Early Feasibility Study of the CardioMech Mitral Valve Repair System (MVRS)
CardioMech AS
Summary
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
Description
The purpose of the clinical study is to obtain clinical data on the CardioMech Mitral Valve Repair System (MVRS) in patients diagnosed with moderate to severe (≥3+) or severe (≥4+), symptomatic, degenerative mitral regurgitation and who are determined to be at intermediate or high surgical risk for mitral valve repair, as assessed by the site's multidisciplinary heart team.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No