EValuation of Outcomes of MitraCLip for the Treatment of Moderate Functional Mitral ValvE Regurgitation In Heart Failure
Overview
- Phase
- Not Applicable
- Intervention
- MitraClip
- Conditions
- Ventricular Remodeling, Left
- Sponsor
- Montreal Heart Institute
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Change In Mitral Regurgitation
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
The study compares the effectiveness of treatment with MitraClip to medical therapy in improving the reduction of cardiovascular morbidity and functional capacity at 24 months, in patients with moderate functional mitral regurgitation.
Detailed Description
Primary Objective To compare the effectiveness of treatment with MitraClip to medical therapy on the change from baseline to 24 months in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score in patients with moderate functional mitral regurgitation. Secondary Objectives * To evaluate the effects of MitraClip and medical therapy on change from baseline in mitral regurgitation severity at 24 months. * To evaluate the effects of MitraClip and medical therapy on change from baseline in mitral regurgitation severity at 12 months. * To evaluate the effects of MitraClip and medical therapy on change in quality of life from baseline to 12 months, as measured by the KCCQ. Tertiary Objectives * To evaluate the effects of MitraClip and medical therapy on change from baseline in functional capacity (distance walked on a 6MWT) at 12 and 24 Months. * To evaluate the effects of MitraClip and medical therapy on change from baseline in quality of life, as measured by the EQ5DL questionnaire, at 12 and 24 months. * To evaluate the effects of MitraClip and medical therapy on freedom from progression to severe MR at 24 months as assessed by echocardiography. * To evaluate the effects of MitraClip and medical therapy on change from baseline in LVEDVi at 24 months. Exploratory Objectives * To evaluate the effects of MitraClip and medical therapy on functional class, biomarkers, clinical events, parameters of physical activity, other echocardiographic parameters and health economic assessments. * To evaluate the effects of MitraClip and medical therapy on all hospitalizations for decompensated heart failure, including episodes of outpatient treatment intensification in a HF clinic or emergency department visits, at 24 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
MitraClip
Study of MitraClip in symptomatic heart failure patients with moderate (2+, 2-3+) functional mitral regurgitation and left ventricular dysfunction. Subjects will be followed for 24 months and there will be one formal interim analysis for futility after approximately 50% of subjects have completed their 24-month follow-up.
Intervention: MitraClip
MitraClip
Study of MitraClip in symptomatic heart failure patients with moderate (2+, 2-3+) functional mitral regurgitation and left ventricular dysfunction. Subjects will be followed for 24 months and there will be one formal interim analysis for futility after approximately 50% of subjects have completed their 24-month follow-up.
Intervention: Medical Therapy
Medical Therapy
Study of medical therapy in symptomatic heart failure patients with moderate (2+, 2-3+) functional mitral regurgitation and left ventricular dysfunction. Subjects will be followed for 24 months and there will be one formal interim analysis for futility after approximately 50% of subjects have completed their 24-month follow-up.
Intervention: MitraClip
Medical Therapy
Study of medical therapy in symptomatic heart failure patients with moderate (2+, 2-3+) functional mitral regurgitation and left ventricular dysfunction. Subjects will be followed for 24 months and there will be one formal interim analysis for futility after approximately 50% of subjects have completed their 24-month follow-up.
Intervention: Medical Therapy
Outcomes
Primary Outcomes
Change In Mitral Regurgitation
Time Frame: 24 months
To compare the effectiveness of treatment with MitraClip to medical therapy on the change from baseline to 24 months in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score in patients with moderate functional mitral regurgitation
Secondary Outcomes
- Change in Quality of Life Assessment(12 months)
- Change in Mitral Regurgitation Severity at 12 Months(12 months)
- Change in Mitral Regurgitation Severity at 24 Months(24 months)