Trial Outcomes & Findings for Pivotal Study of a Percutaneous Mitral Valve Repair System (NCT NCT00209274)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

279 participants

Primary outcome timeframe

30 days

Results posted on

2018-11-07

Participant Flow

The EVEREST II RCT was conducted in patients who were indicated for and could undergo mitral valve surgery. A total of 279 patients were enrolled at United States \& Canada investigational sites between Aug 5,2005 to Sep 17,2008 time period. The subjects were randomized to Device group (n=184; MitraClip) \&Control group (n=95;Mitral Valve Surgery).

The EVEREST II RCT enrolled 279 patients (184 Device and 95 Control), of whom 21 patients (6 Device and 15 Control) did not undergo treatment per their randomized assignment, and are reported as "randomized not treated" (RNT). All RNT patients except one withdrew from the trial.

Participant milestones

Participant milestones
Measure	Device Group (MitraClip Device) Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) Mitral valve repair or replacement surgery.
Overall Study STARTED	184	95
Overall Study COMPLETED	113	48
Overall Study NOT COMPLETED	71	47

Reasons for withdrawal

Reasons for withdrawal
Measure	Device Group (MitraClip Device) Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) Mitral valve repair or replacement surgery.
Overall Study Missed visit	3	2
Overall Study Death	32	15
Overall Study Withdrawal by Subject	30	15
Overall Study Randomized not treated (RNT)	6	15

Baseline Characteristics

Pivotal Study of a Percutaneous Mitral Valve Repair System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Device Group (MitraClip Device) n=184 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=95 Participants Mitral valve repair or replacement surgery.	Total n=279 Participants Total of all reporting groups
Age, Continuous	67.3 years STANDARD_DEVIATION 12.8 • n=5 Participants	65.7 years STANDARD_DEVIATION 12.9 • n=7 Participants	66.7 years STANDARD_DEVIATION 12.8 • n=5 Participants
Age, Customized 18-75 years	129 Participants n=5 Participants	69 Participants n=7 Participants	198 Participants n=5 Participants
Age, Customized >75 years	55 Participants n=5 Participants	26 Participants n=7 Participants	81 Participants n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants	32 Participants n=7 Participants	101 Participants n=5 Participants
Sex: Female, Male Male	115 Participants n=5 Participants	63 Participants n=7 Participants	178 Participants n=5 Participants
Region of Enrollment United States	177 Participants n=5 Participants	93 Participants n=7 Participants	270 Participants n=5 Participants
Region of Enrollment Canada	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
NYHA Functional Class NYHA Functional Class I	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
NYHA Functional Class NYHA Functional Class II	73 Participants n=5 Participants	31 Participants n=7 Participants	104 Participants n=5 Participants
NYHA Functional Class NYHA Functional Class III	82 Participants n=5 Participants	41 Participants n=7 Participants	123 Participants n=5 Participants
NYHA Functional Class NYHA Functional Class IV	12 Participants n=5 Participants	4 Participants n=7 Participants	16 Participants n=5 Participants
Mitral regurgitation (MR) 0: None	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Mitral regurgitation (MR) 1+: Mild	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Mitral regurgitation (MR) 2+: Moderate	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Mitral regurgitation (MR) 3+: Moderate-to-Severe	130 Participants n=5 Participants	67 Participants n=7 Participants	197 Participants n=5 Participants
Mitral regurgitation (MR) 4+: Severe	46 Participants n=5 Participants	21 Participants n=7 Participants	67 Participants n=5 Participants
Left Ventricular (LV) Measurement LV End Diastolic Volume (LVEDV)	156.5 mL STANDARD_DEVIATION 39.0 • n=5 Participants	159.6 mL STANDARD_DEVIATION 46.3 • n=7 Participants	158.05 mL STANDARD_DEVIATION 42.65 • n=5 Participants
Left Ventricular (LV) Measurement LV End Systolic Volume (LVESV)	63.5 mL STANDARD_DEVIATION 25.5 • n=5 Participants	63.8 mL STANDARD_DEVIATION 28.9 • n=7 Participants	63.65 mL STANDARD_DEVIATION 27.20 • n=5 Participants
Left Ventricular (LV) Measurement LV internal dimension diastole (LVIDd)	5.5 cm STANDARD_DEVIATION 0.7 • n=5 Participants	5.5 cm STANDARD_DEVIATION 0.7 • n=7 Participants	5.5 cm STANDARD_DEVIATION 0.7 • n=5 Participants
Left Ventricular (LV) Measurement LV internal dimension systole (LVIDs)	3.7 cm STANDARD_DEVIATION 0.9 • n=5 Participants	3.5 cm STANDARD_DEVIATION 0.8 • n=7 Participants	3.6 cm STANDARD_DEVIATION 0.85 • n=5 Participants
36-Item Short Form Health Survey (SF-36) Quality of Life (QOL) Physical Component Score	41.1 scores on a scale STANDARD_DEVIATION 10.0 • n=5 Participants	41.9 scores on a scale STANDARD_DEVIATION 11.1 • n=7 Participants	41.4 scores on a scale STANDARD_DEVIATION 10.3 • n=5 Participants
36-Item Short Form Health Survey (SF-36) Quality of Life (QOL) Mental Component Score	47.1 scores on a scale STANDARD_DEVIATION 11.9 • n=5 Participants	46.6 scores on a scale STANDARD_DEVIATION 12.5 • n=7 Participants	46.9 scores on a scale STANDARD_DEVIATION 12.0 • n=5 Participants

PRIMARY outcome

Timeframe: 30 days

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=136 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=79 Participants Mitral valve repair or replacement surgery.
Number of Participants With Major Adverse Events (MAE)	13 Participants	45 Participants

PRIMARY outcome

Timeframe: 12 months

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=134 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=74 Participants Mitral valve repair or replacement surgery.
Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).	97 Participants	65 Participants

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=158 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=70 Participants Mitral valve repair or replacement surgery.
Freedom From All-Cause Mortality	93.7 Percentage of participants	92.3 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.

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=143 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=65 Participants Mitral valve repair or replacement surgery.
Freedom From All-Cause Mortality	90.0 Percentage of participants	89.6 Percentage of participants

SECONDARY outcome

Timeframe: 3 years

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=133 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=57 Participants Mitral valve repair or replacement surgery.
Freedom From All-Cause Mortality	87.5 Percentage of participants	85.3 Percentage of participants

SECONDARY outcome

Timeframe: 4 years

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=119 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=52 Participants Mitral valve repair or replacement surgery.
Freedom From All-Cause Mortality	83.4 Percentage of participants	82.3 Percentage of participants

SECONDARY outcome

Timeframe: 5 years

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=58 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=24 Participants Mitral valve repair or replacement surgery.
Freedom From All-Cause Mortality	81.2 Percentage of participants	79 Percentage of participants

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=175 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=89 Participants Mitral valve repair or replacement surgery.
Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation.	118 Participants	65 Participants

SECONDARY outcome

Timeframe: 24 months

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=126 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=68 Participants Mitral valve repair or replacement surgery.
Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).	87 Participants	55 Participants

SECONDARY outcome

Timeframe: 24 months

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=161 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=83 Participants Mitral valve repair or replacement surgery.
Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR) in Intention to Treat Strategy Cohort	100 participants	56 participants

SECONDARY outcome

Timeframe: At discharge (≤ 14 days following index procedure) or 30 days

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=170 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=77 Participants Mitral valve repair or replacement surgery.
Left Ventricular Ejection Fraction (LVEF)	56.9 Percentage of volume ejected Standard Deviation 10.0	53.9 Percentage of volume ejected Standard Deviation 10.9

SECONDARY outcome

Timeframe: 12 months

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

LVEF as determined by the core echo laboratory.

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=144 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=65 Participants Mitral valve repair or replacement surgery.
Left Ventricular Ejection Fraction (LVEF)	58.0 Percentage of volume ejected Standard Deviation 8.7	55.3 Percentage of volume ejected Standard Deviation 10.2

SECONDARY outcome

Timeframe: 24 months

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

LVEF as determined by the core echo laboratory.

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=125 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=56 Participants Mitral valve repair or replacement surgery.
Left Ventricular Ejection Fraction (LVEF)	56.9 Percentage of volume ejected Standard Deviation 8.3	55.8 Percentage of volume ejected Standard Deviation 8.1

SECONDARY outcome

Timeframe: 3 years

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

LVEF as determined by the core echo laboratory.

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=119 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=47 Participants Mitral valve repair or replacement surgery.
Left Ventricular Ejection Fraction (LVEF)	57.0 Percentage of volume ejected Standard Deviation 9.1	58.4 Percentage of volume ejected Standard Deviation 9.2

SECONDARY outcome

Timeframe: 4 years

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

LVEF as determined by the core echo laboratory.

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=102 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=45 Participants Mitral valve repair or replacement surgery.
Left Ventricular Ejection Fraction (LVEF)	57.6 Percentage of volume ejected Standard Deviation 9.9	58.9 Percentage of volume ejected Standard Deviation 10.2

SECONDARY outcome

Timeframe: 5 years

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

LVEF as determined by the core echo laboratory.

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=105 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=40 Participants Mitral valve repair or replacement surgery.
Left Ventricular Ejection Fraction (LVEF)	56.5 Percentage of volume ejected Standard Deviation 10.1	57 Percentage of volume ejected Standard Deviation 9.3

SECONDARY outcome

Timeframe: 30 days

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=170 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=77 Participants Mitral valve repair or replacement surgery.
Left Ventricular Status- Left Ventricular End-diastolic Volume (LVEDV), Left Ventricular End-systolic Volume (LVESV) LVEDV	144.7 ml Standard Deviation 40.0	130.8 ml Standard Deviation 40.5
Left Ventricular Status- Left Ventricular End-diastolic Volume (LVEDV), Left Ventricular End-systolic Volume (LVESV) LVESV	63.7 ml Standard Deviation 27.2	62.0 ml Standard Deviation 29.2

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=144 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=65 Participants Mitral valve repair or replacement surgery.
Left Ventricular Status- LVEDV, LVESV LVEDV	133.7 ml Standard Deviation 35.5	120.9 ml Standard Deviation 44.3
Left Ventricular Status- LVEDV, LVESV LVESV	57.5 ml Standard Deviation 24.0	56.2 ml Standard Deviation 31.4

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=125 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=56 Participants Mitral valve repair or replacement surgery.
Left Ventricular Status- LVEDV, LVESV LVEDV	123.4 mL Standard Deviation 35.0	110.5 mL Standard Deviation 40.9
Left Ventricular Status- LVEDV, LVESV LVESV	54.7 mL Standard Deviation 24.7	50.4 mL Standard Deviation 26.3

SECONDARY outcome

Timeframe: 3 years

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=119 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=47 Participants Mitral valve repair or replacement surgery.
Left Ventricular Status- LVEDV, LVESV LVEDV	130.6 ml Standard Deviation 32.6	112.7 ml Standard Deviation 40.2
Left Ventricular Status- LVEDV, LVESV LVESV	57.7 ml Standard Deviation 24.7	48.0 ml Standard Deviation 24.7

SECONDARY outcome

Timeframe: 4 years

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=102 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=45 Participants Mitral valve repair or replacement surgery.
Left Ventricular Status- LVEDV, LVESV LVEDV	126.6 ml Standard Deviation 33.1	112.7 ml Standard Deviation 40.4
Left Ventricular Status- LVEDV, LVESV LVESV	55.0 ml Standard Deviation 24.4	48.1 ml Standard Deviation 26.9

SECONDARY outcome

Timeframe: 5 years

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=105 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=40 Participants Mitral valve repair or replacement surgery.
Left Ventricular Status- LVEDV, LVESV LVEDV	126.3 ml Standard Deviation 32.5	112.9 ml Standard Deviation 37.8
Left Ventricular Status- LVEDV, LVESV LVESV	56.1 ml Standard Deviation 23	50.1 ml Standard Deviation 26.3

SECONDARY outcome

Timeframe: 30 days

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=169 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=77 Participants Mitral valve repair or replacement surgery.
Left Ventricular Internal Dimension Systole (LVIDs)	3.6 cm Standard Deviation 0.9	3.5 cm Standard Deviation 0.8

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=146 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=66 Participants Mitral valve repair or replacement surgery.
Left Ventricular Internal Dimension Systole (LVIDs)	3.5 cm Standard Deviation 0.8	3.3 cm Standard Deviation 0.8

SECONDARY outcome

Timeframe: 2 years

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=125 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=58 Participants Mitral valve repair or replacement surgery.
Left Ventricular Internal Dimension Systole (LVIDs)	3.4 cm Standard Deviation 0.8	3.2 cm Standard Deviation 0.9

SECONDARY outcome

Timeframe: 3 years

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=120 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=50 Participants Mitral valve repair or replacement surgery.
Left Ventricular Internal Dimension Systole (LVIDs)	3.6 cm Standard Deviation 0.9	3.2 cm Standard Deviation 0.8

SECONDARY outcome

Timeframe: 4 years

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=102 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=46 Participants Mitral valve repair or replacement surgery.
Left Ventricular Internal Dimension Systole (LVIDs)	3.6 cm Standard Deviation 0.9	3.3 cm Standard Deviation 0.8

SECONDARY outcome

Timeframe: 5 years

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=104 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=42 Participants Mitral valve repair or replacement surgery.
Left Ventricular Internal Dimension Systole (LVIDs)	3.6 cm Standard Deviation 0.9	3.3 cm Standard Deviation 0.9

SECONDARY outcome

Timeframe: 30 days

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=171 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=77 Participants Mitral valve repair or replacement surgery.
Left Ventricular Internal Dimension Diastole (LVIDd)	5.3 cm Standard Deviation 0.7	5.0 cm Standard Deviation 0.7

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=148 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=66 Participants Mitral valve repair or replacement surgery.
Left Ventricular Internal Dimension Diastole (LVIDd)	5.1 cm Standard Deviation 0.7	4.8 cm Standard Deviation 0.7

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=127 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=58 Participants Mitral valve repair or replacement surgery.
Left Ventricular Internal Dimension Diastole (LVIDd)	5.0 cm Standard Deviation 0.7	4.7 cm Standard Deviation 0.8

SECONDARY outcome

Timeframe: 3 years

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=122 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=50 Participants Mitral valve repair or replacement surgery.
Left Ventricular Internal Dimension Diastole (LVIDd)	5.2 cm Standard Deviation 0.7	4.8 cm Standard Deviation 0.7

SECONDARY outcome

Timeframe: 4 years

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=102 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=46 Participants Mitral valve repair or replacement surgery.
Left Ventricular Internal Dimension Diastole (LVIDd)	5.3 cm Standard Deviation 0.6	4.8 cm Standard Deviation 0.7

SECONDARY outcome

Timeframe: 5 years

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=106 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=42 Participants Mitral valve repair or replacement surgery.
Left Ventricular Internal Dimension Diastole (LVIDd)	5.2 cm Standard Deviation 0.6	4.9 cm Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline

Population: ITT population.

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

Outcome measures
Measure	Device Group (MitraClip Device) n=184 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=95 Participants Mitral valve repair or replacement surgery.
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. NYHA Functional Class I	17 Participants	19 Participants
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. NYHA Functional Class II	73 Participants	31 Participants
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. NYHA Functional Class III	82 Participants	41 Participants
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. NYHA Functional Class IV	12 Participants	4 Participants

SECONDARY outcome

Timeframe: 30 days

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

Outcome measures
Measure	Device Group (MitraClip Device) n=168 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=75 Participants Mitral valve repair or replacement surgery.
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. NYHA Functional Class I	84 Participants	40 Participants
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. NYHA Functional Class IV	0 Participants	0 Participants
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. NYHA Functional Class II	67 Participants	28 Participants
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. NYHA Functional Class III	17 Participants	7 Participants

SECONDARY outcome

Timeframe: 12 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

Outcome measures
Measure	Device Group (MitraClip Device) n=151 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=66 Participants Mitral valve repair or replacement surgery.
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. NYHA Functional Class I	104 Participants	46 Participants
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. NYHA Functional Class II	44 Participants	12 Participants
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. NYHA Functional Class III	3 Participants	7 Participants
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. NYHA Functional Class IV	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 24 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

Outcome measures
Measure	Device Group (MitraClip Device) n=132 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=60 Participants Mitral valve repair or replacement surgery.
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. NYHA Functional Class I	89 Participants	43 Participants
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. NYHA Functional Class II	42 Participants	11 Participants
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. NYHA Functional Class III	1 Participants	4 Participants
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. NYHA Functional Class IV	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 3 years

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

Outcome measures
Measure	Device Group (MitraClip Device) n=120 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=50 Participants Mitral valve repair or replacement surgery.
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. NYHA Functional Class I	84 Participants	41 Participants
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. NYHA Functional Class II	32 Participants	8 Participants
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. NYHA Functional Class III	4 Participants	1 Participants
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. NYHA Functional Class IV	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 4 years

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

Outcome measures
Measure	Device Group (MitraClip Device) n=105 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=48 Participants Mitral valve repair or replacement surgery.
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. NYHA Functional Class I	70 Participants	35 Participants
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. NYHA Functional Class II	29 Participants	10 Participants
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. NYHA Functional Class III	6 Participants	3 Participants
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. NYHA Functional Class IV	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 5 years

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

Outcome measures
Measure	Device Group (MitraClip Device) n=106 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=42 Participants Mitral valve repair or replacement surgery.
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. NYHA Functional Class II	27 Participants	8 Participants
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. NYHA Functional Class I	70 Participants	33 Participants
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. NYHA Functional Class III	9 Participants	1 Participants
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. NYHA Functional Class IV	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

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

Outcome measures
Measure	Device Group (MitraClip Device) n=168 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=75 Participants Mitral valve repair or replacement surgery.
New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV	10.1 Percentage of participants	9.3 Percentage of participants

SECONDARY outcome

Timeframe: 12 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

Outcome measures
Measure	Device Group (MitraClip Device) n=151 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=66 Participants Mitral valve repair or replacement surgery.
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV	2.0 Percentage of participants	12.1 Percentage of participants

SECONDARY outcome

Timeframe: 2 years

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

Outcome measures
Measure	Device Group (MitraClip Device) n=132 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=60 Participants Mitral valve repair or replacement surgery.
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV	0.8 Percentage of participants	10.0 Percentage of participants

SECONDARY outcome

Timeframe: 3 years

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

Outcome measures
Measure	Device Group (MitraClip Device) n=120 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=50 Participants Mitral valve repair or replacement surgery.
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV	3.3 Percentage of participants	2.0 Percentage of participants

SECONDARY outcome

Timeframe: 4 years

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

Outcome measures
Measure	Device Group (MitraClip Device) n=105 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=48 Participants Mitral valve repair or replacement surgery.
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV	5.7 Percentage of participants	6.3 Percentage of participants

SECONDARY outcome

Timeframe: 5 years

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

Outcome measures
Measure	Device Group (MitraClip Device) n=106 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=42 Participants Mitral valve repair or replacement surgery.
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV	8.5 Percentage of participants	2.4 Percentage of participants

SECONDARY outcome

Timeframe: 30 days

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=159 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=68 Participants Mitral valve repair or replacement surgery.
Short Form (SF)-36 Quality of Life Questionnaire. Physical Component Summary	43.8 scores on a scale Standard Deviation 9.8	36.9 scores on a scale Standard Deviation 9.9
Short Form (SF)-36 Quality of Life Questionnaire. Mental Component Summary	50.8 scores on a scale Standard Deviation 10.8	46.7 scores on a scale 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.

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=139 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=64 Participants Mitral valve repair or replacement surgery.
Short Form (SF)-36 Quality of Life Questionnaire. Physical Component Summary	46.8 scores on a scale Standard Deviation 9.5	46.5 scores on a scale Standard Deviation 10.6
Short Form (SF)-36 Quality of Life Questionnaire. Mental Component Summary	52.9 scores on a scale Standard Deviation 8.0	50.4 scores on a scale Standard Deviation 10.9

SECONDARY outcome

Timeframe: 30 days

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

Cardiac output as measured by core lab echocardiography.

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=162 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=71 Participants Mitral valve repair or replacement surgery.
Cardiac Output	4.2 L/min Standard Deviation 1.2	4.8 L/min Standard Deviation 1.3

SECONDARY outcome

Timeframe: 12 months

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

Cardiac output as measured by core lab echocardiography.

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=147 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=67 Participants Mitral valve repair or replacement surgery.
Cardiac Output	4.4 L/min Standard Deviation 1.3	4.6 L/min Standard Deviation 1.4

SECONDARY outcome

Timeframe: 24 months

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

Cardiac output as measured by core lab echocardiography.

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=121 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=57 Participants Mitral valve repair or replacement surgery.
Cardiac Output	4.0 L/min Standard Deviation 1.1	4.1 L/min Standard Deviation 1.1

SECONDARY outcome

Timeframe: 30 days

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=158 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=71 Participants Mitral valve repair or replacement surgery.
Cardiac Index	2.2 L/min/m^2 Standard Deviation 0.6	2.5 L/min/m^2 Standard Deviation 0.6

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=145 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=65 Participants Mitral valve repair or replacement surgery.
Cardiac Index (CI)	2.3 L/min/m^2 Standard Deviation 0.6	2.4 L/min/m^2 Standard Deviation 0.6

SECONDARY outcome

Timeframe: 24 months

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=121 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=56 Participants Mitral valve repair or replacement surgery.
Cardiac Index	2.1 L/min/m^2 Standard Deviation 0.5	2.1 L/min/m^2 Standard Deviation 0.5

SECONDARY outcome

Timeframe: 30 Days

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=131 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=45 Participants Mitral valve repair or replacement surgery.
Regurgitant Volume	22.7 mL Standard Deviation 17.6	13.1 mL Standard Deviation 10.7

SECONDARY outcome

Timeframe: 12 months

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

Regurgitant volume as determined by the core echo laboratory.

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=115 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=34 Participants Mitral valve repair or replacement surgery.
Regurgitant Volume	19.9 mL Standard Deviation 14.4	14.6 mL Standard Deviation 10.5

SECONDARY outcome

Timeframe: 24 months

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

Regurgitant volume as determined by the core echo laboratory.

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=85 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=25 Participants Mitral valve repair or replacement surgery.
Regurgitant Volume	19.4 mL Standard Deviation 13.2	15.7 mL Standard Deviation 10.5

SECONDARY outcome

Timeframe: 30 Days

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=131 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=45 Participants Mitral valve repair or replacement surgery.
Regurgitant Fraction (RF)	25.4 percentage of LV stroke volume Standard Deviation 15.3	17.3 percentage of LV stroke volume Standard Deviation 13.1

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=115 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=34 Participants Mitral valve repair or replacement surgery.
Regurgitant Fraction	22.8 Percentage of LV stroke volume Standard Deviation 13.8	19.2 Percentage of LV stroke volume Standard Deviation 12.1

SECONDARY outcome

Timeframe: 24 months

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=85 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=25 Participants Mitral valve repair or replacement surgery.
Regurgitant Fraction	24.5 Percentage of LV stroke volume Standard Deviation 13.3	20.4 Percentage of LV stroke volume Standard Deviation 10.9

SECONDARY outcome

Timeframe: Day 0

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=178 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) Mitral valve repair or replacement surgery.
Number of Participants With Clip Implant Rate	158 Participants	—

SECONDARY outcome

Timeframe: 30 Days

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=184 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) Mitral valve repair or replacement surgery.
Number of Participants With Acute Procedural Success	137 Participants	—

SECONDARY outcome

Timeframe: 30 Days

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

Defined as successful mitral valve repair or replacement surgery.

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=80 Participants Mitral valve repair or replacement surgery.
Number of Participants With Acute Surgical Success	—	80 Participants

SECONDARY outcome

Timeframe: 30 days

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=178 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) Mitral valve repair or replacement surgery.
Number of Participants With Successful Clip Implant and Acute Procedural Success Device Implant Rate	158 Participants	—
Number of Participants With Successful Clip Implant and Acute Procedural Success Acute Procedural Success	137 Participants	—

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=177 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=91 Participants Mitral valve repair or replacement surgery.
Number of Participants With Mitral Valve Repair Success.	114 Participants	57 Participants

SECONDARY outcome

Timeframe: 24 months

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=167 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=84 Participants Mitral valve repair or replacement surgery.
Number of Participants With Mitral Valve Repair Success.	103 Participants	46 Participants

SECONDARY outcome

Timeframe: Day 0

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=178 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=80 Participants Mitral valve repair or replacement surgery.
Number of Participants With Procedural Freedom From In-hospital MAE.	168 Participants	41 Participants

SECONDARY outcome

Timeframe: Day 30

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=178 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=80 Participants Mitral valve repair or replacement surgery.
Number of Participants With Procedural Freedom From In-hospital MAE	10 Participants	39 Participants

SECONDARY outcome

Timeframe: 30 days

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=37 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=80 Participants Mitral valve repair or replacement surgery.
Number of Participants With MAE: Surgery After Device and First Time Surgery Control	14 Participants	40 Participants

SECONDARY outcome

Timeframe: 30 days

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

Vascular Complications defined as the occurrence of any of the following resulting through 30 days or hospital discharge, whichever is longer: * Hematoma at access site \>6 cm; * Retroperitoneal hematoma; * Arteriovenous (AV) fistula; * Symptomatic peripheral ischemia / nerve injury or the clinical signs or symptoms lasting \>48 hours; * Vascular Surgical Repair at catheter access sites; * Pulmonary embolism; * Ipsilateral deep vein thrombus; or * Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=184 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=95 Participants Mitral valve repair or replacement surgery.
Number of Participants With Major Vascular Complications	9 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months

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

Vascular Complications defined as the occurrence of any of the following resulting through 30 days or hospital discharge, whichever is longer: * Hematoma at access site \>6 cm; * Retroperitoneal hematoma; * Arteriovenous (AV) fistula; * Symptomatic peripheral ischemia / nerve injury or the clinical signs or symptoms lasting \>48 hours; * Vascular Surgical Repair at catheter access sites; * Pulmonary embolism; * Ipsilateral deep vein thrombus; or * Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=184 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=95 Participants Mitral valve repair or replacement surgery.
Number of Participants With Major Vascular Complications	11 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=184 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=95 Participants Mitral valve repair or replacement surgery.
Number of Participants With Major Bleeding Complications.	9 Participants	38 Participants

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=184 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=95 Participants Mitral valve repair or replacement surgery.
Number of Participants With Major Bleeding Complications.	17 Participants	39 Participants

SECONDARY outcome

Timeframe: 12 months.

Population: Intent to treat (ITT) population.

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=184 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=95 Participants Mitral valve repair or replacement surgery.
Number of Participants With Major Adverse Events (MAE)	39 Participants	44 Participants

SECONDARY outcome

Timeframe: 30 days

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=55 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=26 Participants Mitral valve repair or replacement surgery.
Number of Participants With MAE in Patients Over 75 Years of Age.	9 Participants	12 Participants

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=55 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=26 Participants Mitral valve repair or replacement surgery.
Number of Participants With MAE in Patients Over 75 Years of Age.	14 Participants	14 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT population.

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=184 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=95 Participants Mitral valve repair or replacement surgery.
Number of Participants With Dysrhythmia	9 Participants	22 Participants

SECONDARY outcome

Timeframe: 12 months

Population: ITT population.

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=184 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=95 Participants Mitral valve repair or replacement surgery.
Number of Participants With Dysrhythmia	22 Participants	22 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT population.

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=184 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=95 Participants Mitral valve repair or replacement surgery.
Number of Participants With Endocarditis.	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 12 months

Population: ITT population.

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=184 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=95 Participants Mitral valve repair or replacement surgery.
Number of Participants With Endocarditis.	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT population.

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=184 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=95 Participants Mitral valve repair or replacement surgery.
Number of Participants With Thrombosis.	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months

Population: ITT population.

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=184 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=95 Participants Mitral valve repair or replacement surgery.
Number of Participants With Thrombosis.	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT population.

Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on repeat measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms. Reported as major or minor as defined below: Major: Requires intervention with red blood cell transfusion or other hematocrit increasing measures in the absence of other obvious bleeding. Minor: Does not require intervention.

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=184 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=95 Participants Mitral valve repair or replacement surgery.
Number of Participants With Hemolysis	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months

Population: ITT population.

Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on repeat measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms. Reported as major or minor as defined below: Major: Requires intervention with red blood cell transfusion or other hematocrit increasing measures in the absence of other obvious bleeding. Minor: Does not require intervention.

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=184 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=95 Participants Mitral valve repair or replacement surgery.
Number of Participants With Hemolysis	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT population.

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=184 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=95 Participants Mitral valve repair or replacement surgery.
Number of Participants With Clinically Significant Atrial Septal Defect (ASD).	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months

Population: ITT population.

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=184 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=95 Participants Mitral valve repair or replacement surgery.
Number of Participants With Clinically Significant Atrial Septal Defect (ASD)	4 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT population.

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=184 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=95 Participants Mitral valve repair or replacement surgery.
Number of Participants With Mitral Valve Stenosis	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months

Population: ITT population.

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=184 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=95 Participants Mitral valve repair or replacement surgery.
Number of Participants With Mitral Valve Stenosis	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 months

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=178 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=80 Participants Mitral valve repair or replacement surgery.
Number of Participants With Mitral Valve Stenosis	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 3 years

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=178 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=80 Participants Mitral valve repair or replacement surgery.
Number of Participants With Mitral Valve Stenosis Conservative cases	3 Participants	0 Participants
Number of Participants With Mitral Valve Stenosis Confirmed cases	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 4 years

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=178 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=80 Participants Mitral valve repair or replacement surgery.
Number of Participants With Mitral Valve Stenosis Conservative cases	3 Participants	0 Participants
Number of Participants With Mitral Valve Stenosis Confirmed cases	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 5 years

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=178 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=80 Participants Mitral valve repair or replacement surgery.
Number of Participants With Mitral Valve Stenosis Conservative cases	4 Participants	2 Participants
Number of Participants With Mitral Valve Stenosis Confirmed cases	1 Participants	0 Participants

SECONDARY outcome

Timeframe: At Discharge (≤14 days of index procedure)

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

Outcome measures
Measure	Device Group (MitraClip Device) n=140 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=59 Participants Mitral valve repair or replacement surgery.
Mitral Valve Area by Planimetry	3.7 cm^2 Standard Deviation 1.4	3.6 cm^2 Standard Deviation 0.9

SECONDARY outcome

Timeframe: 30 Days

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

Outcome measures
Measure	Device Group (MitraClip Device) n=121 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=53 Participants Mitral valve repair or replacement surgery.
Mitral Valve Area by Planimetry	3.6 cm^2 Standard Deviation 1.1	3.9 cm^2 Standard Deviation 1.2

SECONDARY outcome

Timeframe: 12 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

Outcome measures
Measure	Device Group (MitraClip Device) n=100 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=47 Participants Mitral valve repair or replacement surgery.
Mitral Valve Area by Planimetry	3.2 cm^2 Standard Deviation 1.0	3.7 cm^2 Standard Deviation 1.1

SECONDARY outcome

Timeframe: 24 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

Outcome measures
Measure	Device Group (MitraClip Device) n=90 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=35 Participants Mitral valve repair or replacement surgery.
Mitral Valve Area by Planimetry	3.3 cm^2 Standard Deviation 0.9	3.3 cm^2 Standard Deviation 0.8

SECONDARY outcome

Timeframe: 3 years

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

Outcome measures
Measure	Device Group (MitraClip Device) n=81 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=34 Participants Mitral valve repair or replacement surgery.
Mitral Valve Area by Planimetry	3.3 cm^2 Standard Deviation 0.9	3.6 cm^2 Standard Deviation 0.9

SECONDARY outcome

Timeframe: 4 years

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

Outcome measures
Measure	Device Group (MitraClip Device) n=82 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=31 Participants Mitral valve repair or replacement surgery.
Mitral Valve Area by Planimetry	3.2 cm^2 Standard Deviation 0.9	3.8 cm^2 Standard Deviation 0.8

SECONDARY outcome

Timeframe: 5 years

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

Outcome measures
Measure	Device Group (MitraClip Device) n=75 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=30 Participants Mitral valve repair or replacement surgery.
Mitral Valve Area by Planimetry	3.2 cm^2 Standard Deviation 1.0	3.7 cm^2 Standard Deviation 1.0

SECONDARY outcome

Timeframe: 30 Days

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=118 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=53 Participants Mitral valve repair or replacement surgery.
Mitral Valve Area by Planimetry Index	1.9 cm^2/m^2 Standard Deviation 0.6	2.0 cm^2/m^2 Standard Deviation 0.5

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=105 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=48 Participants Mitral valve repair or replacement surgery.
Mitral Valve Area by Planimetry Index	1.7 cm^2/m^2 Standard Deviation 0.5	1.9 cm^2/m^2 Standard Deviation 0.6

SECONDARY outcome

Timeframe: 24 months

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=92 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=36 Participants Mitral valve repair or replacement surgery.
Mitral Valve Area by Planimetry Index	1.7 cm^2/m^2 Standard Deviation 0.4	1.8 cm^2/m^2 Standard Deviation 0.6

SECONDARY outcome

Timeframe: At Discharge (≤14 days of index procedure)

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

Outcome measures
Measure	Device Group (MitraClip Device) n=166 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=71 Participants Mitral valve repair or replacement surgery.
Mitral Valve Area by Pressure Half-time	3.0 cm^2 Standard Deviation 1.1	3.3 cm^2 Standard Deviation 1.1

SECONDARY outcome

Timeframe: 30 days

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

Outcome measures
Measure	Device Group (MitraClip Device) n=156 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=66 Participants Mitral valve repair or replacement surgery.
Mitral Valve Area by Pressure Half-time	2.8 cm^2 Standard Deviation 1.0	3.5 cm^2 Standard Deviation 1.2

SECONDARY outcome

Timeframe: 12 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

Outcome measures
Measure	Device Group (MitraClip Device) n=140 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=63 Participants Mitral valve repair or replacement surgery.
Mitral Valve Area by Pressure Half-time	2.9 cm^2 Standard Deviation 1.0	3.1 cm^2 Standard Deviation 1.1

SECONDARY outcome

Timeframe: 24 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

Outcome measures
Measure	Device Group (MitraClip Device) n=121 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=52 Participants Mitral valve repair or replacement surgery.
Mitral Valve Area by Pressure Half-time	2.7 cm^2 Standard Deviation 0.7	2.8 cm^2 Standard Deviation 0.7

SECONDARY outcome

Timeframe: 3 years

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

Outcome measures
Measure	Device Group (MitraClip Device) n=120 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=48 Participants Mitral valve repair or replacement surgery.
Mitral Valve Area by Pressure Half-time	2.7 cm^2 Standard Deviation 0.7	2.8 cm^2 Standard Deviation 0.6

SECONDARY outcome

Timeframe: 4 years

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

Outcome measures
Measure	Device Group (MitraClip Device) n=102 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=48 Participants Mitral valve repair or replacement surgery.
Mitral Valve Area by Pressure Half-time	2.9 cm^2 Standard Deviation 0.8	3.0 cm^2 Standard Deviation 1.0

SECONDARY outcome

Timeframe: 5 years

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

Outcome measures
Measure	Device Group (MitraClip Device) n=101 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=41 Participants Mitral valve repair or replacement surgery.
Mitral Valve Area by Pressure Half-time	2.7 cm^2 Standard Deviation 0.7	2.8 cm^2 Standard Deviation 0.7

SECONDARY outcome

Timeframe: 30 Days

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=153 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=66 Participants Mitral valve repair or replacement surgery.
Mitral Valve Area by Pressure Half-time Index	1.5 cm^2/m^2 Standard Deviation 0.6	1.9 cm^2/m^2 Standard Deviation 0.7

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=142 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=65 Participants Mitral valve repair or replacement surgery.
Mitral Valve Area by Pressure Half-time Index	1.5 cm^2/m^2 Standard Deviation 0.6	1.7 cm^2/m^2 Standard Deviation 0.7

SECONDARY outcome

Timeframe: 24 months

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=123 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=54 Participants Mitral valve repair or replacement surgery.
Mitral Valve Area by Pressure Half-time Index	1.4 cm^2/m^2 Standard Deviation 0.4	1.5 cm^2/m^2 Standard Deviation 0.5

SECONDARY outcome

Timeframe: At Discharge (≤ 14 days following index procedure)

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=168 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=73 Participants Mitral valve repair or replacement surgery.
Transvalvular Mitral Valve Gradient	3.3 mmHg Standard Deviation 1.9	3.1 mmHg Standard Deviation 1.6

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=140 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=64 Participants Mitral valve repair or replacement surgery.
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)	3.2 mmHg Standard Deviation 1.7	3.1 mmHg Standard Deviation 1.2

SECONDARY outcome

Timeframe: 24 months

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=121 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=53 Participants Mitral valve repair or replacement surgery.
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)	2.8 mmHg Standard Deviation 1.4	2.9 mmHg Standard Deviation 1.8

SECONDARY outcome

Timeframe: 3 year

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=120 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=48 Participants Mitral valve repair or replacement surgery.
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)	3.0 mmHg Standard Deviation 1.5	2.8 mmHg Standard Deviation 1.4

SECONDARY outcome

Timeframe: 4 year

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=102 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=48 Participants Mitral valve repair or replacement surgery.
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)	3.0 mmHg Standard Deviation 1.4	3.1 mmHg Standard Deviation 1.5

SECONDARY outcome

Timeframe: 5 years

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=104 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=41 Participants Mitral valve repair or replacement surgery.
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)	3.0 mmHg Standard Deviation 1.4	3.0 mmHg Standard Deviation 1.4

SECONDARY outcome

Timeframe: 30 Days

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=178 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=80 Participants Mitral valve repair or replacement surgery.
Post-procedure Length of Hospital Stay	2.6 days Standard Deviation 6.3	7.5 days Standard Deviation 4

SECONDARY outcome

Timeframe: 30 Days

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=176 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=77 Participants Mitral valve repair or replacement surgery.
Post-procedure Intensive Care Unit (ICU) / Critical Care Unit (CCU) Duration	38.6 hours Standard Deviation 135.9	82.3 hours Standard Deviation 84.9

SECONDARY outcome

Timeframe: 30 days

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=171 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=76 Participants Mitral valve repair or replacement surgery.
Number of Participants With Hospital Re-admissions	24 Participants	14 Participants

SECONDARY outcome

Timeframe: 30 Days

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=178 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=80 Participants Mitral valve repair or replacement surgery.
Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility/Hospital	6 Participants	12 Participants

SECONDARY outcome

Timeframe: 30 days

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=171 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=76 Participants Mitral valve repair or replacement surgery.
Number of Participants With Incidence of Hospital Readmissions for Congestive Heart Failure (CHF).	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 30 days

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=143 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=65 Participants Mitral valve repair or replacement surgery.
Number of Participants With New Coumadin (Warfarin) Usage	13 Participants	29 Participants

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=143 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=65 Participants Mitral valve repair or replacement surgery.
Number of Participants With New Coumadin (Warfarin) Usage	36 Participants	33 Participants

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=137 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=80 Participants Mitral valve repair or replacement surgery.
Number of Participants With Durability of the MitraClip Device and Surgery. Deaths	6 Participants	5 Participants
Number of Participants With Durability of the MitraClip Device and Surgery. Surgeries	9 Participants	2 Participants
Number of Participants With Durability of the MitraClip Device and Surgery. Patients with MR > 2+	22 Participants	2 Participants
Number of Participants With Durability of the MitraClip Device and Surgery. Withdrawn/ Censored	3 Participants	6 Participants

SECONDARY outcome

Timeframe: 12-18 months

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=97 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=65 Participants Mitral valve repair or replacement surgery.
Number of Participants With Durability of the MitraClip Device and Surgery. Deaths	0 Participants	0 Participants
Number of Participants With Durability of the MitraClip Device and Surgery. Surgeries	0 Participants	1 Participants
Number of Participants With Durability of the MitraClip Device and Surgery. Patients with MR > 2+	4 Participants	2 Participants
Number of Participants With Durability of the MitraClip Device and Surgery. Withdrawn/ Censored	29 Participants	25 Participants

SECONDARY outcome

Timeframe: 18-24 months

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=64 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=37 Participants Mitral valve repair or replacement surgery.
Number of Participants With Durability of the MitraClip Device and Surgery. Deaths	0 Participants	0 Participants
Number of Participants With Durability of the MitraClip Device and Surgery. Surgeries	0 Participants	0 Participants
Number of Participants With Durability of the MitraClip Device and Surgery. Patients with MR > 2+	3 Participants	0 Participants
Number of Participants With Durability of the MitraClip Device and Surgery. Withdrawn/ Censored	19 Participants	12 Participants

SECONDARY outcome

Timeframe: 24 months-3 year

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=87 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=55 Participants Mitral valve repair or replacement surgery.
Number of Participants With Durability of the MitraClip Device and Surgery. Deaths	0 Participants	2 Participants
Number of Participants With Durability of the MitraClip Device and Surgery. Surgeries	0 Participants	1 Participants
Number of Participants With Durability of the MitraClip Device and Surgery. Patients with MR > 2+	4 Participants	0 Participants
Number of Participants With Durability of the MitraClip Device and Surgery. Withdrawn/ Censored	52 Participants	32 Participants

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=178 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=80 Participants Mitral valve repair or replacement surgery.
Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+	110 Participants	71 Participants

SECONDARY outcome

Timeframe: 24 months

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=178 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=80 Participants Mitral valve repair or replacement surgery.
Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+	101 Participants	66 Participants

SECONDARY outcome

Timeframe: 3 years

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=178 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=80 Participants Mitral valve repair or replacement surgery.
Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+	96 Participants	62 Participants

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=178 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=80 Participants Mitral valve repair or replacement surgery.
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation	141 Participants	78 Participants

SECONDARY outcome

Timeframe: 24 months

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=178 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=80 Participants Mitral valve repair or replacement surgery.
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation	140 Participants	77 Participants

SECONDARY outcome

Timeframe: 3 years

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=178 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=80 Participants Mitral valve repair or replacement surgery.
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation	139 Participants	76 Participants

SECONDARY outcome

Timeframe: 4 years

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=178 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=80 Participants Mitral valve repair or replacement surgery.
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation	137 Participants	76 Participants

SECONDARY outcome

Timeframe: 5 years

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=178 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=80 Participants Mitral valve repair or replacement surgery.
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation	135 Participants	75 Participants

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=178 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=80 Participants Mitral valve repair or replacement surgery.
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation	133 Participants	73 Participants

SECONDARY outcome

Timeframe: 24 months

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=178 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=80 Participants Mitral valve repair or replacement surgery.
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation	127 Participants	70 Participants

SECONDARY outcome

Timeframe: 3 years

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=178 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=80 Participants Mitral valve repair or replacement surgery.
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation	122 Participants	66 Participants

SECONDARY outcome

Timeframe: 4 years

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=178 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=80 Participants Mitral valve repair or replacement surgery.
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation	116 Participants	64 Participants

SECONDARY outcome

Timeframe: 5 years

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=178 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=80 Participants Mitral valve repair or replacement surgery.
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation	111 Participants	61 Participants

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=158 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) Mitral valve repair or replacement surgery.
Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment Device Embolization	0 Participants	—
Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment Single Leaflet Device Attachment	10 Participants	—

SECONDARY outcome

Timeframe: 12 months to 3 years

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=158 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) Mitral valve repair or replacement surgery.
Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment Device Embolization	0 Participants	—
Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment Single Leaflet Device Attachment	0 Participants	—

SECONDARY outcome

Timeframe: 12 months to 4 years

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=158 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) Mitral valve repair or replacement surgery.
Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment Device Embolization	0 Participants	—
Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment Single Leaflet Device Attachment	0 Participants	—

SECONDARY outcome

Timeframe: 12 months to 5 years

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=158 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) Mitral valve repair or replacement surgery.
Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment Device Embolization	0 Participants	—
Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment Single Leaflet Device Attachment	0 Participants	—

SECONDARY outcome

Timeframe: 12 months

Population: ITT population.

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=184 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=95 Participants Mitral valve repair or replacement surgery.
Number of Participants With Non-cerebral Thromboembolism.	3 Participants	3 Participants

SECONDARY outcome

Timeframe: 30 days

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=173 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=76 Participants Mitral valve repair or replacement surgery.
Number of Participants With MR Severity 0: None	2 Participants	16 Participants
Number of Participants With MR Severity 1+:Mild	89 Participants	48 Participants
Number of Participants With MR Severity 2+: Moderate	54 Participants	12 Participants
Number of Participants With MR Severity 3+: Moderate-to-Severe	19 Participants	0 Participants
Number of Participants With MR Severity 4+: Severe	9 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=149 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=66 Participants Mitral valve repair or replacement surgery.
Number of Participants With MR Severity 0: None	9 Participants	13 Participants
Number of Participants With MR Severity 1+:Mild	55 Participants	38 Participants
Number of Participants With MR Severity 2+: Moderate	57 Participants	14 Participants
Number of Participants With MR Severity 3+: Moderate-to-Severe	21 Participants	1 Participants
Number of Participants With MR Severity 4+: Severe	7 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 months

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=127 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=57 Participants Mitral valve repair or replacement surgery.
Number of Participants With MR Severity 0: None	2 Participants	3 Participants
Number of Participants With MR Severity 1+: Mild	44 Participants	45 Participants
Number of Participants With MR Severity 2+: Moderate	62 Participants	7 Participants
Number of Participants With MR Severity 3+: Moderate-to-Severe	15 Participants	1 Participants
Number of Participants With MR Severity 4+: Severe	4 Participants	1 Participants

SECONDARY outcome

Timeframe: 3 years

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=122 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=50 Participants Mitral valve repair or replacement surgery.
Number of Participants With MR Severity 0: None	3 Participants	7 Participants
Number of Participants With MR Severity 1+:Mild	45 Participants	36 Participants
Number of Participants With MR Severity 2+: Moderate	55 Participants	5 Participants
Number of Participants With MR Severity 3+: Moderate-to-Severe	19 Participants	2 Participants
Number of Participants With MR Severity 4+: Severe	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 4 years

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=105 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=49 Participants Mitral valve repair or replacement surgery.
Number of Participants With MR Severity 1+:Mild	41 Participants	38 Participants
Number of Participants With MR Severity 0: None	4 Participants	4 Participants
Number of Participants With MR Severity 2+: Moderate	40 Participants	4 Participants
Number of Participants With MR Severity 3+: Moderate-to-Severe	20 Participants	3 Participants
Number of Participants With MR Severity 4+: Severe	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 5 years

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

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=106 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=41 Participants Mitral valve repair or replacement surgery.
Number of Participants With MR Severity 0: None	4 Participants	6 Participants
Number of Participants With MR Severity 1+:Mild	49 Participants	32 Participants
Number of Participants With MR Severity 2+: Moderate	34 Participants	2 Participants
Number of Participants With MR Severity 3+: Moderate-to-Severe	18 Participants	1 Participants
Number of Participants With MR Severity 4+: Severe	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Population: ITT population.

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=184 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=95 Participants Mitral valve repair or replacement surgery.
Number of Participants With Non-cerebral Thromboembolism.	1 Participants	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.

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=158 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=80 Participants Mitral valve repair or replacement surgery.
Number of Participants With Incidence of Mitral Valve Replacement	17 Participants	11 Participants

SECONDARY outcome

Timeframe: 24 months

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

Outcome measures

Outcome measures
Measure	Device Group (MitraClip Device) n=167 Participants Percutaneous mitral valve repair using MitraClip implant.	Control Group (Mitral Valve Surgery) n=84 Participants Mitral valve repair or replacement surgery.
Number of Participants With Incidence of Mitral Valve Replacement	17 Participants	14 Participants

Adverse Events

Device Group (MitraClip Device)

Serious events: 127 serious events

Other events: 168 other events

Deaths: 20 deaths

Control Group (Mitral Valve Surgery)

Serious events: 54 serious events

Other events: 80 other events

Deaths: 9 deaths

Serious adverse events

Other adverse events

Additional Information

Chithra Sangli

Abbott Vascular Structural Heart (formerly Evalve, Inc.)

Phone: 650-421-6994

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60