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

NCT06689839 | Recruiting DMC FDA Device

• 1 other identifier: ET03
• Study Type: interventional
• Target: 500
• Locations: 2 countries
• Sites: 10

Brief 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)

Conditions

Aortic Stenosis Treated With TAVI; Aortic Diseases

Keywords

Embolic Protection; Transcatheter Aortic Valve Replacement; TAVR; Aortic Valve Stenosis; Aortic Valve Diseases

Outcome Measures

Primary Outcomes (2)

• Major Adverse Cardiac and Cerebrovascular Events (MACCE)

  MACCE includes the composite of death, all stroke, acute kidney injury (AKI) stage 3 or 4 within 7 days post-index procedure Valve Academic Research Consortium 3 (VARC-3) and any major vascular complication (VARC-3)

  30 days post procedure

• Total New Lesion Volume

  Total new lesion volume (TNLV) in the brain assessed by diffusion weighted magnetic resonance images (DW-MRI)

  8-72 hours post procedure

Secondary Outcomes (1)

• Stroke

  30 days post procedure

Other Outcomes (13)

• Performance

  During procedure

• Mortality & Stroke Rates

  30 days post procedure

• Freedom from Lesions

  8-72 hours post procedure

Study Arms (2)

F2 Filter and Delivery System

EXPERIMENTAL

The F2 Cerebral Embolic Protection System will be used during your Transcatheter Aortic Valve Replacement procedure

Device: F2 Filter and Delivery System; Procedure: Transcatheter Aortic Valve Replacement (TAVR)

Either the Sentinel Cerebral Protection System or no embolic protection device

ACTIVE COMPARATOR

Either the Sentinel Cerebral Protection System or no embolic protection device will be used during your Transcatheter Aortic Valve Replacement procedure depending on the Standard of Care at the treating institution

Procedure: Transcatheter Aortic Valve Replacement (TAVR)

Interventions

F2 Filter and Delivery System DEVICE

Use of the F2 Filter and Delivery System in conjunction with a Transcatheter Aortic Valve Replacement (TAVR) procedure

F2 Filter and Delivery System

Transcatheter Aortic Valve Replacement (TAVR) PROCEDURE

Transcatheter Aortic Valve Replacement (TAVR) with commercially available Transcatheter Aortic Valve Replacement (TAVR) device

Either the Sentinel Cerebral Protection System or no embolic protection device; F2 Filter and Delivery System

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 50 years.
• Patient meets the established criteria and indications for commercially available TAVR via transfemoral access and is scheduled to undergo TAVR per their treating physician.
• Patient is willing and able to comply with protocol-specified follow-up evaluations.
• Patient is able and willing to provide written informed consent.
• Patient meets all criteria for use of control device (Sentinel device, per IFU).

You may not qualify if:

• Patient requires an urgent or emergent TAVR procedure.
• Any interventional cardiovascular procedure performed within 30 days prior to TAVR procedure or planned within 30 days post-TAVR procedure.
• Diagnostic cardiac catheterization within 10 days prior to TAVR procedure.
• Evidence of an acute myocardial infarction within 3 months prior to TAVR procedure.
• Prior prosthetic heart valve in any position.
• Known intracardiac thrombus.
• Active infection or endocarditis.
• Patient is contraindicated for anti-platelet and/or anticoagulant therapy.
• Patient refuses blood transfusion.
• 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).
• Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 30%.
• Females who are pregnant or nursing or plan to become pregnant during their participation in the study.
• Modified Rankin Scale (mRS) ≥ 2 at screening.
• Cerebrovascular event including TIA within 6 months of the procedure.

Sponsors & Collaborators

• EnCompass Technologies, Inc.: lead
• Avania: collaborator
• Insight Medical Consulting: collaborator

Study Sites (10)

NCH Baker Hospital-Naples Heart Institute

Naples, Florida, 34102, United States

NOT YET RECRUITING

St. Vincent Hospital

Indianappolis, Indiana, 46260, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

St. Lukes Hospital Of Kansas City

Kansas City, Missouri, 64111, United States

RECRUITING

Cumc/Nyph

New York, New York, 10032, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Ohio Health Research Institute (aka Riverside Methodist Hospital)

Columbus, Ohio, 43214, United States

NOT YET RECRUITING

University of Virginia Medical Center

Charlottesville, Virginia, 22903, United States

NOT YET RECRUITING

St Andrews War Memorial Hospital

Spring Hill, Queensland, 4000, Australia

NOT YET RECRUITING

Monash Health Public

Clayton, Victoria, 3168, Australia

RECRUITING

MeSH Terms

Conditions

Aortic Diseases; Aortic Valve Stenosis; Aortic Valve Disease

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Heart Valve Diseases; Heart Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Central Study Contacts

Kathleen S Calderon

CONTACT

3072502726; kcalderon@encompassf2.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in 1:1 ratio to: * Transcatheter Aortic Valve Replacement (TF TAVR) with the F2 Cerebral Protection System (CPS) (treatment group) or * Transcatheter Aortic Valve Replacement (TF TAVR) with Standard of Care treatment (no embolic protection or use of the commercially available protection device, Sentinel System; control group)

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 15, 2024
• Study Start: September 9, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (8); AU (2)