Ignite Creation Date:
2025-12-24 @ 12:57 PM
Ignite Modification Date:
2026-02-20 @ 1:35 PM
Study NCT ID:
NCT06069661
Status:
WITHDRAWN
Last Update Posted:
2025-02-25
First Post:
2023-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
U.S. Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Sponsor:
EnCompass Technologies, Inc.
Organization:
Study Overview
Official Title:
A Prospective, Single-arm, Multicenter 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:
WITHDRAWN
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
moving directly into the Pivotal study
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 undergoing a Transcatheter Aortic Valve replacement procedure.
Detailed Description:
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 undergoing 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.
Study Oversight
Has Oversight DMC:
True
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?: