NCT05893082

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

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: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: EnCompass Technologies, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	F2 Filter and Delivery System	Placement of F2 device in aorta to cover the great cerebral vessels.

Timeline

• Start date: 2023-09-12
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2023-06-07
• Last updated: 2025-02-17

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated device study