IRB Study Number 22-100
Status Recruiting
Phase Not Applicable
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
Evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral regurgitation in whom transcatheter therapy is deemed more appropriate than open heart surgery
Inclusion Criteria
- Mitral regurgitation ≥ Grade III per American Society of Echocardiography criteria
- New York Heart Association (NYHA) Functional Class II, III, or ambulatory IV
- In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery, and the subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, and heart failure
- Additional inclusion criteria will be evaluated by study staff
Exclusion Criteria
- Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function
- Implant or revision of CRT device within 90 days prior to subject procedure date
- Myocardial infarction within 30 days prior to subject procedure date
- Additional exclusion criteria will be evaluated by study staff
