Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-01-04 @ 2:27 PM
Study NCT ID:
NCT04153292
Status:
RECRUITING
Last Update Posted:
2025-11-26
First Post:
2019-11-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The ENCIRCLE Trial
Sponsor:
Edwards Lifesciences
Organization:
Study Overview
Official Title:
SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENCIRCLE
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: