Condition: Mitral regurgitation
Key Inclusion Criteria:
- Severe primary mitral regurgitation (MR)
- Confirmation that the participant is a candidate for mitral valve surgery, and mitral valve anatomy is suitable for percutaneous repair with the MitraClip device with high certainty of achieving MR ≤ mild
- At least 18 years old
Key Exclusion Criteria:
- Currently participating in another clinical investigation
- Presence of other anatomic or comorbid conditions, or other conditions that could limit the ability to participate, comply with follow-up requirements or impact the scientific soundness of clinical investigation results
- Ischemic or non-ischemic secondary MR
Percutaneous MitraClip Device or Surgical Mitral Valve Repair in Patients With Primary Mitral Regurgitation who are Candidates for Surgery (REPAIR MR) (IRB no. 00001522)
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.