Heart Failure, Mitral Regurgitation, Mitral Valve Regurgitation Due to Cardiomyopathy (Disorder)
Conditions
Keywords
mitral regurgitation, transcatheter mitral valve repair
Brief summary
This study evaluates the addition of transcatheter mitral valve repair with the MitraClip device to medical treatment in patients with heart failure and moderate functional mitral regurgitation to determine the impact of left ventricular remodelling and patients' functional capacity.
Detailed description
Moderate mitral regurgitation in patients with LV dysfunction is associated with increased risk of death and hospitalizations for heart failure (HF) and leads to progressive remodelling of an already damaged left ventricle. Medical therapies and cardiac resynchronization therapy (CRT) have demonstrated favourable effects on LV remodelling in heart failure patients. Given the benefits and safety of transcatheter mitral valve repair with the MitraClip device in severe MR, it is conceivable that this technology could also be safely used in those with moderate MR to reduce mitral regurgitation, improve symptoms and result in LV remodelling. At present, the optimal treatment strategy for heart failure patients and moderate (2+, 2-3+) mitral regurgitation is uncertain therefore the EVOLVE-MR study proposes to evaluate transcatheter mitral valve repair with the MitraClip in such patients to study the effects on LV remodelling and functional capacity. EVOLVE-MR is a randomized study of MitraClip and medical therapy in symptomatic heart failure patients with moderate (2+, 2-3+) secondary mitral regurgitation. The objective of this study is to determine the impact of both therapies on left ventricular remodelling and functional capacity of the target patient population.
Interventions
Transcatheter mitral valve repair performed using the MitraClip device
Standard medical therapy for heart failure as recommended by HF guidelines
Sponsors
Abbott Medical Devices
Montreal Heart Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Patients will be randomized 1:1 to medical treatment or intervention with the MitraClip device
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Moderate functional mitral regurgitation (2+, 2-3+) * Left ventricular ejection fraction \>20% * LVEDV 75-110 ml/m2 * Symptomatic heart failure (NYHA Class II-IV)
Exclusion criteria
* Left ventricular ejection fraction \< 20% * Severe functional mitral regurgitation * Recent coronary artery bypass graft surgery (CABG) * Untreated significant coronary artery disease * Mitral valve area \< 4.0cm2 * Severe pulmonary hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular diastolic remodelling | 12 months | Change in indexed left ventricular diastolic volume (LVEDV) |
| Functional capacity as measured by 6 minute walk test | 12 months | Change in distance walked on six-minute walk test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mitral regurgitation Severity (RV) | 12 months | Change in mitral regurgitant volume |
| Mitral regurgitation Severity (EROA) | 12 months | Change in effective regurgitant orifice area |
| Quality of Life Measurement | 12 months | Change in indices of quality of life as measured by Kansas City Cardiomyopathy Questionnaire. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. |
Countries
Canada
Contacts
Primary ContactAnita W Asgar, MD
Outcome results
None listed