Clinical Trial

The ENCIRCLE Trial

Study acronym: ENCIRCLE
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 35 amendments
This ClinicalTrials.gov record has been amended 35 times since 2019-11-05; most recent amendment 2026-02-23.
Status change: Withheld → Recruiting 2021-02-12
Status change: Not Yet Recruiting → Withheld 2019-11-07
Trial Details
NCT Number NCT04153292
Lead Sponsor Edwards Lifesciences
Conditions Mitral Regurgitation, Mitral Valve Insufficiency
Enrollment 900 participants
Start Date 2020-11-12
Primary Completion 2027-02-28 (estimated)
Study Completion 2031-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-02-25