Ignite Creation Date:
2024-05-06 @ 4:13 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04919980
Status:
RECRUITING
Last Update Posted:
2023-11-28
First Post:
2021-06-03
Brief Title:
TVMR With the Innovalve System Trial - Early Feasibility Study
Sponsor:
Innovalve Bio Medical Ltd
Organization:
Innovalve Bio Medical Ltd
Study Overview
Official Title:
TVMR With the Innovalve System Trial - Early Feasibility Study
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
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:
TWIST-EFS
Brief Summary:
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system
Detailed Description:
The study is a multi-center First-In-Human prospective single arm early feasibility study to evaluate the safety and performance of the Innovalve mitral valve replacement system
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None