NCT06689839

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

A Prospective, Randomized, Multicenter, Single-blind Trial to Assess the Safety and Effectiveness of the Encompass F2 Cerebral Protection System Vs. Standard of Care (Unprotected or Sentinel® Cerebral Protection System) During Transfemoral Transcatheter Aortic Valve Replacement

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: EnCompass Technologies, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to compare the safety and effectiveness of the F2 Cerebral Protection System (CPS) to a standard of care control group in patients undergoing Transcatheter Aortic Valve Replacement (TF TAVR)

Detailed description

The study is designed to demonstrate that the F2 Cerebral Protection System (CPS) performs in a consistent manner as the control group in terms of safety, and the F2 Cerebral Protection System (CPS) will be superior in performance when compared to the control group in terms of effectiveness in patients undergoing Transcatheter Aortic Valve Replacement (TF TAVR).

Conditions

• Aortic Stenosis Treated With TAVI
• Aortic Diseases

Interventions

Type	Name	Description
DEVICE	F2 Filter and Delivery System	Use of the F2 Filter and Delivery System in conjunction with a Transcatheter Aortic Valve Replacement (TAVR) procedure
PROCEDURE	Transcatheter Aortic Valve Replacement (TAVR)	Transcatheter Aortic Valve Replacement (TAVR) with commercially available Transcatheter Aortic Valve Replacement (TAVR) device

Timeline

• Start date: 2025-09-09
• Primary completion: 2026-12-01
• Completion: 2027-01-01
• First posted: 2024-11-15
• Last updated: 2025-11-20

Locations

10 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated device study