Mitral Regurgitation Clinical Trial
Official title:
A Study of the Evalve Cardiovascular Valve Repair System Endovascular Valve Edge-to-Edge REpair STudy (EVEREST I).
Prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System (CVRS) in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6 month, 12 month, and 5 year clinical follow-up.
Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair
of mitral valve regurgitation using the Evalve Cardiovascular Valve Repair System.
The study is a prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve
Repair System (CVRS) in the treatment of mitral valve regurgitation. A minimum of 20 patients
will be enrolled (an additional maximum of 12 roll in-patients, a maximum of 2 per site, may
be enrolled and analyzed separately). Patients will undergo 30-day, 6 month and 12 month
clinical follow-up.
Up to 12 clinical sites throughout the US may participate.
The primary endpoint is acute safety at thirty days, with a secondary efficacy endpoint of
reduction of MR.
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