/178 (1.7%)	3	2/80 (2.5%)	2
Other	23/178 (12.9%)	29	7/80 (8.8%)	10
Fever	0/178 (0%)	0	2/80 (2.5%)	2
Incisional site pain	0/178 (0%)	0	1/80 (1.3%)	1
Infections and infestations
Infection:Other	4/178 (2.2%)	4	1/80 (1.3%)	1
Metabolism and nutrition disorders
Metabolic/endocrine disorders:Other	12/178 (6.7%)	12	6/80 (7.5%)	6
Musculoskeletal and connective tissue disorders
Connective tissue disorders	11/178 (6.2%)	11	5/80 (6.3%)	7
Nervous system disorders
Transient ischemic attack (TIA)	7/178 (3.9%)	7	3/80 (3.8%)	3
Intracerebral hemorrhage	3/178 (1.7%)	3	1/80 (1.3%)	1
Neurologic:Other	5/178 (2.8%)	5	2/80 (2.5%)	2
Neurologic:Stroke	5/178 (2.8%)	5	3/80 (3.8%)	9
Ischemic stroke	0/178 (0%)	0	1/80 (1.3%)	1
Psychiatric disorders
Mental disorders:Other	2/178 (1.1%)	2	0/80 (0%)	0
Renal and urinary disorders
Renal-Infection	3/178 (1.7%)	3	1/80 (1.3%)	1
Renal-Other	3/178 (1.7%)	4	3/80 (3.8%)	3
Renal insufficiency/failure	12/178 (6.7%)	13	3/80 (3.8%)	3
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease (COPD)	1/178 (0.6%)	1	1/80 (1.3%)	2
Bronchial/lung disorders	3/178 (1.7%)	3	2/80 (2.5%)	2
Respiratory:Other	8/178 (4.5%)	13	4/80 (5%)	4
Pleural effusion	6/178 (3.4%)	7	4/80 (5%)	6
Pneumonia	10/178 (5.6%)	11	7/80 (8.8%)	10
Pneumothorax	1/178 (0.6%)	1	1/80 (1.3%)	1
Pulmonary edema	3/178 (1.7%)	3	3/80 (3.8%)	3
Pulmonary embolism	3/178 (1.7%)	3	0/80 (0%)	0
Respiratory failure	13/178 (7.3%)	15	8/80 (10%)	8
Hemothorax	0/178 (0%)	0	1/80 (1.3%)	1
Skin and subcutaneous tissue disorders
Skin/mucosal/subcutaneous tissue disorders:other	1/178 (0.6%)	1	0/80 (0%)	0
Vascular disorders
Arteriovenous (AV) fistula	1/178 (0.6%)	1	0/80 (0%)	0
Deep vein thrombosis (DVT)	5/178 (2.8%)	6	0/80 (0%)	0
Peripheral Ischemia	1/178 (0.6%)	1	0/80 (0%)	0
Bleeding complication	16/178 (9%)	17	5/80 (6.3%)	6
Blood pressure complication	2/178 (1.1%)	2	0/80 (0%)	0
Bruise/contusion/ecchymosis	1/178 (0.6%)	1	0/80 (0%)	0
Hematoma	1/178 (0.6%)	1	1/80 (1.3%)	1
Hemodynamic instability	8/178 (4.5%)	8	2/80 (2.5%)	2
Vascular:Injury	1/178 (0.6%)	1	1/80 (1.3%)	1
Vascular:Other	3/178 (1.7%)	3	3/80 (3.8%)	3
Pseudoaneurysm	3/178 (1.7%)	4	0/80 (0%)	0
Thrombosis	2/178 (1.1%)	2	4/80 (5%)	4
Vascular:Shock	0/178 (0%)	0	1/80 (1.3%)	1
Other (Not Including Serious) Adverse Events
	Device Group (MitraClip Device)		Control Group (Mitral Valve Surgery)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	168/178 (94.4%)		80/80 (100%)
Blood and lymphatic system disorders
Anemia	32/178 (18%)	37	28/80 (35%)	32
Hemolysis	11/178 (6.2%)	15	12/80 (15%)	12
Thrombocytopenia	13/178 (7.3%)	13	7/80 (8.8%)	7
Hematologic:Other	0/178 (0%)	0	6/80 (7.5%)	6
Cardiac disorders
Atrial arrhythmia	23/178 (12.9%)	37	27/80 (33.8%)	33
Bradyarrhythmia	14/178 (7.9%)	16	6/80 (7.5%)	8
Chest pain/angina	33/178 (18.5%)	41	11/80 (13.8%)	14
Congestive heart failure	15/178 (8.4%)	22	11/80 (13.8%)	13
Myocardial ischemia	19/178 (10.7%)	21	6/80 (7.5%)	6
Cardiac:Other rhythm disorder	19/178 (10.7%)	21	11/80 (13.8%)	11
Palpitations	9/178 (5.1%)	9	5/80 (6.3%)	9
Peripheral edema	25/178 (14%)	28	23/80 (28.8%)	26
Residual/recurrent mitral regurgitation (MR)	29/178 (16.3%)	34	5/80 (6.3%)	5
Syncope/dizziness	38/178 (21.3%)	51	16/80 (20%)	18
Ventricular arrhythmia	9/178 (5.1%)	12	10/80 (12.5%)	12
Cardiomyopathy	0/178 (0%)	0	5/80 (6.3%)	5
Left ventricular dysfunction	0/178 (0%)	0	5/80 (6.3%)	5
Cardiac:Other	0/178 (0%)	0	12/80 (15%)	15
mitral stenosis	0/178 (0%)	0	4/80 (5%)	4
Gastrointestinal disorders
Gastrointestinal:Other	79/178 (44.4%)	119	48/80 (60%)	81
Gastrointestinal-Bleed	10/178 (5.6%)	13	0/80 (0%)	0
Abdominal pain	0/178 (0%)	0	4/80 (5%)	4
Dysphagia	0/178 (0%)	0	5/80 (6.3%)	5
General disorders
Fever	17/178 (9.6%)	19	13/80 (16.3%)	14
Generalized weakness/fatigue	32/178 (18%)	43	25/80 (31.3%)	30
Incisional site pain	49/178 (27.5%)	60	49/80 (61.3%)	53
Other	78/178 (43.8%)	133	35/80 (43.8%)	60
Metabolism and nutrition disorders
Metabolic/endocrine disorders:other	49/178 (27.5%)	73	38/80 (47.5%)	58
Musculoskeletal and connective tissue disorders
Connective tissue disorders:other	76/178 (42.7%)	114	26/80 (32.5%)	44
Nervous system disorders
Transient ischemic attack (TIA)	11/178 (6.2%)	12	9/80 (11.3%)	10
Neurologic:Other	16/178 (9%)	21	14/80 (17.5%)	17
Psychiatric disorders
Mental disorders:other	28/178 (15.7%)	35	25/80 (31.3%)	32
Renal and urinary disorders
Renal:Infection	10/178 (5.6%)	16	9/80 (11.3%)	12
Renal-Other	19/178 (10.7%)	22	6/80 (7.5%)	6
Renal insufficiency/failure	10/178 (5.6%)	15	9/80 (11.3%)	11
Respiratory, thoracic and mediastinal disorders
Bronchial/lung disorders	19/178 (10.7%)	21	22/80 (27.5%)	24
Respiratory:Infection	18/178 (10.1%)	22	10/80 (12.5%)	11
Respiratory:Other	79/178 (44.4%)	115	30/80 (37.5%)	45
Pleural effusion	19/178 (10.7%)	25	27/80 (33.8%)	31
Pulmonary edema	0/178 (0%)	0	6/80 (7.5%)	8
Respiratory failure	0/178 (0%)	0	5/80 (6.3%)	5
Pulmonary hypertension	0/178 (0%)	0	4/80 (5%)	4
Skin and subcutaneous tissue disorders
Skin/mucosal/subcutaneous tissue disorders:other	14/178 (7.9%)	19	5/80 (6.3%)	7
Vascular disorders
Bleeding complication	62/178 (34.8%)	73	17/80 (21.3%)	18
Blood pressure complication	19/178 (10.7%)	23	14/80 (17.5%)	18
Bruise/contusion/ecchymosis	26/178 (14.6%)	32	5/80 (6.3%)	5
Hematoma	26/178 (14.6%)	29	0/80 (0%)	0
Hemodynamic instability	45/178 (25.3%)	55	27/80 (33.8%)	31
Vascular:Other	9/178 (5.1%)	11	0/80 (0%)	0
Blood transfusion	0/178 (0%)	0	8/80 (10%)	8

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.