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
Inclusion Criteria: 1. 18 years of age or older 2. MR ≥ 3+ 3. NYHA functional class ≥ II 4. Per the Heart Team, commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomic or technical considerations. 5. Subject's heart failure management has been optimized based on subject characteristics and applicable guidelines, and stable for at least 30 days prior to enrollment. 6. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. Exclusion…
Interventions
- DeviceSAPIEN M3 valve and dock
During the procedure a SAPIEN M3 dock and a SAPIEN M3 valve will be implanted via transseptal approach.
Locations (68)
- Heart Center HospitalHuntsville, Alabama
- Banner University Medical CenterPhoenix, Arizona
- Saint Josephs Hospital Medical Center Dignity HealthPhoenix, Arizona
- TMC HealthcareTucson, Arizona
- Scripps HealthLa Jolla, California
- Good Samaritan HospitalLos Angeles, California