IRB Study Number 21-459
Status Recruiting
Phase Not Applicable
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
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 due to clinical, anatomic or technical considerations.
Inclusion Criteria
- 18 years or older
- MR>/= 3+ as assessed by the Echo Core Lab
- NYHA functional class >/= II
- Further inclusion criteria will be reviewed by study staff
Exclusion Criteria
- Mitral/cardiac anatomy that would preclude appropriate delivery and deployment of the dock or valve
- Inappropriate anatomy for femoral introduction and delivery of the SAPIEN M3 Dock and Valve
- Presence of any device that will contact or interfere with the SAPIEN M3 System during delivery or after implantation
- Further exclusion criteria will be reviewed by study staff
