SAPIEN M3 EFS
SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation
AI Description
This study will evaluate the safety and functionality of the SAPIEN M3 System in patients with symptomatic, severe MR and will provide guidance for future clinical study designs utilizing the SAPIEN M3 System.
- Who can join
- adult, older adult
- Participants
- 72
- Expected completion
- 2027-08-31
- Funded by
- industry
Conditions studied
Mitral Disease, Mitral Regurgitation
What is being tested
- DEVICE: Edwards SAPIEN M3 System
What it measures
- Technical Success, Defined as meeting all the following: * Alive * Successful access, delivery and retrieval of the delivery systems * Deployment of the devices in the intended position * Freedom from emergency surgery or reintervention related to the device or access procedure, At the end of the procedure
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
California Pacific Medical Center (Van Ness Campus)
San Francisco, CA
Cedars-Sinai Medical Center
Los Angeles, CA
Emory University Hospital Midtown
Atlanta, GA
Endeavor Health Evanston Hospital
Evanston, IL
Henry Ford Health (Detroit)
Detroit, MI
Intermountain Medical Center
Murray, UT
Mayo Clinic (Rochester, Minnesota)
Rochester, MN
Sentara Norfolk General Hospital
Norfolk, VA
Registry entry updated 2026-07-17
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.