Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-02-24 @ 3:13 PM
Study NCT ID:
NCT04149535
Status:
COMPLETED
Last Update Posted:
2023-02-02
First Post:
2019-10-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter
Status:
COMPLETED
Status Verified Date:
2023-01
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:
PROTECTED TAVR
Brief Summary:
To demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
True
Is an FDA AA801 Violation?: