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

NCT05893082 | Completed DMC FDA Device

• 1 other identifier: AS01
• Study Type: interventional
• Target: 18
• 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. Participants will complete several neurocognitive assessments and an MRI procedure.

Conditions

Aortic Stenosis

Keywords

TAVR

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac and cerebrovascular events

  Major adverse cardiac and cerebrovascular events

  30 day

Secondary Outcomes (5)

• New lesions

  8 - 72 hours

• Performance

  Intra-procedure

• Modified Rankin Scale

  30 day

• National Institute of Health Stroke Scale

  30 day

• Montreal Cognitive Assessment

  30 day

Study Arms (1)

Intervention

EXPERIMENTAL

Placement of the F2 device in the aorta to cover the great cerebral vessels.

Device: F2 Filter and Delivery System

Interventions

F2 Filter and Delivery System DEVICE

Placement of F2 device in aorta to cover the great cerebral vessels.

Intervention

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.
• 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:

• 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).
• Patients with hypercoagulable states that cannot be corrected by additional periprocedural heparin.

Sponsors & Collaborators

• EnCompass Technologies, Inc.: lead

Study Sites (1)

North Shore Private

Sydney, New South Wales, 2065, Australia

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: May 23, 2023
• First Posted: June 7, 2023
• Study Start: September 12, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)