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3-Year Interim Results of the Percutaneous MONARC™ System for the Treatment of Functional Mitral Regurgitation
Functional mitral regurgitation (FMR) is frequently observed in heart failure pts with ischemic or dilated cardiomyopathy and associated with poor prognosis. The aim of the prospective, multicenter, non randomized feasibility study was to assess the safety and efficacy of a percutaneous coronary sinus approach, with the MONARC system to reduce FMR up to 3-years. Primary objective of the study is to evaluate the acute safety (30d, 90d) of the MONARC system in treating functional mitral regurgitation in heart failure patients. Secondary objective of the study is reduction in MR by at least one grade at 90 days.
The device is delivered within the coronary sinus via a jugular venous approach The device is composed of 3 components: Self expanding distal anchor, Self expanding proximal anchor and Bridge connecting the anchors.
A biodegradable suture is wound on the bridge and acts as a temporary spacer to hold the spring open in an elongated state. Over about 6 weeks, the suture material dissolves, and the bridge compresses, shortening the coronary sinus
Implantation of the MONARC system is feasible, easy and reproducible. The 3-years data shows 64% of patients are event free compared to baseline. And encouraging 36-months results compared to baseline in respect to MR reduction and clinical functional NYHA class reduction.
EVOLUTION I is solely a safety study. It has a small 3-year sample size and no control group which gave limited insight to clinical benefit.
EVOLUTION II is underway taking into account the lessons learned from EVOLUTION I including a prospective control group, MR and hemodynamic responses and clinical outcomes measuring NYHA class, 6MWT and QoL.
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