Status:
COMPLETED
Feasibility Study of a Percutaneous Mitral Valve Repair System.
Lead Sponsor:
Abbott Medical Devices
Conditions:
Mitral Valve Insufficiency
Mitral Valve Regurgitation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Detailed Description
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 prospect...
Eligibility Criteria
Inclusion
- 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
- Ejection fraction \< 30%
- Endocarditis
- Rheumatic heart disease
- Renal insufficiency
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00209339
Start Date
July 1 2003
End Date
October 1 2011
Last Update
November 7 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Evanston Northwestern Healthcare
Evanston, Illinois, United States, 60201