Feasibility Study of a Percutaneous Mitral Valve Repair System.

Completed · Phase 1/Phase 2

Conditions studied: Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation, Mitral Insufficiency

In brief

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.

Key facts

Study ID

NCT00209339

Run by

Abbott Medical Devices

People needed

55

Starts

2003-07-01

Expected to finish

2011-10-01

Last updated by the study team

2018-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Ejection fraction < 30%
• Endocarditis
• Rheumatic heart disease
• Renal insufficiency

Where it is running

• Evanston Northwestern Healthcare — Evanston, Illinois, United States

Full record on ClinicalTrials.gov

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