Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400342
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-03-25
Brief Title:
Randomized Evaluation for Failed TAVR
Sponsor:
Medstar Health Research Institute
Organization:
Medstar Health Research Institute
Study Overview
Official Title:
Randomized Evaluation of Valve-In-Valve Versus Explantation for Failed TAVR REVIVE-TAVR
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
REVIVE-TAVR
Brief Summary:
REVIVE TAVR is an acronym for the Randomized Evaluation of Valve-In-Valve versus Explantation for failed TAVR This is a prospective multicenter global randomized trial investigating the safety and efficacy of reintervention for transcatheter heart valve THV failure by comparing redo-TAVR TAV-in-TAV with TAVR surgical explantation TAVR-explant in subjects who are suitable for both options in a real-world clinical setting
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
True
Is an FDA AA801 Violation?:
None