Feasibility Study of a Percutaneous Mitral Valve Repair System.

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