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

NCT06069661 | Withdrawn DMC FDA Device

• 1 other identifier: ET02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac and cerebrovascular events (MACCE)

  Major adverse cardiac and cerebrovascular events

  30 day

Secondary Outcomes (9)

• Total new lesion volume

  8-72 hours

• Average Individual new Lesion volume

  8-72 hours

• Number of new Lesions

  8-72 hours

• Location of new Lesions

  8-72 hours

• Territory of new Lesions

  8-72 hours

Study Arms (1)

Single-Arm

EXPERIMENTAL

Device: F2 Filter and Delivery System

Device: Aortic Stenosis

Interventions

Aortic Stenosis DEVICE

F2 Filter and Delivery system to cover the 3 great cerebral vessels

Single-Arm

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The patient or legally authorized representative is able and willing to provide written informed consent.

You may not qualify if:

• 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.
• Patients who refuse blood transfusion.
• Active peptic ulcer or history of upper gastrointestinal (GI) bleeding within the prior 3 months.
• Recent (within 6 months) CVA or a TIA.
• Renal insufficiency (creatinine \> 2.5 mg/dL or GFR \< 30) and/or renal replacement therapy at the time of screening.
• Patients with hepatic failure (Child-Pugh class C).

Sponsors & Collaborators

• EnCompass Technologies, Inc.: lead

Study Sites (1)

New York Presbyterian/Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Francis Duhay, MD

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 6, 2023
• Study Start: June 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)