Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-26 @ 1:20 AM
Study NCT ID:
NCT07188233
Status:
RECRUITING
Last Update Posted:
2025-09-23
First Post:
2025-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With FMR
Sponsor:
HVR Cardio Oy
Organization:
Study Overview
Official Title:
A Study to Evaluate the Feasibility and Safety of Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With Functional Mitral Regurgitation
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:
MARCH
Brief Summary:
Patients with functional mitral regurgitation classified as moderate to severe (3+) or severe (4+) that are symptomatic (NYHA Class II-IV) will be evaluated for treatment using the CathHELIX Transcatheter Mitral Annuloplasty System.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: