EValuation of Outcomes of Transcatheter Mitral Valve Repair for the Treatment of Low Ejection Fraction and Moderate Functional Mitral ValvE Regurgitation In Heart Failure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mitral Regurgitation
- Sponsor
- Montreal Heart Institute
- Enrollment
- 174
- Locations
- 1
- Primary Endpoint
- Left ventricular diastolic remodelling
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Left ventricular diastolic remodelling
Time Frame: 12 months
Change in indexed left ventricular diastolic volume (LVEDV)
Functional capacity as measured by 6 minute walk test
Time Frame: 12 months
Change in distance walked on six-minute walk test
Secondary Outcomes
- Quality of Life Measurement(12 months)
- Mitral regurgitation Severity (EROA)(12 months)
- Mitral regurgitation Severity (RV)(12 months)