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

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.

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.

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

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

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.

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.

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.

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.

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.

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.

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

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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

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

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.

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.

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.

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.

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.

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.

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.

• 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.

• 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.

• 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.

• 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.

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).

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).

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).

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.

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.

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.

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.

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

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.

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

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

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.

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.

Total patient population was enrolled from Australia. No patients were enrolled from New Zealand. The study recruitment rate was lower than anticipated.

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).

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).

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).

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

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.

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

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.

Procedure time was not available for 1 patient.

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.

Device time was not available for 1 patient.

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

Fluoroscopy duration was not available for 3 patient.

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

Total volume of contrast was not available for 5 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.

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.

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 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.

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-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.

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.

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.

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.

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

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).

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.