Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-04-17 @ 4:21 PM
Study NCT ID:
NCT05526560
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-29
First Post:
2022-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve
Sponsor:
Edwards Lifesciences
Organization:
Study Overview
Official Title:
A Prospective, Global Study Designed to Collect Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
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:
MOMENTIS
Brief Summary:
Collect real-world data on acute and long-term safety and performance of the MITRIS RESILIA Mitral Valve, Model 11400M, in subjects requiring replacement of their native or prosthetic mitral valve with or without concomitant procedures.
Detailed Description:
MOMENTIS is a prospective, observational, single-arm, multicenter global study designed to collect real-world clinical outcomes in up to 500 subjects who have received the MITRIS RESILIA Mitral Valve, Model 11400M.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: