The ENCIRCLE Trial
SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access
Edwards Lifesciences
900 participants
Nov 12, 2020
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
During the procedure a SAPIEN M3 dock and a SAPIEN M3 valve will be implanted via transseptal approach.
Locations(68)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04153292