Ignite Creation Date:
2024-05-06 @ 2:55 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04464876
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2020-06-24
Brief Title:
SATURN Transcatheter Mitral Valve Replacement for Functional Mitral Regurgitation
Sponsor:
InnovHeart
Organization:
InnovHeart
Study Overview
Official Title:
SATURN Transcatheter Mitral Valve Replacement for Functional Mitral Regurgitation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
None
Brief Summary:
This study is a prospective single-arm multi-center feasibility clinical study of the SATURN TA System for the treatment of NYHA Class II patients with severe functional mitral regurgitation who are not suitable for surgical treatment following Heart Team assessment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None