Study detail
RecruitingObservational
SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access
Edwards Lifesciences
Summary
This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
Description
This is a prospective single-arm, multicenter study.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No