Trial Outcomes & Findings for EVEREST II Pivotal Study High Risk Registry (HRR) (NCT NCT01940120)

NCT ID: NCT01940120

Last Updated: 2018-11-07

Results Overview

Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint. Death is further divided into 2 categories: A. Cardiac death is defined as death due to any of the following: 1. Acute myocardial infarction. 2. Cardiac perforation/pericardial tamponade. 3. Arrhythmia or conduction abnormality. 4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure. 5. Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery. 6. Any death for which a cardiac cause cannot be excluded. B. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 78 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2018-11-07

Participant Flow

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

Participant milestones

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

Reasons for withdrawal

Measure	High Risk Registry Arm Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Study Death	40
Overall Study Withdrawal by Subject	8

Baseline Characteristics

EVEREST II Pivotal Study High Risk Registry (HRR)

Baseline characteristics by cohort

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Age, Continuous	76.7 years STANDARD_DEVIATION 9.8 • n=5 Participants
Age, Customized 18-75 years	30 participants n=5 Participants
Age, Customized >75 years	48 participants n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants
Region of Enrollment United States	77 participants n=5 Participants
Region of Enrollment Canada	1 participants n=5 Participants
Predicted Surgical Mortality	18.2 Probability percentage STANDARD_DEVIATION 8.0 • n=5 Participants
LV Measurement Left Ventricular End Diastolic Volume (LVEDV)	166.5 mL STANDARD_DEVIATION 50.7 • n=5 Participants
LV Measurement Left Ventricular End Systolic Volume (LVESV)	79.9 mL STANDARD_DEVIATION 42.7 • n=5 Participants
LV Measurement Left Ventricular Internal Diameter Diastole(LVIDd)	5.6 cm STANDARD_DEVIATION 0.7 • n=5 Participants
LV Measurement Left Ventricular Internal Diameter Systole (LVIDs)	3.9 cm STANDARD_DEVIATION 1.1 • n=5 Participants
36-Item Short Form Health Survey (SF-36) Quality of Life Physical Health (PCS)	31.6 scores on a scale STANDARD_DEVIATION 9.1 • n=5 Participants
36-Item Short Form Health Survey (SF-36) Quality of Life Mental Health (MCS)	44.2 scores on a scale STANDARD_DEVIATION 12.6 • n=5 Participants
NYHA Functional Class NYHA Functional Class I	0 participants n=5 Participants
NYHA Functional Class NYHA Functional Class II	8 participants n=5 Participants
NYHA Functional Class NYHA Functional Class III	47 participants n=5 Participants
NYHA Functional Class NYHA Functional Class IV	23 participants n=5 Participants
Number of patients hospitalized for CHF during 12 months before enrollment Number of patients hospitalized for CHF	33 participants n=5 Participants
Number of patients hospitalized for CHF during 12 months before enrollment Number of patients not hospitalized for CHF	45 participants n=5 Participants
Number of CHF events leading to hospitalizations during 12 months before enrollment	51 events n=5 Participants
Number of hospitalization days for CHF at 12 months before enrollment	6.0 days STANDARD_DEVIATION 4.6 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint. Death is further divided into 2 categories:

A. Cardiac death is defined as death due to any of the following:

1. Acute myocardial infarction.

2. Cardiac perforation/pericardial tamponade.

3. Arrhythmia or conduction abnormality.

4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure.

5. Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.

6. Any death for which a cardiac cause cannot be excluded.

B. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Composite Functional and Structural Measures - Freedom From Death	59 Participants

PRIMARY outcome

Timeframe: 12 months

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

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Percentage of Participants With Freedom From Death and Mitral Regurgitation (MR) >2+ Primary Analysis	56.4 percentage of participants
Percentage of Participants With Freedom From Death and Mitral Regurgitation (MR) >2+ Worst case Analysis	53.8 percentage of participants

PRIMARY outcome

Timeframe: 30 days

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

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

Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Outcome measures

Measure	High Risk Registry Arm n=71 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Clinical Measures of Benefit-New York Heart Association (NYHA) Class NYHA Functional Class I	14 Participants
Number of Participants With Clinical Measures of Benefit-New York Heart Association (NYHA) Class NYHA Functional Class II	38 Participants
Number of Participants With Clinical Measures of Benefit-New York Heart Association (NYHA) Class NYHA Functional Class III	16 Participants
Number of Participants With Clinical Measures of Benefit-New York Heart Association (NYHA) Class NYHA Functional Class IV	3 Participants

PRIMARY outcome

Timeframe: 12 months

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

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.

Outcome measures

Measure	High Risk Registry Arm n=54 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With New York Heart Association (NYHA) Class NYHA Functional Class I	18 Participants
Number of Participants With New York Heart Association (NYHA) Class NYHA Functional Class II	22 Participants
Number of Participants With New York Heart Association (NYHA) Class NYHA Functional Class III	13 Participants
Number of Participants With New York Heart Association (NYHA) Class NYHA Functional Class IV	1 Participants

PRIMARY outcome

Timeframe: 12 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=47 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Clinical Measures of Benefit-Quality of Life (QOL) as Measured by Short Form (SF) 36 PCS	36.1 score on a scale Standard Deviation 10.8
Clinical Measures of Benefit-Quality of Life (QOL) as Measured by Short Form (SF) 36 MCS	48.7 score on a scale Standard Deviation 11.9

PRIMARY outcome

Timeframe: 12 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=54 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Left Ventricular End Diastolic Volume (LVEDV)	139.7 ml Standard Deviation 42.6

PRIMARY outcome

Timeframe: 12 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=54 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Left Ventricular End Systolic Volume (LVESV)	72.2 ml Standard Deviation 35.8

PRIMARY outcome

Timeframe: 12 months

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

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

Outcome measures

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

PRIMARY outcome

Timeframe: 12 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=75 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Patients With CHF Having Hospitalization During Discharge Through 12 Months	12 Participants

PRIMARY outcome

Timeframe: 12 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=75 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of CHF Events Leading to Hospitalizations During Discharge Through 12 Months	22 Participants

PRIMARY outcome

Timeframe: Discharge or 30 days

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

Outcome measures

Measure	High Risk Registry Arm n=75 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Left Ventricular End Diastolic Volume (LVEDV)	147.9 ml Standard Deviation 48.8

PRIMARY outcome

Timeframe: Discharge or 30 days

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

Outcome measures

Measure	High Risk Registry Arm n=75 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Left Ventricular End Systolic Volume (LVESV)	74.3 ml Standard Deviation 40.4

PRIMARY outcome

Timeframe: Discharge or 30 days

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

Outcome measures

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

SECONDARY outcome

Timeframe: 30 days

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

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants Experiencing Major Adverse Events (MAE)	21 Participants

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants Experiencing Major Adverse Events	33 Participants

SECONDARY outcome

Timeframe: 30 Days

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

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Procedural Freedom From In-hospital MAE	61 participants

SECONDARY outcome

Timeframe: 30 days

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

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

Outcome measures

Measure	High Risk Registry Arm n=48 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants Over 75 Years of Age With MAE	14 Participants

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=48 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants Over 75 Years of Age With MAE	23 Participants

SECONDARY outcome

Timeframe: 30 days

Defined as the occurrence of any of the following resulting from the index procedure:

• Hematoma at access site >6 cm;
• Retroperitoneal hematoma;
• Arterial-venous fistula;
• Symptomatic peripheral ischemia/ nerve injury with clinical signs or symptoms lasting >24 hours;
• Vascular surgical repair at catheter access sites;
• Pulmonary embolism;
• Ipsilateral deep vein thrombus; or
• Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants Experiencing Major Vascular Complications	2 Participants

SECONDARY outcome

Timeframe: 12 months

Defined as the occurrence of any of the following resulting from the index procedure:

• Hematoma at access site >6 cm;
• Retroperitoneal hematoma;
• Arterial-venous fistula;
• Symptomatic peripheral ischemia/ nerve injury with clinical signs or symptoms lasting >24 hours;
• Vascular surgical repair at catheter access sites;
• Pulmonary embolism;
• Ipsilateral deep vein thrombus; or
• Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants Experiencing Major Vascular Complications	3 Participants

SECONDARY outcome

Timeframe: 30 days

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

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Major Bleeding Complications	13 Participants

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Major Bleeding Complications	15 Participants

SECONDARY outcome

Timeframe: 30 days

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

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Non-cerebral Thromboembolism	0 Participants

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Non-cerebral Thromboembolism	1 Participants

SECONDARY outcome

Timeframe: 30 days

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

Outcome measures

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

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

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

SECONDARY outcome

Timeframe: 30 days

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

Outcome measures

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

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

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

SECONDARY outcome

Timeframe: 30 days

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

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Dysrhythmias	5 Participants

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Dysrhythmias	8 Participants

SECONDARY outcome

Timeframe: 30 days

Using Duke Criteria, endocarditis can be confirmed by:

Pathological criteria: Endocarditis is confirmed if microorganisms are identified by culture or histology in a vegetation, embolized vegetation, or an intracardiac abscess; or if pathological lesions are observed & histologically confirmed showing active endocarditis.

Clinical criteria: Endocarditis is confirmed by the presence of 2 major criteria, 1 major plus 3 minor criteria, or 5 minor criteria. Major criteria include persistently +ve blood cultures with the presence of typical organisms for endocarditis; persistent bacteremia; evidence of endocardial involvement with positive echocardiogram with signs of oscillating vegetation, abscesses, valve perforation, new partial dehiscence of prosthetic valve or new valvular regurgitation. Minor criteria include predisposing heart condition, fever, vascular phenomena, immunologic phenomena, & positive blood culture or echocardiogram not meeting major criteria.

Outcome measures

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

SECONDARY outcome

Timeframe: 12 months

Using Duke Criteria, endocarditis can be confirmed by:

Pathological criteria: Endocarditis is confirmed if microorganisms are identified by culture or histology in a vegetation, embolized vegetation, or an intracardiac abscess; or if pathological lesions are observed & histologically confirmed showing active endocarditis.

Clinical criteria: Endocarditis is confirmed by the presence of 2 major criteria, 1 major plus 3 minor criteria, or 5 minor criteria.

Major criteria include persistently +ve blood cultures with the presence of typical organisms for endocarditis; persistent bacteremia; evidence of endocardial involvement with positive echocardiogram with signs of oscillating vegetation, abscesses, valve perforation, new partial dehiscence of prosthetic valve or new valvular regurgitation.

Minor criteria include predisposing heart condition, fever, vascular phenomena, immunologic phenomena, & positive blood culture or echocardiogram not meeting major criteria.

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Endocarditis	1 Participants

SECONDARY outcome

Timeframe: 30 days

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

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Atrial Septal Defect (ASD)	2 Participants

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Atrial Septal Defect (ASD)	2 Participants

SECONDARY outcome

Timeframe: 30 days

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

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

Outcome measures

Measure	High Risk Registry Arm n=72 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Mitral Valve Stenosis	0 Participants

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=72 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Mitral Valve Stenosis	0 Participants

SECONDARY outcome

Timeframe: 24 months

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

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Mitral Valve Stenosis	2 Participants

SECONDARY outcome

Timeframe: 36 months

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

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Mitral Valve Stenosis	2 Participants

SECONDARY outcome

Timeframe: 48 months

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

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Mitral Valve Stenosis	2 Participants

SECONDARY outcome

Timeframe: 30 days

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

Mitral valve area as measured by core lab echocardiography.

Outcome measures

Measure	High Risk Registry Arm n=50 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Area: By Planimetry	3.3 cm^2 Standard Deviation 0.9

SECONDARY outcome

Timeframe: 12 months

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

Mitral valve area as measured by core lab echocardiography.

Outcome measures

Measure	High Risk Registry Arm n=45 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Area: By Planimetry	3.0 cm^2 Standard Deviation 1.0

SECONDARY outcome

Timeframe: 24 months

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

Mitral valve area as measured by core lab echocardiography.

Outcome measures

Measure	High Risk Registry Arm n=19 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Area: By Planimetry	3.3 cm^2 Standard Deviation 0.6

SECONDARY outcome

Timeframe: 36 months

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

Mitral valve area as measured by core lab echocardiography.

Outcome measures

Measure	High Risk Registry Arm n=25 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Area: By Planimetry	2.9 cm^2 Standard Deviation 0.8

SECONDARY outcome

Timeframe: 48 months

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

Mitral valve area as measured by core lab echocardiography.

Outcome measures

Measure	High Risk Registry Arm n=18 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Area: By Planimetry	3.0 cm^2 Standard Deviation 0.7

SECONDARY outcome

Timeframe: 60 months

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

Mitral valve area as measured by core lab echocardiography.

Outcome measures

Measure	High Risk Registry Arm n=19 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Area: By Planimetry	2.9 cm^2 Standard Deviation 0.8

SECONDARY outcome

Timeframe: 30 days

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

Mitral valve area as measured by core lab echocardiography.

Outcome measures

Measure	High Risk Registry Arm n=66 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Area: By Pressure Half-time	2.9 cm^2 Standard Deviation 1.2

SECONDARY outcome

Timeframe: 12 months

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

Mitral valve area as measured by core lab echocardiography.

Outcome measures

Measure	High Risk Registry Arm n=53 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Area: By Pressure Half-time	3.0 cm^2 Standard Deviation 1.2

SECONDARY outcome

Timeframe: 24 months

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

Mitral valve area as measured by core lab echocardiography.

Outcome measures

Measure	High Risk Registry Arm n=40 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Area: By Pressure Half-time	2.8 cm^2 Standard Deviation 0.8

SECONDARY outcome

Timeframe: 36 months

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

Mitral valve area as measured by core lab echocardiography.

Outcome measures

Measure	High Risk Registry Arm n=35 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Area: By Pressure Half-time	2.9 cm^2 Standard Deviation 0.8

SECONDARY outcome

Timeframe: 48 months

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

Mitral valve area as measured by core lab echocardiography.

Outcome measures

Measure	High Risk Registry Arm n=31 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Area: By Pressure Half-time	2.8 cm^2 Standard Deviation 0.9

SECONDARY outcome

Timeframe: 60 months

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

Mitral valve area as measured by core lab echocardiography.

Outcome measures

Measure	High Risk Registry Arm n=24 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Area: By Pressure Half-time	2.8 cm^2 Standard Deviation 0.7

SECONDARY outcome

Timeframe: 30 days

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

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

Outcome measures

Measure	High Risk Registry Arm n=50 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Area Index : By Planimetry	1.7 cm^2/m^2 Standard Deviation 0.5

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=45 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Area Index : By Planimetry	1.6 cm^2/m^2 Standard Deviation 0.5

SECONDARY outcome

Timeframe: 24 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=19 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Area Index : By Planimetry	1.7 cm^2/m^2 Standard Deviation 0.3

SECONDARY outcome

Timeframe: 36 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=25 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Area Index : By Planimetry	1.5 cm^2/m^2 Standard Deviation 0.4

SECONDARY outcome

Timeframe: 48 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=18 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Area Index : By Planimetry	1.5 cm^2/m^2 Standard Deviation 0.4

SECONDARY outcome

Timeframe: 60 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=19 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Area Index : By Planimetry	1.5 cm^2/m^2 Standard Deviation 0.4

SECONDARY outcome

Timeframe: 30 days

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

Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to Body surface area (BSA).

[MVA Index = MVA (cm^2)/BSA (m^2)]

Outcome measures

Measure	High Risk Registry Arm n=65 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Area (MVA) Index: by Pressure-Half Time Formula	1.6 cm^2/m^2 Standard Deviation 0.7

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=53 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Area Index : By Pressure Half-time Formula	1.6 cm^2/m^2 Standard Deviation 0.7

SECONDARY outcome

Timeframe: 24 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=40 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Area Index : By Pressure Half-time Formula	1.5 cm^2/m^2 Standard Deviation 0.5

SECONDARY outcome

Timeframe: 36 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=35 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Area Index : By Pressure Half-time Formula	1.5 cm^2/m^2 Standard Deviation 0.5

SECONDARY outcome

Timeframe: 48 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=30 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Area Index : By Pressure Half-time Formula	1.5 cm^2/m^2 Standard Deviation 0.5

SECONDARY outcome

Timeframe: 60 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=24 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Area Index : By Pressure Half-time Formula	1.5 cm^2/m^2 Standard Deviation 0.4

SECONDARY outcome

Timeframe: 30 days

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

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

Outcome measures

Measure	High Risk Registry Arm n=69 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Transvalvular Mitral Valve Gradient	3.9 mmHg Standard Deviation 2.6

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=53 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Transvalvular Mitral Valve Gradient	3.6 mmHg Standard Deviation 2.9

SECONDARY outcome

Timeframe: 24 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=40 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Transvalvular Mitral Valve Gradient	3.2 mmHg Standard Deviation 1.9

SECONDARY outcome

Timeframe: 36 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=36 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Transvalvular Mitral Valve Gradient	3.8 mmHg Standard Deviation 2.7

SECONDARY outcome

Timeframe: 48 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=31 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Transvalvular Mitral Valve Gradient	3.6 mmHg Standard Deviation 1.8

SECONDARY outcome

Timeframe: 60 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=24 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Transvalvular Mitral Valve Gradient	3.8 mmHg Standard Deviation 2

SECONDARY outcome

Timeframe: 30 days

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: 30 days

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

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

Outcome measures

Measure	High Risk Registry Arm n=49 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With New Coumadin Use	9 Participants

SECONDARY outcome

Timeframe: 6 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=49 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With New Coumadin Use	11 Participants

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=49 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With New Coumadin Use	12 Participants

SECONDARY outcome

Timeframe: 30 Days

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

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants Discharged to a Nursing Home or Skilled Nursing Facility or Hospital	6 Participants

SECONDARY outcome

Timeframe: Length of Hospital Stay, assessed at 30 days

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

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Post-procedure Length of Hospital Stay	3.9 days Standard Deviation 6.4

SECONDARY outcome

Timeframe: Length of ICU/CCU stay, assessed at 30 Days

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

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Post-procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU) Time	52.3 hours Standard Deviation 80.6

SECONDARY outcome

Timeframe: 30 Days

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

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Successful Clip Implant	74 Participants

SECONDARY outcome

Timeframe: 30 days

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

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With High Risk Procedural Success	60 Participants

SECONDARY outcome

Timeframe: Discharge or 30 days

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: 24 months

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: 36 months

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: 48 months

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: 60 months

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=56 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Treatment Durability	39 Participants

SECONDARY outcome

Timeframe: 24 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=53 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Treatment Durability	30 Participants

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=62 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Clinical Durability	43 Participants

SECONDARY outcome

Timeframe: 24 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=59 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Clinical Durability	35 Participants

SECONDARY outcome

Timeframe: 24 months

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

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.

Outcome measures

Measure	High Risk Registry Arm n=43 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class NYHA Functional Class I	13 Participants
Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class NYHA Functional Class II	24 Participants
Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class NYHA Functional Class III	5 Participants
Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class NYHA Functional Class IV	1 Participants

SECONDARY outcome

Timeframe: 36 months

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

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.

Outcome measures

Measure	High Risk Registry Arm n=37 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class NYHA Functional Class I	10 Participants
Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class NYHA Functional Class II	20 Participants
Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class NYHA Functional Class III	7 Participants
Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class NYHA Functional Class IV	0 Participants

SECONDARY outcome

Timeframe: 48 months

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

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.

Outcome measures

Measure	High Risk Registry Arm n=31 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class NYHA Functional Class I	8 Participants
Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class NYHA Functional Class II	20 Participants
Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class NYHA Functional Class III	3 Participants
Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class NYHA Functional Class IV	0 Participants

SECONDARY outcome

Timeframe: 60 months

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

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.

Outcome measures

Measure	High Risk Registry Arm n=24 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With New York Heart Association (NYHA) Class NYHA Functional Class I	6 Participants
Number of Participants With New York Heart Association (NYHA) Class NYHA Functional Class II	14 Participants
Number of Participants With New York Heart Association (NYHA) Class NYHA Functional Class III	4 Participants
Number of Participants With New York Heart Association (NYHA) Class NYHA Functional Class IV	0 Participants

SECONDARY outcome

Timeframe: 24 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=39 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Left Ventricular End-diastolic Volume (LVEDV).	136.3 mL Standard Deviation 37.8

SECONDARY outcome

Timeframe: 36 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=36 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Left Ventricular End-diastolic Volume (LVEDV).	135.7 mL Standard Deviation 40.3

SECONDARY outcome

Timeframe: 48 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=29 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Left Ventricular End-diastolic Volume (LVEDV).	139.5 mL Standard Deviation 46.6

SECONDARY outcome

Timeframe: 60 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=24 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Left Ventricular End-diastolic Volume (LVEDV).	133.5 mL Standard Deviation 48.9

SECONDARY outcome

Timeframe: 24 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=39 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Left Ventricular End-systolic Volume (LVESV).	71.3 mL Standard Deviation 33.4

SECONDARY outcome

Timeframe: 36 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=36 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Left Ventricular End-systolic Volume (LVESV).	66.4 mL Standard Deviation 33.1

SECONDARY outcome

Timeframe: 48 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=28 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Left Ventricular End-systolic Volume (LVESV).	73.3 mL Standard Deviation 36.9

SECONDARY outcome

Timeframe: 60 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=24 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Left Ventricular End-systolic Volume (LVESV).	67.2 mL Standard Deviation 38

SECONDARY outcome

Timeframe: 24 months

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: 36 months

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: 48 months

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: 60 months

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=12 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Days Re-hospitalized for CHF	6.6 days Standard Deviation 3.7

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=75 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Hospital Re-Admissions for Congestive Heart Failure (CHF)	22 Events

SECONDARY outcome

Timeframe: 30 days

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: 24 months

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: 30 days

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: 24 months

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: 30 Days

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: 24 months

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: 30 Days

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: 24 months

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Discharge or 30 days

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: 24 months

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: 36 months

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: 48 months

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: 60 months

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

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

Outcome measures

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

SECONDARY outcome

Timeframe: Baseline

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

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Percentage of Participants With Freedom From Mitral Valve Surgery	100 percentage of participants

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=58 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Percentage of Participants With Freedom From Mitral Valve Surgery	100 percentage of participants

SECONDARY outcome

Timeframe: 24 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=45 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Percentage of Participants With Freedom From Mitral Valve Surgery	98.1 percentage of participants

SECONDARY outcome

Timeframe: 36 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=39 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Percentage of Participants With Freedom From Mitral Valve Surgery	98.1 percentage of participants

SECONDARY outcome

Timeframe: 48 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=35 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Percentage of Participants With Freedom From Mitral Valve Surgery	95.5 percentage of participants

SECONDARY outcome

Timeframe: 60 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=14 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Percentage of Participants With Freedom From Mitral Valve Surgery	95.5 percentage of participants

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Mitral Valve Repair Success	44 Participants

SECONDARY outcome

Timeframe: 24 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=75 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Mitral Valve Repair Success	37 Participants

SECONDARY outcome

Timeframe: 24 months

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

Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint. Death is further divided into 2 categories:

A. Cardiac death is defined as death due to any of the following:

1. Acute myocardial infarction.

2. Cardiac perforation/pericardial tamponade.

3. Arrhythmia or conduction abnormality.

4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure.

5. Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.

6. Any death for which a cardiac cause cannot be excluded.

B. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

Outcome measures

Measure	High Risk Registry Arm n=46 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Composite Functional and Structural Measures - Percentage of Participants With Freedom From Death	64.6 percentage of participants

SECONDARY outcome

Timeframe: 24 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Percentage of Participants With Composite Functional and Structural Measures - Freedom From Death and MR >2+ Primary Analysis	49.3 percentage of participants Interval 37.6 to 61.1
Percentage of Participants With Composite Functional and Structural Measures - Freedom From Death and MR >2+ Worstcase Analysis	46.2 percentage of participants Interval 34.8 to 57.8

SECONDARY outcome

Timeframe: 0 to 12 months

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

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

A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.

Outcome measures

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

SECONDARY outcome

Timeframe: 24 months

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

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

A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.

Outcome measures

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

SECONDARY outcome

Timeframe: 48 months

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

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

A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.

Outcome measures

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

SECONDARY outcome

Timeframe: 36 months

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

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

A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.

Outcome measures

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

SECONDARY outcome

Timeframe: 60 months

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

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

A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.

Outcome measures

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

SECONDARY outcome

Timeframe: 60 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=30 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Mitral Valve Surgery Post-MitraClip Procedure	2 Participants

SECONDARY outcome

Timeframe: 0 to 5 years

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

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

Outcome measures

Measure	High Risk Registry Arm n=30 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Second MitraClip Device Implanted	2 Participants

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=58 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery	75.6 percentage of participants

SECONDARY outcome

Timeframe: 24 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=45 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery	63.2 percentage of participants

SECONDARY outcome

Timeframe: 36 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=39 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery	57.4 percentage of participants

SECONDARY outcome

Timeframe: 48 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=35 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery	51.5 percentage of participants

SECONDARY outcome

Timeframe: 60 months

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

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

Outcome measures

Measure	High Risk Registry Arm n=14 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery	41.2 percentage of participants

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Mitral Valve Replacement	2 Participants

SECONDARY outcome

Timeframe: 24 months

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

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Mitral Valve Replacement	1 Participants

SECONDARY outcome

Timeframe: 36 months

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

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Mitral Valve Replacement	2 Participants

SECONDARY outcome

Timeframe: 48 months

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

Outcome measures

Measure	High Risk Registry Arm n=78 Participants Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Mitral Valve Replacement	2 Participants

Adverse Events

High Risk Registry Arm

Serious events: 69 serious events

Other events: 77 other events

Deaths: 25 deaths

Serious adverse events

Measure	High Risk Registry Arm n=78 participants at risk Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant. Percutaneous mitral valve repair using MitraClip implant: Procedure/Surgery: Mitral valve repair or replacement surgery Repair or replacement of mitral valve
Blood and lymphatic system disorders Anemia	11.5% 9/78 • 5 years
Blood and lymphatic system disorders Coagulopathy	2.6% 2/78 • 5 years
Blood and lymphatic system disorders Hematologic - Other	2.6% 2/78 • 5 years
Blood and lymphatic system disorders Infection/Bacteremia/Septicemia	7.7% 6/78 • 5 years
Blood and lymphatic system disorders Thrombocytopenia	1.3% 1/78 • 5 years
Cardiac disorders Atrial arrhythmia	11.5% 9/78 • 5 years
Cardiac disorders Atrial septal defect	1.3% 1/78 • 5 years
Cardiac disorders Bradyarrhythmia	2.6% 2/78 • 5 years
Cardiac disorders Cardiac arrest	3.8% 3/78 • 5 years
Cardiac disorders Cardiac disorders: Other	2.6% 2/78 • 5 years
Cardiac disorders Cardiogenic shock	1.3% 1/78 • 5 years
Cardiac disorders Cardiomyopathy	1.3% 1/78 • 5 years
Cardiac disorders Chest pain/Angina	11.5% 9/78 • 5 years
Cardiac disorders Congestive heart failure	26.9% 21/78 • 5 years
Cardiac disorders Coronary artery disease	2.6% 2/78 • 5 years
Cardiac disorders Endocarditis	2.6% 2/78 • 5 years
Cardiac disorders Heart block	3.8% 3/78 • 5 years
Cardiac disorders Lead displacement	2.6% 2/78 • 5 years
Cardiac disorders Myocardial infarction	9.0% 7/78 • 5 years
Cardiac disorders Myocardial ischemia	1.3% 1/78 • 5 years
Cardiac disorders Other rhythm disorder	9.0% 7/78 • 5 years
Cardiac disorders Palpitations	1.3% 1/78 • 5 years
Cardiac disorders Residual/Recurrent MR	1.3% 1/78 • 5 years
Cardiac disorders Supraventricular arrhythmia	1.3% 1/78 • 5 years
Cardiac disorders Syncope/Dizziness	2.6% 2/78 • 5 years
Cardiac disorders Tamponade	1.3% 1/78 • 5 years
Cardiac disorders Ventricular arrhythmia	3.8% 3/78 • 5 years
Gastrointestinal disorders Abdominal pain	5.1% 4/78 • 5 years
Gastrointestinal disorders Bleed	11.5% 9/78 • 5 years
Gastrointestinal disorders Gastrointestinal disorders: Other	11.5% 9/78 • 5 years
Gastrointestinal disorders Infection	1.3% 1/78 • 5 years
General disorders Death	32.1% 25/78 • 5 years
General disorders General disorders: Other	14.1% 11/78 • 5 years
General disorders Generalized weakness/Fatigue	2.6% 2/78 • 5 years
General disorders Infection	9.0% 7/78 • 5 years
General disorders Metabolic/Endocrine disorders	9.0% 7/78 • 5 years
Musculoskeletal and connective tissue disorders Connective tissue disorders	10.3% 8/78 • 5 years
Nervous system disorders Intracerebral hemorrhage	6.4% 5/78 • 5 years
Nervous system disorders Nervous system disorders: Other	7.7% 6/78 • 5 years
Nervous system disorders Neurologic - Stroke	1.3% 1/78 • 5 years
Nervous system disorders Transient ischemic attack (TIA)	7.7% 6/78 • 5 years
Renal and urinary disorders Renal Infection	11.5% 9/78 • 5 years
Renal and urinary disorders Renal and urinary disorders: Other	2.6% 2/78 • 5 years
Renal and urinary disorders Renal insufficiency/Failure	25.6% 20/78 • 5 years
Respiratory, thoracic and mediastinal disorders Bronchial/lung disorders	1.3% 1/78 • 5 years
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease (COPD)	2.6% 2/78 • 5 years
Respiratory, thoracic and mediastinal disorders Pleural effusion	9.0% 7/78 • 5 years
Respiratory, thoracic and mediastinal disorders Pneumonia	9.0% 7/78 • 5 years
Respiratory, thoracic and mediastinal disorders Pulmonary edema	6.4% 5/78 • 5 years
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	1.3% 1/78 • 5 years
Respiratory, thoracic and mediastinal disorders Respiratory - Other	14.1% 11/78 • 5 years
Respiratory, thoracic and mediastinal disorders Respiratory Infection	2.6% 2/78 • 5 years
Respiratory, thoracic and mediastinal disorders Respiratory failure	14.1% 11/78 • 5 years
Vascular disorders Arteriovenous (AV) fistula	2.6% 2/78 • 5 years
Vascular disorders Bleeding complication	6.4% 5/78 • 5 years
Vascular disorders Deep vein thrombosis (DVT)	1.3% 1/78 • 5 years
Vascular disorders Embolization	1.3% 1/78 • 5 years
Vascular disorders Hemodynamic instability	11.5% 9/78 • 5 years
Vascular disorders Pseudoaneurysm	2.6% 2/78 • 5 years
Vascular disorders Shock	1.3% 1/78 • 5 years
Vascular disorders Vascular Injury	1.3% 1/78 • 5 years
Vascular disorders Vascular disorders: Other	9.0% 7/78 • 5 years

Other adverse events

Measure	High Risk Registry Arm n=78 participants at risk Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant. Percutaneous mitral valve repair using MitraClip implant: Procedure/Surgery: Mitral valve repair or replacement surgery Repair or replacement of mitral valve
Blood and lymphatic system disorders Anemia	33.3% 26/78 • 5 years
Blood and lymphatic system disorders Hemolysis	14.1% 11/78 • 5 years
Blood and lymphatic system disorders Thrombocytopenia	7.7% 6/78 • 5 years
Cardiac disorders Atrial arrhythmia	12.8% 10/78 • 5 years
Cardiac disorders Atrial septal defect	5.1% 4/78 • 5 years
Cardiac disorders Bradyarrhythmia	5.1% 4/78 • 5 years
Cardiac disorders Cardiac disorders: other	5.1% 4/78 • 5 years
Cardiac disorders Chest pain/Angina	28.2% 22/78 • 5 years
Cardiac disorders Congestive heart failure	24.4% 19/78 • 5 years
Cardiac disorders Myocardial ischemia	11.5% 9/78 • 5 years
Cardiac disorders Other rhythm disorder	10.3% 8/78 • 5 years
Cardiac disorders Peripheral edema	25.6% 20/78 • 5 years
Cardiac disorders Residual/recurrent magnetic resonance (MR)	19.2% 15/78 • 5 years
Cardiac disorders Syncope/Dizziness	24.4% 19/78 • 5 years
Cardiac disorders Ventricular arrhythmia	7.7% 6/78 • 5 years
Cardiac disorders cardiomyopathy	5.1% 4/78 • 5 years
Gastrointestinal disorders Abdominal pain	5.1% 4/78 • 5 years
Gastrointestinal disorders Bleed	5.1% 4/78 • 5 years
Gastrointestinal disorders Dysphagia	10.3% 8/78 • 5 years
Gastrointestinal disorders Gastrointestinal disorders: Other	38.5% 30/78 • 5 years
Gastrointestinal disorders Infection	10.3% 8/78 • 5 years
General disorders Fever	7.7% 6/78 • 5 years
General disorders General disorders: Other	48.7% 38/78 • 5 years
General disorders Generalized weakness/Fatigue	30.8% 24/78 • 5 years
General disorders Incisional site pain	16.7% 13/78 • 5 years
General disorders Infection	7.7% 6/78 • 5 years
General disorders Mental disorders	17.9% 14/78 • 5 years
General disorders Metabolic/Endocrine disorders	33.3% 26/78 • 5 years
General disorders Skin/Mucosal/Subcutaneous tissue disorders	12.8% 10/78 • 5 years
Musculoskeletal and connective tissue disorders Connective tissue disorders	47.4% 37/78 • 5 years
Nervous system disorders Nervous system disorders: Other	23.1% 18/78 • 5 years
Nervous system disorders Transient ischemic attack (TIA)	5.1% 4/78 • 5 years
Renal and urinary disorders Renal Infection	12.8% 10/78 • 5 years
Renal and urinary disorders Renal and urinary disorders: Other	15.4% 12/78 • 5 years
Renal and urinary disorders Renal insufficiency/Failure	19.2% 15/78 • 5 years
Respiratory, thoracic and mediastinal disorders Bronchial/Lung disorders	10.3% 8/78 • 5 years
Respiratory, thoracic and mediastinal disorders Pleural effusion	20.5% 16/78 • 5 years
Respiratory, thoracic and mediastinal disorders Pneumonia	7.7% 6/78 • 5 years
Respiratory, thoracic and mediastinal disorders Respiratory Infection	11.5% 9/78 • 5 years
Respiratory, thoracic and mediastinal disorders Respiratory failure	6.4% 5/78 • 5 years
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders: Other	38.5% 30/78 • 5 years
Vascular disorders Bleeding complication	43.6% 34/78 • 5 years
Vascular disorders Blood pressure complication	5.1% 4/78 • 5 years
Vascular disorders Bruise/Contusion/Ecchymosis	23.1% 18/78 • 5 years
Vascular disorders Hematoma	24.4% 19/78 • 5 years
Vascular disorders Hemodynamic instability	26.9% 21/78 • 5 years
Vascular disorders Vascular disorders: Other	10.3% 8/78 • 5 years

Additional Information

Chithra Sangli

Abbott Vascular Structural Heart (formerly Evalve, Inc.)

Phone: 650-430-1329

Email: chithra.sangli@av.abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60