Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-04 @ 4:41 AM
Study NCT ID:
NCT03997305
Status:
UNKNOWN
Last Update Posted:
2023-09-01
First Post:
2019-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AltaValve Early Feasibility Study Protocol
Sponsor:
4C Medical Technologies, Inc.
Organization:
Study Overview
Official Title:
AltaValve Early Feasibility Study Protocol
Status:
UNKNOWN
Status Verified Date:
2023-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prospective, single-arm, multicenter study to evaluate the safety and performance of the AltaValve for the treatment of moderate to severe or severe mitral valve regurgitation in subjects who are considered high risk for mortality and morbidity from conventional open-heart surgery.
Detailed Description:
None
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?: