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Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR

Aortic Stenosis Clinical Trial

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

Clinical Trial 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. Participants will complete several neurocognitive assessments and an MRI procedure.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05893082
Study type Interventional
Source EnCompass Technologies, Inc.
Contact Kathleen Calderon
Phone 307-250-2726
Email kcalderon@encompassf2.com
Status Recruiting
Phase N/A
Start date September 12, 2023
Completion date January 2024
View Details
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