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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01301625




Registration number
NCT01301625
Ethics application status
Date submitted
4/02/2011
Date registered
23/02/2011
Date last updated
7/11/2018

Titles & IDs
Public title
MitraClip System in Australia and New Zealand
Scientific title
A Prospective Single Arm Clinical Trial Evaluating the MitraClip System in Australia and New Zealand
Secondary ID [1] 0 0
Protocol #M10-001
Universal Trial Number (UTN)
Trial acronym
MitraClipANZ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mitral Regurgitation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - MitraClip Implant

MitraClip Implant - Eligible patients undergoing a MitraClip procedure in Australia and New Zealand


Treatment: Devices: MitraClip Implant
Percutaneous mitral valve repair using MitraClip implant.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Experiencing Death (Kaplan-Meier 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).
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
Percentage of Participants Experiencing Death (Kaplan-Meier 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).
Timepoint [2] 0 0
30 days
Primary outcome [3] 0 0
Percentage of Participants Experiencing Death (Kaplan-Meier 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).
Timepoint [3] 0 0
6 months
Primary outcome [4] 0 0
Percentage of Participants Experiencing Death (Kaplan-Meier 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).
Timepoint [4] 0 0
12 months
Secondary outcome [1] 0 0
Number of Participants With 0, 1, 2, and 3 MitraClip Devices Implanted - 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.
Timepoint [1] 0 0
Day 0 (On the day of procedure)
Secondary outcome [2] 0 0
Number of Participants With Acute Procedural Success Rate - Defined as successful MitraClip implantation with resulting MR of 2+ or less.
Timepoint [2] 0 0
At day 0 (on the day of index procedure)
Secondary outcome [3] 0 0
Procedure Time - 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.
Timepoint [3] 0 0
At day 0 (on the day of index procedure)
Secondary outcome [4] 0 0
Device Time - 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.
Timepoint [4] 0 0
At day 0 (on the day of index procedure)
Secondary outcome [5] 0 0
Fluoroscopy Duration - This is one of the Device and Procedure-Related Endpoints. Mean fluoroscopy duration during the MitraClip procedure.
Timepoint [5] 0 0
At day 0 (on the day of index procedure)
Secondary outcome [6] 0 0
Total Contrast Volume - This is one of the Device and Procedure-Related Endpoints.
Timepoint [6] 0 0
At day 0 (on the day of index procedure)
Secondary outcome [7] 0 0
Left Ventricle End Diastolic Volume (LVEDV) - 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.
Timepoint [7] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [8] 0 0
Left Ventricle End Diastolic Volume (LVEDV) - 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.
Timepoint [8] 0 0
At Baseline and 30 Days
Secondary outcome [9] 0 0
Left Ventricle End Diastolic Volume (LVEDV) - 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.
Timepoint [9] 0 0
At Baseline and 12 months
Secondary outcome [10] 0 0
Left Ventricular End Systolic Volume (LVESV) - 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.
Timepoint [10] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [11] 0 0
Left Ventricular End Systolic Volume (LVESV) - 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.
Timepoint [11] 0 0
At Baseline and 30 Days
Secondary outcome [12] 0 0
Left Ventricular End Systolic Volume (LVESV) - 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.
Timepoint [12] 0 0
At Baseline and 12 months
Secondary outcome [13] 0 0
Left Ventricular Ejection Fraction (LVEF) - Left ventricular ejection fraction is assessed by transthoracic echocardiography according to Simpson's rule (biplane method of disks).
Timepoint [13] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [14] 0 0
Left Ventricular Ejection Fraction (LVEF) - Left ventricular ejection fraction is assessed by transthoracic echocardiography according to Simpson's rule (biplane method of disks).
Timepoint [14] 0 0
At Baseline and 30 Days
Secondary outcome [15] 0 0
Left Ventricular Ejection Fraction (LVEF) - Left ventricular ejection fraction is assessed by transthoracic echocardiography according to Simpson's rule (biplane method of disks).
Timepoint [15] 0 0
At Baseline and 12 months
Secondary outcome [16] 0 0
Number of Participants With MR Severity - 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.
Timepoint [16] 0 0
Baseline
Secondary outcome [17] 0 0
Number of Participants With MR Severity - 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.
Timepoint [17] 0 0
At discharge (=7 days of index procedure)
Secondary outcome [18] 0 0
Number of Participants With MR Severity - 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.
Timepoint [18] 0 0
30 days
Secondary outcome [19] 0 0
Number of Participants With MR Severity - 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.
Timepoint [19] 0 0
6 months
Secondary outcome [20] 0 0
Number of Participants With MR Severity - 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.
Timepoint [20] 0 0
12 months
Secondary outcome [21] 0 0
Left Ventricular Internal Diameter End Diastole (LVIDd) - 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.
Timepoint [21] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [22] 0 0
Left Ventricular Internal Diameter End Diastole (LVIDd) - 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.
Timepoint [22] 0 0
At Baseline and 30 Days
Secondary outcome [23] 0 0
Left Ventricular Internal Diameter End Diastole (LVIDd) - 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.
Timepoint [23] 0 0
At Baseline and 12 Months
Secondary outcome [24] 0 0
Left Ventricular Internal Diameter End Systole (LVIDs) - 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.
Timepoint [24] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [25] 0 0
Left Ventricular Internal Diameter End Systole (LVIDs) - 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.
Timepoint [25] 0 0
At Baseline and 30 Days
Secondary outcome [26] 0 0
Left Ventricular Internal Diameter End Systole (LVIDs) - 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.
Timepoint [26] 0 0
At Baseline and 12 Months
Secondary outcome [27] 0 0
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.
Timepoint [27] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [28] 0 0
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.
Timepoint [28] 0 0
At Baseline and 30 Days
Secondary outcome [29] 0 0
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.
Timepoint [29] 0 0
At Baseline and 12 Months
Secondary outcome [30] 0 0
Regurgitant Fraction - 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.
Timepoint [30] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [31] 0 0
Regurgitant Fraction - 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.
Timepoint [31] 0 0
At Baseline and 30 Days
Secondary outcome [32] 0 0
Regurgitant Fraction - 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.
Timepoint [32] 0 0
At Baseline and 12 Months
Secondary outcome [33] 0 0
Mitral Valve Area (MVA) by Pressure Half-time (PHT) - 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.
Timepoint [33] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [34] 0 0
Mitral Valve Area (MVA) by Pressure Half-time (PHT) - 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.
Timepoint [34] 0 0
At Baseline and 30 Days
Secondary outcome [35] 0 0
Mitral Valve Area (MVA) by Pressure Half-time (PHT) - 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.
Timepoint [35] 0 0
At Baseline and 12 Months
Secondary outcome [36] 0 0
Mitral Valve Mean Gradient - Mitral valve mean gradient is defined as the mean pressure gradients across the mitral valve as measured by echocardiography.
Timepoint [36] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [37] 0 0
Mitral Valve Mean Gradient - Mitral valve mean gradient is defined as the mean pressure gradients across the mitral valve as measured by echocardiography.
Timepoint [37] 0 0
At Baseline and 30 Days
Secondary outcome [38] 0 0
Mitral Valve Mean Gradient - Mitral valve mean gradient is defined as the mean pressure gradients across the mitral valve as measured by echocardiography.
Timepoint [38] 0 0
At Baseline and 12 Months
Secondary outcome [39] 0 0
Left Atrial Volume - 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.
Timepoint [39] 0 0
At Baseline and Discharge (=7 days of index procedure)
Secondary outcome [40] 0 0
Left Atrial Volume - 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.
Timepoint [40] 0 0
At Baseline and 30 Days
Secondary outcome [41] 0 0
Left Atrial Volume - 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.
Timepoint [41] 0 0
At Baseline and 12 Months
Secondary outcome [42] 0 0
Six Minute Walking Distance - 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.
Timepoint [42] 0 0
Baseline
Secondary outcome [43] 0 0
Six Minute Walking Distance - 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.
Timepoint [43] 0 0
30 days
Secondary outcome [44] 0 0
Six Minute Walking Distance - 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.
Timepoint [44] 0 0
6 months
Secondary outcome [45] 0 0
Six Minute Walking Distance - 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.
Timepoint [45] 0 0
12 months
Secondary outcome [46] 0 0
Percentage of Participants With New York Heart Association (NYHA) Class - Class I Patients with cardiac disease but without resulting limitations of physical activity;
Class II Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain;
Class III Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain;
Class IV Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Timepoint [46] 0 0
Baseline
Secondary outcome [47] 0 0
Percentage of Participants With New York Heart Association (NYHA) Class - Class I Patients with cardiac disease but without resulting limitations of physical activity;
Class II Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain;
Class III Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain;
Class IV Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Timepoint [47] 0 0
30 days
Secondary outcome [48] 0 0
Percentage of Participants With New York Heart Association (NYHA) Class - Class I Patients with cardiac disease but without resulting limitations of physical activity;
Class II Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain;
Class III Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain;
Class IV Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Timepoint [48] 0 0
6 months
Secondary outcome [49] 0 0
Percentage of Participants With New York Heart Association (NYHA) Class - Class I Patients with cardiac disease but without resulting limitations of physical activity;
Class II Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain;
Class III Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain;
Class IV Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Timepoint [49] 0 0
12 months
Secondary outcome [50] 0 0
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 30 Days - 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).
Timepoint [50] 0 0
30 days
Secondary outcome [51] 0 0
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 6 Months - 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).
Timepoint [51] 0 0
6 months
Secondary outcome [52] 0 0
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 12 Months - 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).
Timepoint [52] 0 0
12 months
Secondary outcome [53] 0 0
Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis) - 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.
Timepoint [53] 0 0
Baseline
Secondary outcome [54] 0 0
Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis) - 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.
Timepoint [54] 0 0
30 days
Secondary outcome [55] 0 0
Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis) - 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.
Timepoint [55] 0 0
6 months
Secondary outcome [56] 0 0
Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis) - 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.
Timepoint [56] 0 0
12 months
Secondary outcome [57] 0 0
Number of Participants With Mitral Valve Surgery - Mital Valve Surgery Post-MitraClip Procedure; Surgery Types includes Replacement and Repair.
Timepoint [57] 0 0
30 days of Post-MitraClip Procedure
Secondary outcome [58] 0 0
Number of Participants With Second Intervention to Place an Additional MitraClip Device - 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.
Timepoint [58] 0 0
Through 12 months
Secondary outcome [59] 0 0
Rate of Patients Rehospitalized - Defined as re-admission of patients to the hospital following discharge from the Clip procedure.
Timepoint [59] 0 0
30 days
Secondary outcome [60] 0 0
Duration of Rehospitalization
Timepoint [60] 0 0
30 days
Secondary outcome [61] 0 0
Number of Participants at Discharge Facility - This is the economic data reported to support the MitraClip System economic analysis.
Timepoint [61] 0 0
< or = 12 days
Secondary outcome [62] 0 0
Post-procedure Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-anesthesia Care Unit (PACU) Duration - 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.
Timepoint [62] 0 0
Post index procedure within 30 days
Secondary outcome [63] 0 0
Post-procedure Hospital Stay - 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.
Timepoint [63] 0 0
Post index procedure within 30 days

Eligibility
Key inclusion criteria
- Age 18 years or older.

- MR = 3+ .

- Transseptal catheterization and femoral vein access feasible.

- Placement of the MitraClip device on mitral leaflets feasible.

- Mitral valve orifice area = 4.0 cm2.

- Written informed consent obtained.

- The patient agrees to return for follow-up visits.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Need for emergency surgery, other cardiac surgery.

- Coronary artery disease (CAD), atrial fibrillation (AF), other valve disease.

- Prior mitral valve repair surgery, mechanical prosthetic valve, or ventricular assist
device (VAD).

- Active endocarditis or rheumatic heart disease; leaflets degenerated from endocarditis
or rheumatic disease.

- Transesophageal echocardiography (TEE) contraindicated.

- Known hypersensitivity or contraindication to trial or procedure medications which
cannot be managed medically.

- Currently participating in investigational drug trial or another device trial that has
not yet completed the primary endpoint or that interferes with the MitraClip System
ANZ Clinical Trial.

- Pregnant or planning pregnancy within next 12 months.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
St. Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Macquarie University Hosptial - North Ryde
Recruitment hospital [3] 0 0
North Shore Private Hospital - St Leonards
Recruitment hospital [4] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [5] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [6] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2109 - North Ryde
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
4032 - Chermside
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Devices
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Abbott
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of the MitraClip System Australia and New Zealand (ANZ) Clinical Trial
is to gather real-world clinical and health-economic outcome data to support the long-term
safety, efficacy and economic value of the MitraClip System in the continuum of therapies for
treating MR. Specifically, the following clinical and economic data will be collected: New
York Heart Association (NYHA) Functional Class, Six-Minute Walk Test (6MWT) distance, quality
of life (QOL) information, echocardiographic measures of left ventricular size and function,
and data associated with the index hospitalization, rehospitalizations, concomitant
medications and discharge facility to support the MitraClip System economic analysis.
Trial website
https://clinicaltrials.gov/show/NCT01301625
Trial related presentations / publications
Mauri L, Garg P, Massaro JM, Foster E, Glower D, Mehoudar P, Powell F, Komtebedde J, McDermott E, Feldman T. The EVEREST II Trial: design and rationale for a randomized study of the evalve mitraclip system compared with mitral valve surgery for mitral regurgitation. Am Heart J. 2010 Jul;160(1):23-9. doi: 10.1016/j.ahj.2010.04.009.
Whitlow PL, Feldman T, Pedersen WR, Lim DS, Kipperman R, Smalling R, Bajwa T, Herrmann HC, Lasala J, Maddux JT, Tuzcu M, Kapadia S, Trento A, Siegel RJ, Foster E, Glower D, Mauri L, Kar S; EVEREST II Investigators. Acute and 12-month results with catheter-based mitral valve leaflet repair: the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study. J Am Coll Cardiol. 2012 Jan 10;59(2):130-9. doi: 10.1016/j.jacc.2011.08.067.
Tamburino C, Ussia GP, Maisano F, Capodanno D, La Canna G, Scandura S, Colombo A, Giacomini A, Michev I, Mangiafico S, Cammalleri V, Barbanti M, Alfieri O. Percutaneous mitral valve repair with the MitraClip system: acute results from a real world setting. Eur Heart J. 2010 Jun;31(11):1382-9. doi: 10.1093/eurheartj/ehq051. Epub 2010 Mar 18.
Ussia GP, Barbanti M, Tamburino C. Feasibility of percutaneous transcatheter mitral valve repair with the MitraClip system using conscious sedation. Catheter Cardiovasc Interv. 2010 Jun 1;75(7):1137-40. doi: 10.1002/ccd.22415.
Jönsson A, Settergren M. MitraClip catheter-based mitral valve repair system. Expert Rev Med Devices. 2010 Jul;7(4):439-47. doi: 10.1586/erd.10.23.
Argenziano M, Skipper E, Heimansohn D, Letsou GV, Woo YJ, Kron I, Alexander J, Cleveland J, Kong B, Davidson M, Vassiliades T, Krieger K, Sako E, Tibi P, Galloway A, Foster E, Feldman T, Glower D; EVEREST Investigators. Surgical revision after percutaneous mitral repair with the MitraClip device. Ann Thorac Surg. 2010 Jan;89(1):72-80; discussion p 80. doi: 10.1016/j.athoracsur.2009.08.063.
Geidel S, Ostermeyer J, Lass M, Schmoeckel M. Complex surgical valve repair after failed percutaneous mitral intervention using the MitraClip device. Ann Thorac Surg. 2010 Jul;90(1):277-9. doi: 10.1016/j.athoracsur.2009.12.048.
Kalarus Z, Kukulski T, Lekston A, Streb W, Sikora J, Nadziakiewicz P, Gasior M, Polonski L, Zembala M. [Methodology and safety of transvascular reduction of severe ischaemic mitral insufficiency with MitraClip in high-surgical-risk patients - first three cases in Poland]. Kardiol Pol. 2010 Jun;68(6):729-35. Polish.
Lim DS, Kunjummen BJ, Smalling R. Mitral valve repair with the MitraClip device after prior surgical mitral annuloplasty. Catheter Cardiovasc Interv. 2010 Sep 1;76(3):455-9. doi: 10.1002/ccd.22547.
Ciobanu A, Bennett S, Azam M, Clark A, Vinereanu D. Incremental value of three-dimensional transoesophageal echocardiography for guiding double percutaneous MitraClip ® implantation in a 'no option' patient. Eur J Echocardiogr. 2011 Feb;12(2):E11. doi: 10.1093/ejechocard/jeq118. Epub 2010 Sep 27.
Tamburino C, Immè S, Barbanti M, Mulè M, Pistritto AM, Aruta P, Cammalleri V, Scarabelli M, Mangiafico S, Scandura S, Ussia GP. Reduction of mitral valve regurgitation with Mitraclip® percutaneous system. Minerva Cardioangiol. 2010 Oct;58(5):589-98.
Borgia F, Di Mario C, Franzen O. Adenosine-induced asystole to facilitate MitraClip placement in a patient with adverse mitral valve morphology. Heart. 2011 May;97(10):864. doi: 10.1136/hrt.2010.208132. Epub 2010 Oct 29.
Luk A, Butany J, Ahn E, Fann JI, St Goar F, Thornton T, McDermott L, Madayag C, Komtebedde J. Mitral repair with the Evalve MitraClip device: histopathologic findings in the porcine model. Cardiovasc Pathol. 2009 Sep-Oct;18(5):279-85. doi: 10.1016/j.carpath.2008.07.001. Epub 2008 Aug 13.
Herrmann HC, Kar S, Siegel R, Fail P, Loghin C, Lim S, Hahn R, Rogers JH, Bommer WJ, Wang A, Berke A, Lerakis S, Kramer P, Wong SC, Foster E, Glower D, Feldman T; EVEREST Investigators. Effect of percutaneous mitral repair with the MitraClip device on mitral valve area and gradient. EuroIntervention. 2009 Jan;4(4):437-42.
Feldman T, Kar S, Rinaldi M, Fail P, Hermiller J, Smalling R, Whitlow PL, Gray W, Low R, Herrmann HC, Lim S, Foster E, Glower D; EVEREST Investigators. Percutaneous mitral repair with the MitraClip system: safety and midterm durability in the initial EVEREST (Endovascular Valve Edge-to-Edge REpair Study) cohort. J Am Coll Cardiol. 2009 Aug 18;54(8):686-94. doi: 10.1016/j.jacc.2009.03.077.
Rogers JH, Yeo KK, Carroll JD, Cleveland J, Reece TB, Gillinov AM, Rodriguez L, Whitlow P, Woo YJ, Herrmann HC, Young JN. Late surgical mitral valve repair after percutaneous repair with the MitraClip system. J Card Surg. 2009 Nov-Dec;24(6):677-81. doi: 10.1111/j.1540-8191.2009.00901.x. Epub 2009 Jul 24.
Silvestry FE, Rodriguez LL, Herrmann HC, Rohatgi S, Weiss SJ, Stewart WJ, Homma S, Goyal N, Pulerwitz T, Zunamon A, Hamilton A, Merlino J, Martin R, Krabill K, Block PC, Whitlow P, Tuzcu EM, Kapadia S, Gray WA, Reisman M, Wasserman H, Schwartz A, Foster E, Feldman T, Wiegers SE. Echocardiographic guidance and assessment of percutaneous repair for mitral regurgitation with the Evalve MitraClip: lessons learned from EVEREST I. J Am Soc Echocardiogr. 2007 Oct;20(10):1131-40. Epub 2007 Jun 13.
Herrmann HC, Rohatgi S, Wasserman HS, Block P, Gray W, Hamilton A, Zunamon A, Homma S, Di Tullio MR, Kraybill K, Merlino J, Martin R, Rodriguez L, Stewart WJ, Whitlow P, Wiegers SE, Silvestry FE, Foster E, Feldman T. Mitral valve hemodynamic effects of percutaneous edge-to-edge repair with the MitraClip device for mitral regurgitation. Catheter Cardiovasc Interv. 2006 Dec;68(6):821-8.
Feldman T, Foster E, Glower DD, Kar S, Rinaldi MJ, Fail PS, Smalling RW, Siegel R, Rose GA, Engeron E, Loghin C, Trento A, Skipper ER, Fudge T, Letsou GV, Massaro JM, Mauri L; EVEREST II Investigators. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med. 2011 Apr 14;364(15):1395-406. doi: 10.1056/NEJMoa1009355. Epub 2011 Apr 4. Erratum in: N Engl J Med. 2011 Jul 14;365(2):189. Glower, Donald G [corrected to Glower, Donald D].
Ladich E, Michaels MB, Jones RM, McDermott E, Coleman L, Komtebedde J, Glower D, Argenziano M, Feldman T, Nakano M, Virmani R; Endovascular Valve Edge-to-Edge Repair Study (EVEREST) Investigators. Pathological healing response of explanted MitraClip devices. Circulation. 2011 Apr 5;123(13):1418-27. doi: 10.1161/CIRCULATIONAHA.110.978130. Epub 2011 Mar 21.
Siegel RJ, Biner S, Rafique AM, Rinaldi M, Lim S, Fail P, Hermiller J, Smalling R, Whitlow PL, Herrmann HC, Foster E, Feldman T, Glower D, Kar S; EVEREST Investigators. The acute hemodynamic effects of MitraClip therapy. J Am Coll Cardiol. 2011 Apr 19;57(16):1658-65. doi: 10.1016/j.jacc.2010.11.043.
Grayburn PA, Roberts BJ, Aston S, Anwar A, Hebeler RF Jr, Brown DL, Mack MJ. Mechanism and severity of mitral regurgitation by transesophageal echocardiography in patients referred for percutaneous valve repair. Am J Cardiol. 2011 Sep 15;108(6):882-7. doi: 10.1016/j.amjcard.2011.05.013. Epub 2011 Jul 7.
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Auricchio A, Schillinger W, Meyer S, Maisano F, Hoffmann R, Ussia GP, Pedrazzini GB, van der Heyden J, Fratini S, Klersy C, Komtebedde J, Franzen O; PERMIT-CARE Investigators. Correction of mitral regurgitation in nonresponders to cardiac resynchronization therapy by MitraClip improves symptoms and promotes reverse remodeling. J Am Coll Cardiol. 2011 Nov 15;58(21):2183-9. doi: 10.1016/j.jacc.2011.06.061.
Conradi L, Treede H, Franzen O, Seiffert M, Baldus S, Schirmer J, Meinertz T, Reichenspurner H. Impact of MitraClip™ therapy on secondary mitral valve surgery in patients at high surgical risk. Eur J Cardiothorac Surg. 2011 Dec;40(6):1521-6. doi: 10.1016/j.ejcts.2011.03.007. Epub 2011 Apr 15.
Divchev D, Kische S, Paranskaya L, Schneider H, Rehders T, Ortak J, Akin I, Turan G, Turan CH, Steinhoff G, Nöldge-Schomburg G, Nienaber CA, Ince H. In-hospital outcome of patients with severe mitral valve regurgitation classified as inoperable and treated with the MitraClip® device. J Interv Cardiol. 2012 Apr;25(2):180-9. doi: 10.1111/j.1540-8183.2011.00688.x. Epub 2011 Dec 21.
Franzen O, van der Heyden J, Baldus S, Schlüter M, Schillinger W, Butter C, Hoffmann R, Corti R, Pedrazzini G, Swaans MJ, Neuss M, Rudolph V, Sürder D, Grünenfelder J, Eulenburg C, Reichenspurner H, Meinertz T, Auricchio A. MitraClip® therapy in patients with end-stage systolic heart failure. Eur J Heart Fail. 2011 May;13(5):569-76. doi: 10.1093/eurjhf/hfr029. Epub 2011 Apr 6.
Gaemperli O, Moccetti M, Surder D, Biaggi P, Hurlimann D, Kretschmar O, Buehler I, Bettex D, Felix C, Luscher TF, Falk V, Grunenfelder J, Corti R. Acute haemodynamic changes after percutaneous mitral valve repair: relation to mid-term outcomes. Heart. 2012 Jan;98(2):126-32. doi: 10.1136/heartjnl-2011-300705. Epub 2011 Oct 7.
Pleger ST, Mereles D, Schulz-Schönhagen M, Krumsdorf U, Chorianopoulos E, Rottbauer W, Katus HA, Bekeredjian R. Acute safety and 30-day outcome after percutaneous edge-to-edge repair of mitral regurgitation in very high-risk patients. Am J Cardiol. 2011 Nov 15;108(10):1478-82. doi: 10.1016/j.amjcard.2011.06.069. Epub 2011 Sep 3.
Rudolph V, Knap M, Franzen O, Schlüter M, de Vries T, Conradi L, Schirmer J, Treede H, Wegscheider K, Costard-Jäckle A, Meinertz T, Reichenspurner H, Baldus S. Echocardiographic and clinical outcomes of MitraClip therapy in patients not amenable to surgery. J Am Coll Cardiol. 2011 Nov 15;58(21):2190-5. doi: 10.1016/j.jacc.2011.07.047.
Schillinger W, Athanasiou T, Weicken N, Berg L, Tichelbäcker T, Puls M, Hünlich M, Wachter R, Helms HJ, Seipelt R, Schöndube FA, Hasenfuss G. Impact of the learning curve on outcomes after percutaneous mitral valve repair with MitraClip and lessons learned after the first 75 consecutive patients. Eur J Heart Fail. 2011 Dec;13(12):1331-9. doi: 10.1093/eurjhf/hfr141. Epub 2011 Oct 24. Erratum in: Eur J Heart Fail. 2012 Jun;14(6):679.
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Public notes

Contacts
Principal investigator
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David Muller, MD
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St Vincent's Hospital - Sydney, Australia
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Contact person for public queries
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Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01301625