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Study identifier: NCT04153292 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

The ENCIRCLE Trial

Condition: Mitral Regurgitation · Mitral Valve Insufficiency  ·  Sponsor: Edwards Lifesciences

PhaseNA
Planned participants900
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Edwards TMTT Clinical Affairs  ·  +1 (949) 250-2500  ·  TMTT_Clinical@edwards.com

Always discuss trial participation with your own doctor first.

Locations (68)

Heart Center HospitalHuntsville, Alabama, United StatesActive Not Recruiting
Banner University Medical CenterPhoenix, Arizona, United StatesActive Not Recruiting
Saint Josephs Hospital Medical Center Dignity HealthPhoenix, Arizona, United StatesActive Not Recruiting
TMC HealthcareTucson, Arizona, United StatesWithdrawn
Scripps HealthLa Jolla, California, United StatesActive Not Recruiting
Good Samaritan HospitalLos Angeles, California, United StatesActive Not Recruiting
Cedars-Sinai Medical CenterLos Angeles, California, United StatesActive Not Recruiting
Kaiser Sunset LALos Angeles, California, United StatesActive Not Recruiting
Saint Joseph HospitalOrange, California, United StatesWithdrawn
California Pacific Medical CenterSan Francisco, California, United StatesActive Not Recruiting
UC Health Northern Colorado (Medical Center of the Rockies)Loveland, Colorado, United StatesActive Not Recruiting
Delray Medical CenterDelray Beach, Florida, United StatesWithdrawn

+ 56 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT04153292