Ignite Creation Date:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2026-02-17 @ 5:46 PM
Study NCT ID:
NCT04098328
Status:
TERMINATED
Last Update Posted:
2023-12-18
First Post:
2019-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Feasibility EXperience of Posterior Leaflet RestOration to REduce Mitral Regurgitation
Sponsor:
Polares Medical SA
Organization:
Study Overview
Official Title:
Early Feasibility EXperience of Posterior Leaflet RestOration to REduce Mitral Regurgitation (EXPLORE MR)
Status:
TERMINATED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study device refinement
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXPLORE MR
Brief Summary:
Early feasibility study, single-arm registry design
Detailed Description:
First-In-Human
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: