What is the Purpose of this Study?
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.
Eligibility
- 1. Subject has severe (Grade III or greater per the ASE criteria, which includes severity grades of 3+ and 4+) primary MR (mixed etiology is acceptable provided the principal mechanism of action is a degenerative mitral valve) as assessed by the ECL.
- 2. The cardiac surgeon of the Site Heart Team (consisting of at least one interventionalist, and one cardiac surgeon) has confirmed that the subject is a candidate for mitral valve surgery and the EC have confirmed that the subject's mitral valve anatomy is suitable for percutaneous repair with the MitraClip™ device with high certainty of achieving MR ≤ mild
- 3. Subject is symptomatic (NYHA Class II/III/IV) or asymptomatic with LVEF ≤ 60%, pulmonary artery systolic pressure \> 50 mmHg, or LVESD \> 40 mm
- 4. Subject is at moderate surgical risk defined as being at least 75 years of age at the time of EC review. If younger than 75 years, then the subject should have:
Where can I participate?
Beverly
More about this Clinical Trial
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