MitraClip System in Australia and New Zealand

Clinical Endpoint. * Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) * Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

Time frame: Baseline

Clinical Endpoint. * Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) * Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

Time frame: 30 days

Population: Two patient were lost to follow-up at the 30-day time point and were not included in the at risk population in the Kaplan-Meier freedom from mortality analysis.

Clinical Endpoint. * Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) * Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

Time frame: 6 months

Population: At the 6-month time point, 17 subjects had been censored and 4 had died, leaving 57 subjects at risk in the Kaplan-Meier freedom from mortality analysis at 6 months.

Clinical Endpoint. * Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) * Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

Time frame: 12 months

Population: A total of 32 patients were analyzed because 41 subjects had been censored and 5 had died at 12 months time frame.

The Minnesota Living with Heart Failure Questionnaire(MLHFQ) is comprised of 21 questions.The response for each question ranges from 0(no affect on the patient's living) to 5(affected the patient's life very much during the past month).The total score for the 21 items can range from 0-105.A lower&higher MLHFQ score indicates less effect of heart failure&the worse impact of heart failure on a patient's QOL,respectively.Although the MLHFQ incorporates relevant aspects of the key dimensions of QOL (physical and emotional),the questionnaire was not designed to measure any particular dimension separately.The total score should be taken as the best measure of how heart failure and treatments impact QOL. The total score is the sum of a)the physical dimension,measured using 8 questions (possible subscale score range 0-40) b)the emotional dimension,measured using 5 questions(possible subscale score from 0-25)&c) other factors,measured using 8 questions (possible subscale score from 0-40).

Time frame: 12 months

Population: Paired MLHFQ quality of life data was available for 40 patients at Baseline and 12 months.Five patients died prior to the 12-month visit,1 patient missed the 12-month visit,3 patients did not complete the MLHFQ assessment. Finally, 29 patients 12-month visits were either expected or not due at the time that the ANZ trial was terminated.

The Minnesota Living with Heart Failure Questionnaire(MLHFQ) is comprised of 21 questions.The response for each question ranges from 0(no affect on the patient's living) to 5(affected the patient's life very much during the past month).The total score for the 21 items can range from 0-105.A lower&higher MLHFQ score indicates less effect of heart failure&the worse impact of heart failure on a patient's QOL,respectively.Although the MLHFQ incorporates relevant aspects of the key dimensions of QOL (physical and emotional),the questionnaire was not designed to measure any particular dimension separately.The total score should be taken as the best measure of how heart failure and treatments impact QOL. The total score is the sum of a)the physical dimension,measured using 8 questions (possible subscale score range 0-40) b)the emotional dimension,measured using 5 questions(possible subscale score from 0-25)&c) other factors,measured using 8 questions (possible subscale score from 0-40).

Time frame: 30 days

Population: Paired Minnesota Living with Heart Failure Questionnaire (MLHFQ) quality of life data was available for 70 patients at Baseline and 30 days. Six patients missed their 30-day visit and 2 patients did not complete the MLHFQ at either baseline, 30 days, or both time points.

The Minnesota Living with Heart Failure Questionnaire(MLHFQ) is comprised of 21 questions.The response for each question ranges from 0(no affect on the patient's living) to 5(affected the patient's life very much during the past month).The total score for the 21 items can range from 0-105.A lower&higher MLHFQ score indicates less effect of heart failure&the worse impact of heart failure on a patient's QOL,respectively.Although the MLHFQ incorporates relevant aspects of the key dimensions of QOL (physical and emotional),the questionnaire was not designed to measure any particular dimension separately.The total score should be taken as the best measure of how heart failure and treatments impact QOL. The total score is the sum of a)the physical dimension,measured using 8 questions (possible subscale score range 0-40) b)the emotional dimension,measured using 5 questions(possible subscale score from 0-25)&c) other factors,measured using 8 questions (possible subscale score from 0-40).

Time frame: 6 months

Population: Paired Minnesota Living with Heart Failure Questionnaire (MLHFQ) quality of life data was available for 61 patients at Baseline and 6 months. Four patients died prior to the 6-month visit,1 patient missed the 6-month visit and 12 patients 6-month visits were either expected or not due at the time that the ANZ trial was terminated.

This is one of the Device and Procedure-Related Endpoints. Device Time is defined as the time the Steerable Guide Catheter is placed in the intra-atrial septum until the time the MitraClip Delivery System (CDS) is retracted into the Steerable Guide Catheter. Device Time is shorter in duration than Procedure Time because it does not include the time required to perform transseptal access into the left atrium.

Time frame: At day 0 (on the day of index procedure)

Population: Device time was not available for 1 patient.

Time frame: 30 days

This is one of the Device and Procedure-Related Endpoints. Mean fluoroscopy duration during the MitraClip procedure.

Time frame: At day 0 (on the day of index procedure)

Population: Fluoroscopy duration was not available for 3 patient.

Left atrial volume is assessed by echocardiography. Using the single plane method of disks, the left atrial volume is derived by planimetry in the 4-chamber view at end-systole.

Time frame: At Baseline and Discharge (≤7 days of index procedure)

Population: A total of 67 patients had paired left atrial (LA) volume measurements at both baseline and discharge. LA volume data at either baseline, discharge, or both time points are missing for 11 patients.

Left atrial volume is assessed by echocardiography. Using the single plane method of disks, the left atrial volume is derived by planimetry in the 4-chamber view at end-systole.

Time frame: At Baseline and 12 Months

Population: A total of 39 patients had paired LA volume measurements because 5 patients died prior to the 12-month visit, 1 patient missed the 12-month visit, 4 patients have missing LA volume data at either baseline, 12 months, or both time points and 29 patients 12-month visits were either expected or not due at the time that the ANZ trial was terminated.

Left atrial volume is assessed by echocardiography. Using the single plane method of disks, the left atrial volume is derived by planimetry in the 4-chamber view at end-systole.

Time frame: At Baseline and 30 Days

Population: A total of 62 patients had paired left atrial (LA) volume measurements at both baseline and 30 days. Six patients missed the 30-day visit, Where as LA volume data at either baseline, 30 days, or both time points are missing for 10 patients.

Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.

Time frame: At Baseline and 12 months

Population: A total of 41 patients were excluded from total analysis population as 5 patients died, 1 patient missed the 12-month visit, 6 patients had missing LVEDV at either baseline, the 12-month visit, or both time points, and finally 29 subjects 12-month visits were either expected or not due at the time that the ANZ trial was terminated.

Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.

Time frame: At Baseline and Discharge (≤7 days of index procedure)

Population: A total of 65 patients had paired left ventricular end diastolic volume (LVEDV) measurements at both baseline and discharge. Thirteen patients had missing LVEDV at either baseline, discharge, or both time points.

Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.

Time frame: At Baseline and 30 Days

Population: A total of 61 patients had paired left ventricular end diastolic volume (LVEDV) measurements at both baseline and 30 days. Six patients missed the 30-day visit and 11 patients had missing LVEDV at either baseline, the 30-day visit, or both time points.

Left ventricular ejection fraction is assessed by transthoracic echocardiography according to Simpson's rule (biplane method of disks).

Time frame: At Baseline and 30 Days

Population: A total of 67 patients had paired left ventricular ejection fraction (LVEF) measurements at both baseline and 30 days. Six patients missed the 30-day visit and 5 patients had missing LVEF at either baseline, the 30-day visit, or both time points.

Left ventricular ejection fraction is assessed by transthoracic echocardiography according to Simpson's rule (biplane method of disks).

Time frame: At Baseline and Discharge (≤7 days of index procedure)

Population: A total of 73 patients had paired left ventricular ejection fraction (LVEF) measurements at both baseline and discharge. Five patients had missing LVEF at either baseline, discharge, or both time points.

Left ventricular ejection fraction is assessed by transthoracic echocardiography according to Simpson's rule (biplane method of disks).

Time frame: At Baseline and 12 months

Population: A total of 40 patients included in analysis population because 5 patients died prior to the 12-month visit, 1 patient missed the 12-month visit, 3 patients had missing LVEF at either baseline, the 12-month visit, or both time points and 29 patients 12-month visits were either expected/not due at the time that the ANZ trial was terminated.

Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.

Time frame: At Baseline and Discharge (≤7 days of index procedure)

Population: A total of 65 patients had paired left ventricular end systolic volume (LVESV) measurements at both baseline and discharge. Thirteen patients had missing LVESV at either baseline, discharge, or both time points.

Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.

Time frame: At Baseline and 12 months

Population: Of total 78 subjects, 37 patients were analyzed because 5 patients died prior to the 12-month visit, 1 patient missed the 12-month visit, 6 patients had missing LVESV at either baseline, the 12-month visit, or both time points, and finally 29 patients 12-month visits were either expected or not due at the time that the ANZ trial was terminated.

Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.

Time frame: At Baseline and 30 Days

Population: A total of 61 patients had paired left ventricular end systolic volume (LVESV) measurements at both baseline and 30 days. Six patients missed the 30-day visit and 11 patients had missing LVESV at either baseline, the 30-day visit, or both time points.

LVIDd is the measurements of the left ventricular internal dimension at end-diastole and normally corresponds to the largest cardiac dimension. LVIDd is measured by transthoracic echocardiography and the results are interpreted by the study's echocardiography core laboratory.

Time frame: At Baseline and Discharge (≤7 days of index procedure)

Population: A total of 72 patients had paired left ventricular internal diameter in diastole (LVIDd) measurements at both baseline and discharge. Six patients had missing LVIDd at either baseline, discharge, or both time points.

LVIDd is the measurements of the left ventricular internal dimension at end-diastole and normally corresponds to the largest cardiac dimension. LVIDd is measured by transthoracic echocardiography and the results are interpreted by the study's echocardiography core laboratory.

Time frame: At Baseline and 12 Months

Population: A total of 40 patients were included in analysis because 5 patients died prior to the 12-month visit,1 patient missed the 12-month visit,3 patients had missing LVIDd at either baseline,the 12-month visit,or both time points \& 29 patients 12-month visits were either expected or not due at the time that the ANZ trial was terminated.

LVIDd is the measurements of the left ventricular internal dimension at end-diastole and normally corresponds to the largest cardiac dimension. LVIDd is measured by transthoracic echocardiography and the results are interpreted by the study's echocardiography core laboratory.

Time frame: At Baseline and 30 Days

Population: A total of 67 patients had paired left ventricular internal diameter in diastole (LVIDd) measurements at both baseline and 30 days. Six patients missed the 30-day visit and 5 patients had missing LVIDd at either baseline, the 30-day visit, or both time points.

LVIDs is the measurements of the left ventricular internal dimension at end-systole and normally corresponds to the smallest cardiac dimension. LVIDs is measured by transthoracic echocardiography and the results are interpreted by the study's echocardiography core laboratory.

Time frame: At Baseline and Discharge (≤7 days of index procedure)

Population: A total of 71 patients had paired left ventricular internal diameter in systole (LVIDs) measurements at both baseline and discharge. Seven patients had missing LVIDs at either baseline, discharge, or both time points.

LVIDs is the measurements of the left ventricular internal dimension at end-systole and normally corresponds to the smallest cardiac dimension. LVIDs is measured by transthoracic echocardiography and the results are interpreted by the study's echocardiography core laboratory.

Time frame: At Baseline and 12 Months

Population: A total of 36 patients had paired LVIDs measurements Because 5 patients died prior to the 12-month visit, 1 patient missed the 12-month visit, 7 patients had missing LVIDs at either baseline, the 12-month visit, or both time points and 29 patients 12-month visits were either expected or not due at the time that the ANZ trial was terminated.

LVIDs is the measurements of the left ventricular internal dimension at end-systole and normally corresponds to the smallest cardiac dimension. LVIDs is measured by transthoracic echocardiography and the results are interpreted by the study's echocardiography core laboratory.

Time frame: At Baseline and 30 Days

Population: A total of 61 patients had paired left ventricular internal diameter in systole (LVIDs) measurements at both baseline and 30 days. Six patients missed the 30-day visit and 11 patients had missing LVIDs at either baseline, the 30-day visit, or both time points.

Measure of the area of the mitral valve orifice using transthoracic echocardiography. The pressure half time method is used to assess the presence and severity of mitral stenosis. Results are interpreted by the study's echocardiography core laboratory.

Time frame: At Baseline and 30 Days

Population: A total of 50 patients had paired mitral valve area (MVA) by pressure half-time measurements at both baseline and 30 days. Six patients missed the 30-day visit. Where as, regurgitant fraction data at either baseline, 30 days, or both time points is missing for 22 patients.

Measure of the area of the mitral valve orifice using transthoracic echocardiography. The pressure half time method is used to assess the presence and severity of mitral stenosis. Results are interpreted by the study's echocardiography core laboratory.

Time frame: At Baseline and 12 Months

Population: A total of 29 patients were analyzed because 5 patients died prior to the 12-month visit,1 patient missed the 12-month visit, 14 patients have missing MVA data at either baseline, 12 months, or both time points. Finally 29 patients 12-month visits were either expected or not due at the time that the ANZ trial was terminated.

Measure of the area of the mitral valve orifice using transthoracic echocardiography. The pressure half time method is used to assess the presence and severity of mitral stenosis. Results are interpreted by the study's echocardiography core laboratory.

Time frame: At Baseline and Discharge (≤7 days of index procedure)

Population: A total of 54 patients had paired mitral valve area (MVA) by pressure half-time measurements at both baseline and discharge. MVA data at either baseline, discharge, or both time points is missing for 24 patients.

Mitral valve mean gradient is defined as the mean pressure gradients across the mitral valve as measured by echocardiography.

Time frame: At Baseline and 12 Months

Population: A total of 34 patients had paired MVG measurements because 5 patients died prior to the 12-month visit, 1 patient missed the 12-month visit, 9 patients have missing MVG data at either baseline, 12 months, or both time points. Finally 29 patients 12-month visits were either expected or not due at the time that the ANZ trial was terminated.

Mitral valve mean gradient is defined as the mean pressure gradients across the mitral valve as measured by echocardiography.

Time frame: At Baseline and Discharge (≤7 days of index procedure)

Population: A total of 65 patients had paired mitral valve mean gradient (MVG) measurements at both baseline and discharge. MVG data at either baseline, discharge, or both time points is missing for 13 patients.

Mitral valve mean gradient is defined as the mean pressure gradients across the mitral valve as measured by echocardiography.

Time frame: At Baseline and 30 Days

Population: A total of 59 patients had paired mitral valve mean gradient (MVG) measurements at both baseline and 30 days. Six patients missed the 30-day visit. MVG data at either baseline, 30 days, or both time points are missing for 13 patients.

This is the economic data reported to support the MitraClip System economic analysis.

Time frame: < or = 12 days

This is one of the Device and Procedure-Related Endpoints. Implant Rate is defined as the rate of successful delivery and deployment of MitraClip device implant(s) with echocardiographic evidence of leaflet approximation and retrieval of the delivery catheter.

Time frame: Day 0 (On the day of procedure)

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

Time frame: At day 0 (on the day of index procedure)

Mital Valve Surgery Post-MitraClip Procedure; Surgery Types includes Replacement and Repair.

Time frame: 30 days of Post-MitraClip Procedure

Mitral regurgitation severity was determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity was scored using the integrative method based on qualitative and quantitative echocardiographic parameters as described in the ASE guidelines.Site-assessed mitral regurgitation severity using echocardiography. MR severity was graded as follows: 0: None, 1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe.

Time frame: At discharge (≤7 days of index procedure)

Population: Mitral regurgitation severity is missing in 4 patient at Discharge.

Mitral regurgitation severity was determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity was scored using the integrative method based on qualitative and quantitative echocardiographic parameters as described in the ASE guidelines.Site-assessed mitral regurgitation severity using echocardiography. MR severity was graded as follows: 0: None, 1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe.

Time frame: 12 months

Population: Mitral regurgitation severity is available for 42 patients at 12 months. Five patients died prior the 12-month visit, 1 patient missed the 12-month visit, 1 patient had missing MR severity at 12 months, and finally 29 patients 12-month visits were either expected or not due at the time that the ANZ trial was terminated.

Mitral regurgitation severity was determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity was scored using the integrative method based on qualitative and quantitative echocardiographic parameters as described in the ASE guidelines.Site-assessed mitral regurgitation severity using echocardiography. MR severity was graded as follows: 0: None, 1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe.

Time frame: Baseline

Population: Mitral regurgitation severity is missing in 1 patient at Baseline.

Mitral regurgitation severity was determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity was scored using the integrative method based on qualitative and quantitative echocardiographic parameters as described in the ASE guidelines.Site-assessed mitral regurgitation severity using echocardiography. MR severity was graded as follows: 0: None, 1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe.

Time frame: 6 months

Population: Mitral regurgitation severity is available for 60 patients at 6 months. Four patients died prior the 6-month visit, 1 patient missed the 6-month visit, 1 patient had missing MR severity at 6 months, and finally 12 patients 6-month visits were either expected or not due at the time that the ANZ trial was terminated.

Mitral regurgitation severity was determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity was scored using the integrative method based on qualitative and quantitative echocardiographic parameters as described in the ASE guidelines.Site-assessed mitral regurgitation severity using echocardiography. MR severity was graded as follows: 0: None, 1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe.

Time frame: 30 days

Population: Mitral regurgitation severity is available for 69 patients at 30 days. Six patients missed the 30-day visit and 3 patients had not evaluated for MR severity at 30 days.

Second MitraClip device interventions are reported by Abbott Vascular personnel on Procedural Observation Forms. A second MitraClip device intervention is a good option for patients with MR following placement of the original MitraClip device.

Time frame: Through 12 months

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

Time frame: Baseline

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

Time frame: 30 days

Population: Two patient were lost to follow-up at the 30-day time point and 1 had been censored at Baseline. Therefore, 73 patients were included in the at risk population in the Kaplan-Meier freedom from death and congestive heart failure analysis at 30 days.

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

Time frame: 12 months

Population: At 12 months, 31 patients were considered at risk because 38 had been censored and 9 patients experienced an event (i.e. death or CHF event).

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

Time frame: 6 months

Population: At 6 months, 55 patients were considered at risk because 17 had been censored, and 6 patients experienced an event (i.e. death or CHF event).

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

Time frame: 12 months

Population: NYHA functional class assessment is available for 40 patients at 12 months.Five patients died prior to the 12-month visit,1 patient missed the 12-month visit, 3 patients did not have a NYHA functional class assessment and finally 29 patients 12-month visits were either expected or not due at the time that the ANZ trial was terminated.

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

Time frame: Baseline

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

Time frame: 30 days

Population: A total of 69 patients were included in analysis population because 6 patients had lost-to-follow up at 30 days and 3 patients did not have a NYHA functional class assessment.

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

Time frame: 6 months

Population: NYHA functional class assessment is available for 60 patients at 6 months. Four patients died prior to the 6-month visit, 1 patient missed the 6-month visit, 1 patient did not have a NYHA functional class assessment at 6-months, and finally 12 patients 6-month visits were either expected or not due at the time that the ANZ trial was terminated.

This is the Economic data reported to support the MitraClip System economic analysis. It is defined as the mean duration of time that patients spent in hospital following the MitraClip procedure.

Time frame: Post index procedure within 30 days

Population: Duration of post-procedure hospital stay was not available for 3 patients.

ICU and hospital stay is defined as the mean duration of time that patients spent in the ICU (Intensive Care Unit)/ CCU (Cardiac Care Unit)/ PACU (Post-Anesthesia Care Unit) following the MitraClip procedure.

Time frame: Post index procedure within 30 days

Population: Post-Procedure ICU/CCU/PACU duration was not available for 4 patients.

This is one of the Device and Procedure-Related Endpoints. Procedure Time is defined as the time elapsed from the start of the transseptal procedure to the time the Steerable Guide Catheter is removed.

Time frame: At day 0 (on the day of index procedure)

Population: Procedure time was not available for 1 patient.

Defined as re-admission of patients to the hospital following discharge from the Clip procedure.

Time frame: 30 days

Regurgitant fraction as determined by the core echo laboratory. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.

Time frame: At Baseline and Discharge (≤7 days of index procedure)

Population: A total of 18 patients had paired regurgitant fraction measurements at both baseline and discharge. Regurgitant fraction data at either baseline, discharge, or both time points is missing for 60 patients.

Regurgitant fraction as determined by the core echo laboratory. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.

Time frame: At Baseline and 12 Months

Population: Few patients excluded from analysis population because 5 patients died prior to the 12-month visit,1 patient missed the 12-month visit, 38 patients have missing regurgitant fraction data at either baseline, 12 months, or both time points and 29 patients 12-month visits were either expected or not due at the time that the ANZ trial was terminated.

Regurgitant fraction as determined by the core echo laboratory. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.

Time frame: At Baseline and 30 Days

Population: A total of 16 patients had paired regurgitant fraction measurements at both baseline and 30 days. Six patients missed the 30-day visit. Whereas, regurgitant fraction data at either baseline, 30 days, or both time points is missing for 56 patients.

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

Time frame: At Baseline and Discharge (≤7 days of index procedure)

Population: A total of 45 patients had paired regurgitant volume measurements at both baseline and discharge. Regurgitant volume data at either baseline, discharge, or both time points is missing for 33 patients.

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

Time frame: At Baseline and 30 Days

Population: A total of 36 patients had paired regurgitant volume measurements at both baseline and 30 days. Six patients missed the 30-day visit and regurgitant volume data at either baseline, 30 days, or both time points is missing for 36 patients.

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

Time frame: At Baseline and 12 Months

Population: A total of 20 patients were included in analysis because 5 patients died prior to the 12-month visit, 1 patient missed the 12-month visit, 23 patients have missing regurgitant volume data at either baseline, 12 months, or both time points \& 29 patients 12-month visits were either expected or not due at the time that the ANZ trial was terminated.

The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. It is a measure of a patient's exercise capacity.

Time frame: Baseline

Population: Six-minuted walk test (6MWT) distance is available for 76 patients at baseline because 2 patients did not complete the 6MWT at baseline.

The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. It is a measure of a patient's exercise capacity.

Time frame: 12 months

Population: Six-minuted walk test (6MWT) distance is available for 39 patients at 12 months. Five patients died prior to the 12-month visit, 1 patient missed the 12-month visit, 4 patients did not complete the 6MWT at 12 months, and finally 29 patients 6-month visits were either expected or not due at the time that the ANZ trial was terminated.

The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. It is a measure of a patient's exercise capacity.

Time frame: 6 months

Population: Six-minuted walk test (6MWT) distance is available for 60 patients at 6 months. Four patients died prior to the 6-month visit, 1 patient missed the 6-month visit, 1 patient did not complete the 6MWT at 6-months, and finally, 12 patients 6-month visits were either expected or not due at the time that the ANZ trial was terminated.

The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. It is a measure of a patient's exercise capacity.

Time frame: 30 days

Population: Six-minuted walk test (6MWT) distance is available for 68 patients at 30 days. Six patients missed the 30-day visit and 4 patients did not complete the 6MWT at 30-days.

This is one of the Device and Procedure-Related Endpoints.

Time frame: At day 0 (on the day of index procedure)

Population: Total volume of contrast was not available for 5 patients.