Status:
COMPLETED
Multicenter International Trial Ring AnnulopLasty
Lead Sponsor:
Abbott Medical Devices
Conditions:
Mitral Valve Insufficiency
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This clinical study is a multicenter, prospective non-randomized observational study without concurrent or matched controls in which 150 patients receiving an SJM® Rigid Saddle Ring will be included. ...
Eligibility Criteria
Inclusion
- Patient requiring a mitral valve repair due to mitral degenerative or functional disease (Note: Patients that underwent concomitant procedures, e.g. coronary artery bypass grafting, are eligible for this study);
- Patient (or legal guardian) has signed a study specific informed consent form agreeing to the data collection and follow-up requirements;
- Patients are at least 18 years old.
Exclusion
- Patient requires replacement of the aortic, tricuspid or pulmonary valve or has a pre-existing prosthetic valve;
- Patient is pregnant or nursing;
- Patient has active endocarditis;
- Patient is actively participating in another study of an investigational drug or device;
- Patients unavailable to follow-up visit (abroad residents, patients affected by neurological disorders...);
- Patients who are intravenous drug abusers, alcohol abusers, prison inmates or unable to give informed consent;
- Patients with a major non-cardiac evolving disease;
- Patients with a life expectancy less than 1 year;
- Patients are known to be noncompliant or are unlikely to complete the study;
- Any case in which mitral annuloplasty rings are not indicated;
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00727012
Start Date
June 1 2008
End Date
November 1 2010
Last Update
February 4 2019
Active Locations (1)
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1
University of Heidelberg
Heidelberg, Germany, 69120