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Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT06689839•EnCompass Technologies, Inc.

View on ClinicalTrials.gov

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).

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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).

Exclusion Criteria

•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.
+15 more criteria

Locations (10)

NCH Baker Hospital-Naples Heart Institute

Naples, Florida, United States

St. Vincent Hospital

Indianappolis, Indiana, United States

Henry Ford Hospital

Detroit, Michigan, United States

St. Lukes Hospital Of Kansas City

Kansas City, Missouri, United States

Cumc/Nyph

New York, New York, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio Health Research Institute (aka Riverside Methodist Hospital)

Columbus, Ohio, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

St Andrews War Memorial Hospital

Spring Hill, Queensland, Australia

Monash Health Public

Clayton, Victoria, Australia

Key Dates

Start Date

September 9, 2025

Primary Completion Date

December 1, 2026

Completion Date

January 1, 2027

Last Updated

November 20, 2025

Enrollment

500

ESTIMATED participants

Conditions

Aortic Stenosis Treated With TAVIAortic Diseases

Interventions

F2 Filter and Delivery System

DEVICE

Transcatheter Aortic Valve Replacement (TAVR)

PROCEDURE

Contacts

Kathleen S Calderon

CONTACT

3072502726 kcalderon@encompassf2.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Intervascular Post-Market Clinical Follow-Up (PMCF) Registry

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