NCT04153292

The ENCIRCLE Trial

SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective single-arm, multicenter study.

Conditions

• Mitral Regurgitation
• Mitral Valve Insufficiency

Interventions

Type	Name	Description
DEVICE	SAPIEN M3 valve and dock	During the procedure a SAPIEN M3 dock and a SAPIEN M3 valve will be implanted via transseptal approach.

Timeline

• Start date: 2020-11-12
• Primary completion: 2027-02-28
• Completion: 2031-02-28
• First posted: 2019-11-06
• Last updated: 2026-02-25

Locations

68 sites across 6 countries: United States, Australia, Canada, Israel, Netherlands, United Kingdom

Regulatory

• FDA-regulated device study