The purpose of this study is to evaluate the safety and effectiveness of an investigational medical device called the MitraClip Mitral Valve Repair System (MitraClip System) in patients with severe primary mitral regurgitation who are at moderate surgical risk. The main procedures of the study include surgical mitral valve repair or MitraClip Mitral valve repair. Primary mitral regurgitation happens when the heart’s mitral valve is diseased or damaged and does not close tightly, which causes blood to flow backward in the heart. Stopping or decreasing mitral regurgitation helps blood to flow more efficiently through the heart and to the rest of the body. The MitraClip System consists of a delivery catheter and an implantable clip; it is designed to access the mitral valve in the heart via a minimally invasive transcatheter procedure and clip the two mitral valve leaflets together. This clipping process decreases mitral regurgitation and thus repairs the diseased or damaged mitral valve. The study will provide information that may help make the MitraClip device more widely available to people with the primary mitral valve disease.
What is the full name of this clinical trial?
Percutaneous MitraClipTM Device or Surgical Mitral Valve REpair in PAtients with PrImaRy Mitral Regurgitation who are Candidates for Surgery