Ventricular Remodeling, Left
Conditions
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.
Interventions
DEVICEMitraClip
Study participants will be randomized to MitraClip device to determine treatment efficacy in improving LV remodelling or functional capacity.
DRUGMedical Therapy
Study participants will be randomized to medical therapy to determine treatment efficacy in improving LV remodelling or functional capacity.
Sponsors
Abbott Medical Devices
Montreal Heart Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized study of MitraClip vs. 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Study participants must meet ALL of the following inclusion criteria in order to be eligible for this study: 1. Male or female ≥18 years of age; 2. Moderate (2+,2-3+) functional mitral regurgitation due to cardiomyopathy of either ischemic or non-ischemic etiology as determined by transthoracic echocardiogram (TTE), and confirmed by the Echocardiography Core Lab (ECL); 3. Left ventricular ejection fraction (LVEF) \>20%, as determined by transthoracic echocardiogram (TTE), and confirmed by the Echocardiography Core Lab (ECL); 4. Symptomatic heart failure as defined by NYHA class II, III or ambulatory IV and NT-proBNP as follows: * NT-proBNP \> 300 pg/mL in patients with sinus rhythm * NT-proBNP \> 600 pg/mL in patients with atrial fibrillation 5. Treatment and compliance with medical therapy for heart failure for at least 30 days; Optimal medical therapy is defined by: a. Maximum tolerated beta-blocker, angiotensin converting enzyme inhibitor (ACE) or angiotensin receptor blocker (ARB), Entresto (valsartan/sacubitril), Ivabradine and aldosterone antagonist (as per the ACC/AHA Guidelines and Canadian Cardiovascular Society Heart Failure Guidelines or other therapies (including SGLT2 inhibitors) as judged by the HF specialist investigator on site and confirmed by the Clinical Eligibility Committee. 6. Clinical agreement amongst local investigators that the patient will not be offered surgical intervention; 7. The primary regurgitant jet, in the opinion of the MitraClip implanting investigator, can successfully be treated by the MitraClip. Treatment of commissural mitral regurgitation may be treated at the discretion of the operator. All major jets contributing the secondary MR will be treated with the MitraClip; 8. Ability to perform a six-minute walk test (6MWT) without substantial physical limitations and without use of a walker or wheelchair and distance walked in 6 minutes of ≤ 450m; 9. Ability and willingness to give written informed consent and to comply with the requirements of the study.
Exclusion criteria
Study participants meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change In Mitral Regurgitation | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Mitral Regurgitation Severity at 24 Months | 24 months | To evaluate the effects of MitraClip and medical therapy on change from baseline in mitral regurgitation severity at 24 months. |
| Change in Mitral Regurgitation Severity at 12 Months | 12 months | To evaluate the effects of MitraClip and medical therapy on change from baseline in mitral regurgitation severity at 12 months. |
| Change in Quality of Life Assessment | 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. |
Countries
Canada
Outcome results
None listed