Multicenter International Trial Ring AnnulopLasty

Multicenter International Trial Ring AnnulopLasty

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. The primary objective of the study is to demonstrate the effectiveness of the SJM® Rigid Saddle Ring when used in mitral valve repair procedures.

Inclusion Criteria:

• 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 Criteria:

• 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;