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The ENCIRCLE Trial — ENCIRCLE  

Mitral Regurgitation Clinical Trial

Official title:
SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access

Clinical Trial 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.

Clinical Trial Description

This is a prospective single-arm, multicenter study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04153292
Study type Interventional
Source Edwards Lifesciences
Contact Edwards THV Clinical Affairs
Phone +1 (949) 250-2500
Email THV_CT.gov@Edwards.com
Status Recruiting
Phase N/A
Start date November 12, 2020
Completion date February 2031
View Details
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Completed NCT01162083 - Identifying an Ideal Cardiopulmonary Exercise Test Parameter N/A
Suspended NCT00787293 - Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients Phase 2