Trial Outcomes & Findings for MitraClip System in Australia and New Zealand (NCT NCT01301625)

NCT ID: NCT01301625

Last Updated: 2018-11-07

Results Overview

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).

• Recruitment status: TERMINATED
• Target enrollment: 78 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2018-11-07

Participant Flow

Seventy eight (78) patients who met trial enrollment criteria were enrolled at 6 investigational sites throughout Australia and New Zealand. Enrollment period was November 24, 2011 to June 15, 2014.

Participant milestones

Measure	MitraClip Implant Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Overall Study STARTED	78
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	35

Reasons for withdrawal

Measure	MitraClip Implant Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Overall Study Death	5
Overall Study Not Due	21
Overall Study Expected	8
Overall Study Lost to Follow-up	1

Baseline Characteristics

MitraClip System in Australia and New Zealand

Baseline characteristics by cohort

Measure	MitraClip Implant n=78 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Age, Continuous	77.1 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants
Region of Enrollment Australia	78 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	MitraClip Implant n=78 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)	0.0 percentage of participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	MitraClip Implant n=76 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)	0.0 percentage of participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	MitraClip Implant n=57 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)	6.1 percentage of participants

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	MitraClip Implant n=32 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)	8.3 percentage of participants

SECONDARY outcome

Timeframe: Day 0 (On the day of procedure)

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.

Outcome measures

Measure	MitraClip Implant n=78 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Number of Participants With 0, 1, 2, and 3 MitraClip Devices Implanted 0 Mitra Clip devices	1 Participants
Number of Participants With 0, 1, 2, and 3 MitraClip Devices Implanted 1 Mitra Clip devices	41 Participants
Number of Participants With 0, 1, 2, and 3 MitraClip Devices Implanted 2 Mitra Clip devices	35 Participants
Number of Participants With 0, 1, 2, and 3 MitraClip Devices Implanted 3 Mitra Clip devices	1 Participants

SECONDARY outcome

Timeframe: At day 0 (on the day of index procedure)

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

Outcome measures

Measure	MitraClip Implant n=78 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Acute Procedural Success Rate	39 Participants

SECONDARY outcome

Timeframe: At day 0 (on the day of index procedure)

Population: Procedure time was not available for 1 patient.

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.

Outcome measures

Measure	MitraClip Implant n=77 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Procedure Time	133.5 Minutes Standard Deviation 64.6

SECONDARY outcome

Timeframe: At day 0 (on the day of index procedure)

Population: Device 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.

Outcome measures

Measure	MitraClip Implant n=77 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Device Time	91.2 Minutes Standard Deviation 59.4

SECONDARY outcome

Timeframe: At day 0 (on the day of index procedure)

Population: Fluoroscopy duration was not available for 3 patient.

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

Outcome measures

Measure	MitraClip Implant n=75 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Fluoroscopy Duration	41.2 Minutes Standard Deviation 30.0

SECONDARY outcome

Timeframe: At day 0 (on the day of index procedure)

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

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

Outcome measures

Measure	MitraClip Implant n=73 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Total Contrast Volume	10.6 Milliliters Standard Deviation 29.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=65 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Left Ventricle End Diastolic Volume (LVEDV) Baseline	158.2 Milliliters Standard Deviation 68.4
Left Ventricle End Diastolic Volume (LVEDV) Discharge	151.3 Milliliters Standard Deviation 71.3

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	MitraClip Implant n=61 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Left Ventricle End Diastolic Volume (LVEDV) Baseline	152.9 ml Standard Deviation 67.8
Left Ventricle End Diastolic Volume (LVEDV) 30 Days	148.2 ml Standard Deviation 72.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=37 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Left Ventricle End Diastolic Volume (LVEDV) Baseline	161.1 ml Standard Deviation 75.7
Left Ventricle End Diastolic Volume (LVEDV) 12 Months	150.1 ml Standard Deviation 79.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=65 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Left Ventricular End Systolic Volume (LVESV) Baseline	93.3 Milliliter Standard Deviation 62.8
Left Ventricular End Systolic Volume (LVESV) Discharge	93.2 Milliliter Standard Deviation 63.3

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	MitraClip Implant n=61 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Left Ventricular End Systolic Volume (LVESV) Baseline	88.5 ml Standard Deviation 61.2
Left Ventricular End Systolic Volume (LVESV) 30 Days	89.0 ml Standard Deviation 61.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=37 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Left Ventricular End Systolic Volume (LVESV) Baseline	97.8 ml Standard Deviation 70.4
Left Ventricular End Systolic Volume (LVESV) 12 Months	91.7 ml Standard Deviation 73.1

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	MitraClip Implant n=73 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Left Ventricular Ejection Fraction (LVEF) Baseline	47.2 percent Standard Deviation 16.7
Left Ventricular Ejection Fraction (LVEF) Discharge	44.6 percent Standard Deviation 16.3

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	MitraClip Implant n=67 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Left Ventricular Ejection Fraction (LVEF) Baseline	48.4 percent Standard Deviation 16.3
Left Ventricular Ejection Fraction (LVEF) 30 Days	46.5 percent Standard Deviation 16.0

SECONDARY outcome

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

Outcome measures

Measure	MitraClip Implant n=40 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Left Ventricular Ejection Fraction (LVEF) Baseline	46.9 percent Standard Deviation 16.9
Left Ventricular Ejection Fraction (LVEF) 12 Months	47.4 percent Standard Deviation 18.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=77 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Number of Participants With MR Severity 3+: Moderate-to-Severe	22 Participants
Number of Participants With MR Severity 0: None	0 Participants
Number of Participants With MR Severity 1+:Mild	0 Participants
Number of Participants With MR Severity 2+: Moderate	0 Participants
Number of Participants With MR Severity 4+: Severe	55 Participants
Number of Participants With MR Severity Not Evaluable	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=74 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Number of Participants With MR Severity 0: None	1 Participants
Number of Participants With MR Severity 1+:Mild	38 Participants
Number of Participants With MR Severity 2+: Moderate	22 Participants
Number of Participants With MR Severity 3+: Moderate-to-Severe	9 Participants
Number of Participants With MR Severity 4+: Severe	3 Participants
Number of Participants With MR Severity Not Evaluable	1 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	MitraClip Implant n=69 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Number of Participants With MR Severity 0: None	1 Participants
Number of Participants With MR Severity 1+:Mild	26 Participants
Number of Participants With MR Severity 2+: Moderate	25 Participants
Number of Participants With MR Severity 3+: Moderate-to-Severe	12 Participants
Number of Participants With MR Severity 4+: Severe	5 Participants
Number of Participants With MR Severity Not Evaluable	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=60 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Number of Participants With MR Severity 0: None	0 Participants
Number of Participants With MR Severity 1+:Mild	20 Participants
Number of Participants With MR Severity 2+: Moderate	24 Participants
Number of Participants With MR Severity 3+: Moderate-to-Severe	12 Participants
Number of Participants With MR Severity 4+: Severe	4 Participants
Number of Participants With MR Severity Not Evaluable	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=42 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Number of Participants With MR Severity 0: None	2 Participants
Number of Participants With MR Severity 1+:Mild	15 Participants
Number of Participants With MR Severity 2+: Moderate	15 Participants
Number of Participants With MR Severity 3+: Moderate-to-Severe	7 Participants
Number of Participants With MR Severity 4+: Severe	3 Participants
Number of Participants With MR Severity Not Evaluable	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=72 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Left Ventricular Internal Diameter End Diastole (LVIDd) Baseline	5.9 cm Standard Deviation 1.0
Left Ventricular Internal Diameter End Diastole (LVIDd) Discharge	5.7 cm Standard Deviation 1.1

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	MitraClip Implant n=67 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Left Ventricular Internal Diameter End Diastole (LVIDd) Baseline	5.9 cm Standard Deviation 1.0
Left Ventricular Internal Diameter End Diastole (LVIDd) 30 Days	5.7 cm Standard Deviation 1.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=40 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Left Ventricular Internal Diameter End Diastole (LVIDd) Baseline	6.0 cm Standard Deviation 1.0
Left Ventricular Internal Diameter End Diastole (LVIDd) 12 Months	5.7 cm Standard Deviation 1.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=71 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Left Ventricular Internal Diameter End Systole (LVIDs) Baseline	4.5 cm Standard Deviation 1.4
Left Ventricular Internal Diameter End Systole (LVIDs) Discharge	4.4 cm Standard Deviation 1.4

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	MitraClip Implant n=61 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Left Ventricular Internal Diameter End Systole (LVIDs) Baseline	4.5 cm Standard Deviation 1.3
Left Ventricular Internal Diameter End Systole (LVIDs) 30 Days	4.5 cm Standard Deviation 1.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=36 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Left Ventricular Internal Diameter End Systole (LVIDs) Baseline	4.6 cm Standard Deviation 1.4
Left Ventricular Internal Diameter End Systole (LVIDs) 12 Months	4.5 cm Standard Deviation 1.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=45 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Regurgitant Volume Baseline	55.5 ml Standard Deviation 31.2
Regurgitant Volume Discharge	25.1 ml Standard Deviation 21.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=36 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Regurgitant Volume Baseline	61.9 ml Standard Deviation 42.8
Regurgitant Volume 30 Days	25.6 ml Standard Deviation 28.5

SECONDARY outcome

Timeframe: 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.

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

Measure	MitraClip Implant n=20 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Regurgitant Volume Baseline	49.8 ml Standard Deviation 29.0
Regurgitant Volume 12 Months	73.3 ml Standard Deviation 111.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=18 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Regurgitant Fraction Baseline	38.9 Percentage Standard Deviation 19.3
Regurgitant Fraction Discharge	25.8 Percentage Standard Deviation 36.5

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	MitraClip Implant n=16 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Regurgitant Fraction Baseline	40.5 Percentage Standard Deviation 19.7
Regurgitant Fraction 30 Days	15.2 Percentage Standard Deviation 41.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=5 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Regurgitant Fraction Baseline	44.6 Percentage Standard Deviation 15.9
Regurgitant Fraction 12 Months	36.8 Percentage Standard Deviation 18.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	MitraClip Implant n=54 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Area (MVA) by Pressure Half-time (PHT) Baseline	3.5 cm^2 Standard Deviation 1.2
Mitral Valve Area (MVA) by Pressure Half-time (PHT) Discharge	2.4 cm^2 Standard Deviation 0.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=50 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Area (MVA) by Pressure Half-time (PHT) Baseline	3.5 cm^2 Standard Deviation 1.0
Mitral Valve Area (MVA) by Pressure Half-time (PHT) 30 Days	2.3 cm^2 Standard Deviation 0.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=29 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Area (MVA) by Pressure Half-time (PHT) Baseline	3.8 cm^2 Standard Deviation 1.4
Mitral Valve Area (MVA) by Pressure Half-time (PHT) 12 Months	2.3 cm^2 Standard Deviation 0.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=65 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Mean Gradient Baseline	2.3 mmHg Standard Deviation 1.0
Mitral Valve Mean Gradient Discharge	3.7 mmHg Standard Deviation 1.6

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	MitraClip Implant n=59 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Mean Gradient Baseline	2.3 mmHg Standard Deviation 1.0
Mitral Valve Mean Gradient 30 Days	3.5 mmHg Standard Deviation 1.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=34 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Mitral Valve Mean Gradient Baseline	2.3 mmHg Standard Deviation 1.0
Mitral Valve Mean Gradient 12 Months	3.4 mmHg Standard Deviation 1.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=67 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Left Atrial Volume Baseline	141.7 ml Standard Deviation 54.7
Left Atrial Volume Discharge	141.8 ml Standard Deviation 62.9

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	MitraClip Implant n=62 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Left Atrial Volume Baseline	140.4 ml Standard Deviation 54.3
Left Atrial Volume 30 Days	138.8 ml Standard Deviation 58.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=39 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Left Atrial Volume Baseline	148.5 ml Standard Deviation 59.0
Left Atrial Volume 12 Months	132.4 ml Standard Deviation 64.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=76 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Six Minute Walking Distance	271.0 Meters Standard Deviation 119.4

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	MitraClip Implant n=68 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Six Minute Walking Distance	297.3 Meters Standard Deviation 130.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=60 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Six Minute Walking Distance	324.3 Meters Standard Deviation 139.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=39 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Six Minute Walking Distance	329.9 Meters Standard Deviation 120.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=78 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Percentage of Participants With New York Heart Association (NYHA) Class NYHA I	2.6 percentage of participants
Percentage of Participants With New York Heart Association (NYHA) Class NYHA II	26.9 percentage of participants
Percentage of Participants With New York Heart Association (NYHA) Class NYHA III	51.3 percentage of participants
Percentage of Participants With New York Heart Association (NYHA) Class NYHA IV	19.2 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=69 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Percentage of Participants With New York Heart Association (NYHA) Class NYHA I	36.2 percentage of participants
Percentage of Participants With New York Heart Association (NYHA) Class NYHA II	44.9 percentage of participants
Percentage of Participants With New York Heart Association (NYHA) Class NYHA III	15.9 percentage of participants
Percentage of Participants With New York Heart Association (NYHA) Class NYHA IV	2.9 percentage of participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	MitraClip Implant n=60 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Percentage of Participants With New York Heart Association (NYHA) Class NYHA II	56.7 percentage of participants
Percentage of Participants With New York Heart Association (NYHA) Class NYHA I	33.3 percentage of participants
Percentage of Participants With New York Heart Association (NYHA) Class NYHA III	8.3 percentage of participants
Percentage of Participants With New York Heart Association (NYHA) Class NYHA IV	1.7 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=40 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Percentage of Participants With New York Heart Association (NYHA) Class NYHA I	52.5 percentage of participants
Percentage of Participants With New York Heart Association (NYHA) Class NYHA II	42.5 percentage of participants
Percentage of Participants With New York Heart Association (NYHA) Class NYHA III	2.5 percentage of participants
Percentage of Participants With New York Heart Association (NYHA) Class NYHA IV	2.5 percentage of participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	MitraClip Implant n=70 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 30 Days Baseline	50.4 scores on a scale Standard Deviation 23.2
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 30 Days 30 days	26.4 scores on a scale Standard Deviation 20.1
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 30 Days Difference (30 days - Baseline)	-24.0 scores on a scale Standard Deviation 21.6

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	MitraClip Implant n=61 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 6 Months Baseline	49.5 scores on a scale Standard Deviation 23.5
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 6 Months 6 months	28.0 scores on a scale Standard Deviation 21.3
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 6 Months Difference (6 months - Baseline)	-21.5 scores on a scale Standard Deviation 22.5

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	MitraClip Implant n=40 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 12 Months Baseline	51.1 scores on a scale Standard Deviation 25.1
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 12 Months 12 months	30.2 scores on a scale Standard Deviation 22.7
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 12 Months Difference (12 months - Baseline)	-20.9 scores on a scale Standard Deviation 25.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=78 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)	100 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=73 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)	96.1 percentage of participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	MitraClip Implant n=55 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)	91.5 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	MitraClip Implant n=31 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)	85.3 percentage of participants

SECONDARY outcome

Timeframe: 30 days of Post-MitraClip Procedure

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

Outcome measures

Measure	MitraClip Implant n=78 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Mitral Valve Surgery Recurring mitral regurgitation	1 Participants
Number of Participants With Mitral Valve Surgery Device failure	1 Participants

SECONDARY outcome

Timeframe: Through 12 months

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.

Outcome measures

Measure	MitraClip Implant n=78 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Number of Participants With Second Intervention to Place an Additional MitraClip Device Recurring mitral regurgitation	2 Participants
Number of Participants With Second Intervention to Place an Additional MitraClip Device Single leaflet device attachment (SLDA)	1 Participants

SECONDARY outcome

Timeframe: 30 days

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

Outcome measures

Measure	MitraClip Implant n=78 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Rate of Patients Rehospitalized All re-hospitalizations	35 Participants
Rate of Patients Rehospitalized Heart Failure-related re-hospitalizations	10 Participants
Rate of Patients Rehospitalized Other cardiac-related re-hospitalizations	11 Participants
Rate of Patients Rehospitalized Other non-cardiac-related re-hospitalizations	22 Participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	MitraClip Implant n=78 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Duration of Rehospitalization All re-hospitalizations	8.4 Days Standard Deviation 12.9
Duration of Rehospitalization Heart Failure-related re-hospitalizations	18.38 Days Standard Deviation 20.65
Duration of Rehospitalization Other cardiac-related re-hospitalizations	2.87 Days Standard Deviation 5.03
Duration of Rehospitalization Other non-cardiac-related re-hospitalizations	7.44 Days Standard Deviation 9.01

SECONDARY outcome

Timeframe: < or = 12 days

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

Outcome measures

Measure	MitraClip Implant n=78 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Number of Participants at Discharge Facility Home	70 Participants
Number of Participants at Discharge Facility Home with home health care	4 Participants
Number of Participants at Discharge Facility Skilled nursing facility	1 Participants
Number of Participants at Discharge Facility Nursing home	0 Participants
Number of Participants at Discharge Facility Death	2 Participants
Number of Participants at Discharge Facility Other	1 Participants

SECONDARY outcome

Timeframe: Post index procedure within 30 days

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

Outcome measures

Measure	MitraClip Implant n=74 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Post-procedure Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-anesthesia Care Unit (PACU) Duration	62.1 Hours Standard Deviation 85.7

SECONDARY outcome

Timeframe: Post index procedure within 30 days

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

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.

Outcome measures

Measure	MitraClip Implant n=75 Participants Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Post-procedure Hospital Stay	3.4 Days Standard Deviation 2.2

Adverse Events

MitraClip Implant

Serious events: 37 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Measure	MitraClip Implant n=78 participants at risk Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Cardiac disorders Angina/Chest Pain	2.6% 2/78 • Number of events 2 • 1 year
Cardiac disorders Arrhythmias	7.7% 6/78 • Number of events 12 • 1 year
Vascular disorders Bleeding	6.4% 5/78 • Number of events 6 • 1 year
General disorders Fever or Hyperthermia	1.3% 1/78 • Number of events 1 • 1 year
Blood and lymphatic system disorders Hematoma	2.6% 2/78 • Number of events 2 • 1 year
Vascular disorders Hypotension/Hypertension	5.1% 4/78 • Number of events 4 • 1 year
Injury, poisoning and procedural complications Mitral Valve/Leaflet Injury	2.6% 2/78 • Number of events 2 • 1 year
General disorders Other	32.1% 25/78 • Number of events 38 • 1 year
Renal and urinary disorders Renal Insufficiency or Failure	6.4% 5/78 • Number of events 5 • 1 year
Respiratory, thoracic and mediastinal disorders Respiratory Failure/Atelectasis/Pneumonia	3.8% 3/78 • Number of events 4 • 1 year
Infections and infestations Septicemia	2.6% 2/78 • Number of events 3 • 1 year
Respiratory, thoracic and mediastinal disorders Shortness of Breath	3.8% 3/78 • Number of events 3 • 1 year
Cardiac disorders Stroke	3.8% 3/78 • Number of events 3 • 1 year
Renal and urinary disorders Urinary Tract Infection	1.3% 1/78 • Number of events 1 • 1 year

Other adverse events

Measure	MitraClip Implant n=78 participants at risk Eligible patients undergoing a MitraClip procedure in Australia and New Zealand MitraClip Implant: Percutaneous mitral valve repair using MitraClip implant.
Cardiac disorders Angina/Chest Pain	6.4% 5/78 • Number of events 7 • 1 year
Cardiac disorders Arrhythmias	12.8% 10/78 • Number of events 19 • 1 year
Vascular disorders Bleeding	30.8% 24/78 • Number of events 35 • 1 year
Blood and lymphatic system disorders Coagulopathy	1.3% 1/78 • Number of events 1 • 1 year
General disorders Fever or Hyperthermia	3.8% 3/78 • Number of events 3 • 1 year
Vascular disorders Hematoma	24.4% 19/78 • Number of events 28 • 1 year
Vascular disorders Hypotension/Hypertension	10.3% 8/78 • Number of events 9 • 1 year
Infections and infestations Infection at Access Site	1.3% 1/78 • Number of events 1 • 1 year
Infections and infestations Mitral Valve/Leaflet Injury	3.8% 3/78 • Number of events 3 • 1 year
General disorders Nausea/Vomiting	7.7% 6/78 • Number of events 7 • 1 year
General disorders Other	60.3% 47/78 • Number of events 136 • 1 year
General disorders Pain at Incision Site	5.1% 4/78 • Number of events 4 • 1 year
Renal and urinary disorders Renal Insufficiency or Failure	6.4% 5/78 • Number of events 5 • 1 year
Respiratory, thoracic and mediastinal disorders Respiratory Failure/Atelectasis/Pneumonia	7.7% 6/78 • Number of events 8 • 1 year
Infections and infestations Septicemia	2.6% 2/78 • Number of events 3 • 1 year
Respiratory, thoracic and mediastinal disorders Shortness of Breath	7.7% 6/78 • Number of events 6 • 1 year
Cardiac disorders Stroke	3.8% 3/78 • Number of events 3 • 1 year
Renal and urinary disorders Urinary Tract Infection	6.4% 5/78 • Number of events 6 • 1 year

Additional Information

Jeffrey T. Ellis

Abbott Vascular

Phone: (408) 845-8184

Email: jeffrey.ellis@av.abbott.com

Results disclosure agreements

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

Restriction type: LTE60