Heart Failure Clinical Trial
Official title:
EValuation of Outcomes of Transcatheter Mitral Valve Repair for the Treatment of Low Ejection Fraction and Moderate Functional Mitral ValvE Regurgitation In Heart Failure
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.
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.
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