Feasibility Study of a Percutaneous Mitral Valve Repair System.
Feasibility Study of a Percutaneous Mitral Valve Repair System.
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.
Inclusion Criteria:

 -  Have moderate to severe mitral regurgitation, symptomatic or asymptomatic with
 evidence of left ventricular dysfunction;

 -  Experience regurgitation origination from the central two-thirds of the valve;

 -  Qualify as a candidate for mitral valve surgery including cardiopulmonary bypass.

 Exclusion Criteria:

 -  Ejection fraction < 30%

 -  Endocarditis

 -  Rheumatic heart disease

 -  Renal insufficiency