ENCIRCLE
The ENCIRCLE Trial
AI 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.
Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
- Who can join
- adult, older adult
- Participants
- 900
- Expected completion
- 2031-02-28
- Funded by
- industry
Conditions studied
Mitral Regurgitation, Mitral Valve Insufficiency
What is being tested
- DEVICE: SAPIEN M3 valve and dock
What it measures
- Non-hierarchical composite of death and heart failure rehospitalization, Number of subjects with death and/or heart failure rehospitalization, 1 year
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Abbott Northwestern Hospital
Minneapolis, MN
Allegheny General Hospital
Pittsburgh, PA
Ascension Saint Thomas Hospital
Nashville, TN
Ascension Seton Medical Center Austin
Austin, TX
Ascension St. Vincent Heart Center
Carmel, IN
Ascension St. Vincent's Riverside
Jacksonville, FL
Atrium Health Carolinas Medical Center
Charlotte, NC
Banner – University Medical Center Phoenix
Phoenix, AZ
Brigham and Women's Hospital
Boston, MA
California Pacific Medical Center (Van Ness Campus)
San Francisco, CA
Carilion Roanoke Memorial Hospital
Roanoke, VA
Cedars-Sinai Medical Center
Los Angeles, CA
CentraCare – St. Cloud Hospital
Saint Cloud, MN
Cleveland Clinic
Cleveland, OH
Delray Medical Center
Delray Beach, FL
Dignity Health St. Joseph's Hospital and Medical Center
Phoenix, AZ
Emory University Hospital Midtown
Atlanta, GA
HCA Florida North Florida Hospital
Gainesville, FL
HCA Houston Healthcare Medical Center
Houston, TX
Henry Ford Health (Detroit)
Detroit, MI
Hillcrest Medical Center
Tulsa, OK
Huntsville Hospital
Huntsville, AL
Intermountain Medical Center
Murray, UT
Kaleida Health
Buffalo, NY
Massachusetts General Hospital
Boston, MA
Mayo Clinic (Rochester, Minnesota)
Rochester, MN
MedStar Union Memorial Hospital
Baltimore, MD
Memorial Hermann-Texas Medical Center
Houston, TX
Morristown Medical Center
Morristown, NJ
Mount Carmel East
Columbus, OH
Naples Comprehensive Health (NCH)
Naples, FL
NewYork-Presbyterian Hospital
New York, NY
Novant Health Presbyterian Medical Center
Charlotte, NC
Oklahoma Heart Hospital (Oklahoma City)
Oklahoma City, OK
Our Lady of the Lake Regional Medical Center
Baton Rouge, LA
Penn State Health Holy Spirit Medical Center
Camp Hill, PA
Piedmont Atlanta Hospital
Atlanta, GA
PIH Health Good Samaritan Hospital
Los Angeles, CA
Providence St. Joseph Hospital Orange
Orange, CA
Providence St. Patrick Hospital
Missoula, MT
Robert Wood Johnson University Hospital
New Brunswick, NJ
Rush University Medical Center
Chicago, IL
Saint Luke’s Hospital of Kansas City
Kansas City, MO
Sarasota Memorial Hospital
Sarasota, FL
Scripps Memorial Hospital La Jolla
La Jolla, CA
Sentara Norfolk General Hospital
Norfolk, VA
The Christ Hospital
Cincinnati, OH
The University of Kansas Health System
Kansas City, KS
Tucson Medical Center
Tucson, AZ
UCHealth Medical Center of the Rockies
Loveland, CO
University Hospital
Madison, WI
University of Washington Medical Center
Seattle, WA
Registry entry updated 2026-02-25
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.