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

EnCompass Technologies, Inc.1 site in 1 country25 target enrollmentJune 2024

ConditionsAortic Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Stenosis
Sponsor: EnCompass Technologies, Inc.
Enrollment: 25
Locations: 1
Primary Endpoint: Major adverse cardiac and cerebrovascular events (MACCE)
Status: Withdrawn
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 2024

End Date

January 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

EnCompass Technologies, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 22 years.
•The patient meets the established criteria and indications for commercially available TAVR (Edwards/Medtronic) for transfemoral access.
•Modified Rankin Scale (mRS) 0 or 1 at screening.
•Montreal Cognitive Assessment (MoCA) score ≥ 26 at screening.
•The patient is willing and able to comply with protocol-specified follow-up evaluations.
•6 The patient or legally authorized representative is able and willing to provide written informed consent.

Exclusion Criteria

•Subjects are not eligible for the study if any of the following criteria are present:
•Contraindications to MRI (e.g., subjects with MR unsafe implants including implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVR procedure, or claustrophobia).
•Severe peripheral arterial, abdominal aortic, or thoracic aortic disease that precludes delivery sheath vascular access or filter deployment.
•Patients in whom the aortic arch is heavily calcified, severely atheromatous, or severely tortuous.
•Ascending aortic diameter \> 38 mm or transverse aortic diameter \> 27 mm.
•Evidence of an acute myocardial infarction within 1 month before TAVR.
•Pre-existing prosthetic heart valve or prosthetic ring in any position.
•Known intracardiac thrombus.
•Severe allergy or known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel, nitinol, stainless steel alloy, and/or contrast sensitivity that cannot be adequately pre-medicated.
•History of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated.