Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-26 @ 9:59 AM
Study NCT ID:
NCT05682066
Status:
COMPLETED
Last Update Posted:
2025-04-23
First Post:
2022-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TVMR With the Innovalve System Trial - Pilot in Georgia
Sponsor:
Edwards Lifesciences
Organization:
Study Overview
Official Title:
TVMR With the Innovalve System Trial - Pilot in Georgia
Status:
COMPLETED
Status Verified Date:
2025-04
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:
TWIST-PILOT-GE
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 pilot study to evaluate the safety and performance of the Innovalve mitral valve replacement system
Study Oversight
Has Oversight DMC:
True
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?: