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MitraClip System in Australia and New Zealand (MitraClipANZ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01301625
Recruitment Status : Terminated (As recruitment rate was lower than anticipated)
First Posted : February 23, 2011
Results First Posted : October 22, 2018
Last Update Posted : October 22, 2018
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Evalve

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.

Condition or disease Intervention/treatment
Mitral Regurgitation Device: MitraClip Implant

Detailed Description:

The MitraClip System ANZ Clinical Trial is a prospective, observational, single arm, multicenter trial to evaluate the MitraClip device for the treatment of mitral regurgitation (MR). Patients will be enrolled at up to 15 investigational sites throughout Australia and New Zealand. Up to 150 patients will be enrolled. Patients will be considered enrolled when local or general anesthesia is administered for the MitraClip procedure. Patients will be followed at discharge, 30 days, 6 months, 12 months and 24 months.

Investigational sites will recruit consecutive patients who meet trial enrollment criteria. Until enrollment in the MitraClip System ANZ Clinical Trial is closed, all patients who undergo a procedure for placement of a MitraClip device at an investigational site should be enrolled in the MitraClip System ANZ Clinical Trial.


Study Type : Observational
Actual Enrollment : 78 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Single Arm Clinical Trial Evaluating the MitraClip System in Australia and New Zealand
Study Start Date : November 2011
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Group/Cohort Intervention/treatment
MitraClip Implant
Eligible patients undergoing a MitraClip procedure in Australia and New Zealand
Device: MitraClip Implant
Percutaneous mitral valve repair using MitraClip implant.
Other Names:
  • MitraClip System
  • MitraClip Delivery System
  • Steerable Guide Catheter




Primary Outcome Measures :
  1. Percentage of Participants Experiencing Death (Kaplan-Meier Analysis) [ Time Frame: Baseline ]

    Clinical Endpoint.

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

  2. Percentage of Participants Experiencing Death (Kaplan-Meier Analysis) [ Time Frame: 30 days ]

    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).

  3. Percentage of Participants Experiencing Death (Kaplan-Meier Analysis) [ Time Frame: 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).

  4. Percentage of Participants Experiencing Death (Kaplan-Meier Analysis) [ Time Frame: 12 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).


Secondary Outcome Measures :
  1. Number of Participants With 0, 1, 2, and 3 MitraClip Devices Implanted [ Time Frame: 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.

  2. Number of Participants With Acute Procedural Success Rate [ Time Frame: At day 0 (on the day of index procedure) ]
    Defined as successful MitraClip implantation with resulting MR of 2+ or less.

  3. Procedure Time [ Time Frame: At day 0 (on the day of index procedure) ]
    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.

  4. Device Time [ Time Frame: At day 0 (on the day of index procedure) ]
    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.

  5. Fluoroscopy Duration [ Time Frame: At day 0 (on the day of index procedure) ]
    This is one of the Device and Procedure-Related Endpoints. Mean fluoroscopy duration during the MitraClip procedure.

  6. Total Contrast Volume [ Time Frame: At day 0 (on the day of index procedure) ]
    This is one of the Device and Procedure-Related Endpoints.

  7. Left Ventricle End Diastolic Volume (LVEDV) [ Time Frame: At Baseline and Discharge (≤7 days of index procedure) ]
    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.

  8. Left Ventricle End Diastolic Volume (LVEDV) [ Time Frame: At Baseline and 30 Days ]
    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.

  9. Left Ventricle End Diastolic Volume (LVEDV) [ Time Frame: At Baseline and 12 months ]
    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.

  10. Left Ventricular End Systolic Volume (LVESV) [ Time Frame: At Baseline and Discharge (≤7 days of index procedure) ]
    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.

  11. Left Ventricular End Systolic Volume (LVESV) [ Time Frame: At Baseline and 30 Days ]
    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.

  12. Left Ventricular End Systolic Volume (LVESV) [ Time Frame: At Baseline and 12 months ]
    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.

  13. Left Ventricular Ejection Fraction (LVEF) [ Time Frame: At Baseline and Discharge (≤7 days of index procedure) ]
    Left ventricular ejection fraction is assessed by transthoracic echocardiography according to Simpson's rule (biplane method of disks).

  14. Left Ventricular Ejection Fraction (LVEF) [ Time Frame: At Baseline and 30 Days ]
    Left ventricular ejection fraction is assessed by transthoracic echocardiography according to Simpson's rule (biplane method of disks).

  15. Left Ventricular Ejection Fraction (LVEF) [ Time Frame: At Baseline and 12 months ]
    Left ventricular ejection fraction is assessed by transthoracic echocardiography according to Simpson's rule (biplane method of disks).

  16. Number of Participants With MR Severity [ Time Frame: 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.


  17. Number of Participants With MR Severity [ Time Frame: At discharge (≤7 days of index procedure) ]

    Mitral regurgitation severity was determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity was scored using the integrative method based on qualitative and quantitative echocardiographic parameters as described in the ASE guidelines.Site-assessed mitral regurgitation severity using echocardiography.

    MR severity was graded as follows: 0: None, 1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe.


  18. Number of Participants With MR Severity [ Time Frame: 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.


  19. Number of Participants With MR Severity [ Time Frame: 6 months ]

    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.


  20. Number of Participants With MR Severity [ Time Frame: 12 months ]

    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.


  21. Left Ventricular Internal Diameter End Diastole (LVIDd) [ Time Frame: At Baseline and Discharge (≤7 days of index procedure) ]
    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.

  22. Left Ventricular Internal Diameter End Diastole (LVIDd) [ Time Frame: At Baseline and 30 Days ]
    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.

  23. Left Ventricular Internal Diameter End Diastole (LVIDd) [ Time Frame: At Baseline and 12 Months ]
    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.

  24. Left Ventricular Internal Diameter End Systole (LVIDs) [ Time Frame: At Baseline and Discharge (≤7 days of index procedure) ]
    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.

  25. Left Ventricular Internal Diameter End Systole (LVIDs) [ Time Frame: At Baseline and 30 Days ]
    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.

  26. Left Ventricular Internal Diameter End Systole (LVIDs) [ Time Frame: At Baseline and 12 Months ]
    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.

  27. Regurgitant Volume [ Time Frame: At Baseline and Discharge (≤7 days of index procedure) ]
    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.

  28. Regurgitant Volume [ Time Frame: At Baseline and 30 Days ]
    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.

  29. Regurgitant Volume [ Time Frame: At Baseline and 12 Months ]
    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.

  30. Regurgitant Fraction [ Time Frame: At Baseline and Discharge (≤7 days of index procedure) ]
    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.

  31. Regurgitant Fraction [ Time Frame: At Baseline and 30 Days ]
    Regurgitant fraction as determined by the core echo laboratory. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.

  32. Regurgitant Fraction [ Time Frame: At Baseline and 12 Months ]
    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.

  33. Mitral Valve Area (MVA) by Pressure Half-time (PHT) [ Time Frame: At Baseline and Discharge (≤7 days of index procedure) ]
    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.

  34. Mitral Valve Area (MVA) by Pressure Half-time (PHT) [ Time Frame: At Baseline and 30 Days ]
    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.

  35. Mitral Valve Area (MVA) by Pressure Half-time (PHT) [ Time Frame: At Baseline and 12 Months ]
    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.

  36. Mitral Valve Mean Gradient [ Time Frame: At Baseline and Discharge (≤7 days of index procedure) ]
    Mitral valve mean gradient is defined as the mean pressure gradients across the mitral valve as measured by echocardiography.

  37. Mitral Valve Mean Gradient [ Time Frame: At Baseline and 30 Days ]
    Mitral valve mean gradient is defined as the mean pressure gradients across the mitral valve as measured by echocardiography.

  38. Mitral Valve Mean Gradient [ Time Frame: At Baseline and 12 Months ]
    Mitral valve mean gradient is defined as the mean pressure gradients across the mitral valve as measured by echocardiography.

  39. Left Atrial Volume [ Time Frame: At Baseline and Discharge (≤7 days of index procedure) ]
    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.

  40. Left Atrial Volume [ Time Frame: At Baseline and 30 Days ]
    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.

  41. Left Atrial Volume [ Time Frame: At Baseline and 12 Months ]
    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.

  42. Six Minute Walking Distance [ Time Frame: 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.

  43. Six Minute Walking Distance [ Time Frame: 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.

  44. Six Minute Walking Distance [ Time Frame: 6 months ]
    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.

  45. Six Minute Walking Distance [ Time Frame: 12 months ]
    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.

  46. Percentage of Participants With New York Heart Association (NYHA) Class [ Time Frame: Baseline ]
    • Class I Patients with cardiac disease but without resulting limitations of physical activity;
    • Class II Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain;
    • Class III Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain;
    • Class IV Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

  47. Percentage of Participants With New York Heart Association (NYHA) Class [ Time Frame: 30 days ]
    • 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.

  48. Percentage of Participants With New York Heart Association (NYHA) Class [ Time Frame: 6 months ]
    • 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.

  49. Percentage of Participants With New York Heart Association (NYHA) Class [ Time Frame: 12 months ]
    • 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.

  50. Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 30 Days [ Time Frame: 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).


  51. Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 6 Months [ Time Frame: 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).


  52. Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 12 Months [ Time Frame: 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).


  53. Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis) [ Time Frame: Baseline ]

    Death: Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint.

    Death is further divided into 2 categories:

    A. Cardiac death is defined as death due to any of the following:

    • Acute myocardial infarction
    • Cardiac perforation/pericardial tamponade
    • Arrhythmia or conduction abnormality
    • Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
    • Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
    • Any death for which a cardiac cause cannot be excluded.

    B. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

    Congestive Heart Failure (CHF): Defined as a documented diagnosis of CHF on the hospital admission report or discharge summary.


  54. Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis) [ Time Frame: 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.


  55. Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis) [ Time Frame: 6 months ]

    Death: Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint.

    Death is further divided into 2 categories:

    A. Cardiac death is defined as death due to any of the following:

    • Acute myocardial infarction
    • Cardiac perforation/pericardial tamponade
    • Arrhythmia or conduction abnormality
    • Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
    • Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
    • Any death for which a cardiac cause cannot be excluded. B. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

    Congestive Heart Failure (CHF): Defined as a documented diagnosis of CHF on the hospital admission report or discharge summary.


  56. Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis) [ Time Frame: 12 months ]

    Death: Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint.

    Death is further divided into 2 categories:

    A. Cardiac death is defined as death due to any of the following:

    • Acute myocardial infarction
    • Cardiac perforation/pericardial tamponade
    • Arrhythmia or conduction abnormality
    • Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
    • Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
    • Any death for which a cardiac cause cannot be excluded.

    B. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

    Congestive Heart Failure (CHF): Defined as a documented diagnosis of CHF on the hospital admission report or discharge summary.


  57. Number of Participants With Mitral Valve Surgery [ Time Frame: 30 days of Post-MitraClip Procedure ]
    Mital Valve Surgery Post-MitraClip Procedure; Surgery Types includes Replacement and Repair.

  58. Number of Participants With Second Intervention to Place an Additional MitraClip Device [ Time Frame: 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.

  59. Rate of Patients Rehospitalized [ Time Frame: 30 days ]
    Defined as re-admission of patients to the hospital following discharge from the Clip procedure.

  60. Duration of Rehospitalization [ Time Frame: 30 days ]
  61. Number of Participants at Discharge Facility [ Time Frame: < or = 12 days ]
    This is the economic data reported to support the MitraClip System economic analysis.

  62. Post-procedure Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-anesthesia Care Unit (PACU) Duration [ Time Frame: Post index procedure within 30 days ]
    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.

  63. Post-procedure Hospital Stay [ Time Frame: Post index procedure within 30 days ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients eligible to receive the MitraClip implant at the designated investigational sites in Australia and New Zealand.
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01301625


Locations
Australia, New South Wales
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Macquarie University Hosptial
North Ryde, New South Wales, Australia, 2109
North Shore Private Hospital
St Leonards, New South Wales, Australia, 2065
Australia, Queensland
The Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Australia, South Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Evalve
Abbott
Investigators
Principal Investigator: David Muller, MD St Vincent's Hospital - Sydney, Australia
Principal Investigator: Jurgen Passage, FRACs Sir Charles Gairdner Hospital, Perth, Australia

Publications:

Responsible Party: Evalve
ClinicalTrials.gov Identifier: NCT01301625     History of Changes
Other Study ID Numbers: Protocol #M10-001
First Posted: February 23, 2011    Key Record Dates
Results First Posted: October 22, 2018
Last Update Posted: October 22, 2018
Last Verified: January 2018

Keywords provided by Evalve:
MitraClip
mitral regurgitation (MR)
mitral valve insufficiency
percutaneous mitral valve repair
congestive heart failure

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases