Ignite Creation Date:
2025-12-18 @ 9:17 AM
Ignite Modification Date:
2025-12-23 @ 8:39 PM
Study NCT ID:
NCT05866640
Status:
None
Last Update Posted:
2025-02-25 00:00:00
First Post:
2023-05-08 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Sponsor:
None
Organization:
Study Overview
Official Title:
A Prospective, Single-Arm, Single Center Feasibility Trial to Evaluate the Safety and Performance of the F2 Filter and Delivery System Used for Embolic Protection During Transcatheter Aortic Valve Replacement
Status:
None
Status Verified Date:
2025-02
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:
The goal of this clinical trial is to learn about the safety and performance of the F2 device for cerebral embolic protection in participants with symptomatic aortic stenosis underdoing a transcatheter aortic valve replacement procedure. The F2 device is inserted via a transfemoral approach and positioned in the aorta to cover and protect the three great cerebral vessels from any debris released during the valve replacement procedure. The F2 device remains in place during the aortic valve replacement procedure. After the valve is placed, the F2 device is removed.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: