Evaluation of the Safety and Performance of the Half Moon Transcatheter Mitral Valve Repair System in High Risk Patients With Severe, Symptomatic Mitral Regurgitation
Half Moon Medical
Summary
The study is a prospective, multi-center, single-arm, non-randomized, Early Feasibility Study (EFS) to evaluate the safety and performance of the Half Moon TMVr System in patients with severe, symptomatic mitral regurgitation, who are at high risk for conventional mitral valve surgery.
Eligibility
- Age range
- 21–95 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: 1. Moderately severe or severe mitral regurgitation (MR Grade ≥ 3+) 2. Symptomatic mitral regurgitation (NYHA Class II-IV), despite guideline-directed medical therapy (GDMT) determined by the local multidisciplinary heart team 3. Deemed, by the local multidisciplinary heart team, to be at high risk for mitral valve surgery and not appropriate for commercially approved transcatheter mitral valve therapies 4. Age ≥ 21 5. Native mitral valve geometry and size compatible with the Half Moon TMVr implant 6. Anatomy suitable for transfemoral transseptal access with the Half M…
Interventions
- DeviceHalf Moon TMVr System
The Half Moon Transcatheter Mitral Valve Repair (TMVr) System is designed for transfemoral access and transseptal delivery of a self-expanding implant that restores competency in a regurgitant mitral valve.
Locations (5)
- Columbia University Medical Center/NewYork Presbyterian HospitalNew York, New York
- Montefiore Medical CenterThe Bronx, New York
- University Hospitals Cleveland Medical CenterCleveland, Ohio
- Oregon Health & Science UniversityPortland, Oregon
- UPMC Heart & Vascular InstituteHarrisburg, Pennsylvania