Recruiting

F2 CPS vs. Standard CareTrial of the F2 Filter and Delivery System for Embolic Protection During TAVR

Sponsor:

EnCompass Technologies, Inc.

Code:

NCT06689839

Conditions

Aortic Stenosis Treated With TAVI

Aortic Diseases

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

F2 Filter and Delivery System

Transcatheter Aortic Valve Replacement (TAVR)

Study Details

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

Study ID

NCT06689839

Start date

Sep 9, 2025

Status verified date

Nov, 2025

Completion date

Jan, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Key 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).

Key Exclusion Criteria:

General 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.
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.

Neurological Exclusion Criteria:

Modified Rankin Scale (mRS) ≥ 2 at screening.
Cerebrovascular event including TIA within 6 months of the procedure.
Patient has active major psychiatric disease, known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol or confound the data interpretation.
Patient has severe visual, auditory, or learning impairment.
Patient has neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.

Magnetic Resonance Imaging Exclusion Criteria:

Contraindications to MRI (participants 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).
High risk of complete AV block after TAVR, with the need of permanent pacemaker.
Claustrophobia precluding MRI scanning.

Anatomical and CT Exclusion Criteria:

Severe peripheral arterial, abdominal aortic, or thoracic aortic disease that precludes delivery sheath, vascular access or filter deployment.
Presence of cardiovascular implant in aorta and/or peripheral access vessels.
Access vessels with excessive tortuosity.
Aortic arch, which is heavily calcified, severely atheromatous, or severely tortuous.

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: F2 Filter and Delivery System

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

active comparator: Either the Sentinel Cerebral Protection System or no embolic protection device

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

Interventions

F2 Filter and Delivery System

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

Transcatheter Aortic Valve Replacement (TAVR)

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

Primary outcome measure

Major Adverse Cardiac and Cerebrovascular Events (MACCE) [ Time Frame: 30 days post procedure ]
Total New Lesion Volume [ Time Frame: 8-72 hours post procedure ]

Central Contacts and Locations

Central contacts

Kathleen S Calderon

3072502726 kcalderon@encompassf2.com

Locations

St. Vincent Hospital

Recruiting

Indianappolis, Indiana, United States, 46260

Contacts

Kelly Verel

317-338-8042 kelly.verel@ascension.org

Principal Investigator:

James Hermiller, MD

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Stephen Krafchak

313-972-4018 skrafch1@hfhs.org

Sara Poggio, RN

313-916-0119 spoggio1@hfhs.org

Principal Investigator:

Brian O'Neill, MD

St. Lukes Hospital Of Kansas City

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Caroline Kempter

ckempter@saint-lukes.org

Anne Hoffman

816-932-5707 ahoffman@saint-lukes.org

Cumc/Nyph

Recruiting

New York, New York, United States, 10032

Contacts

Kate Dalton

212-342-1820 keb2114@columbia.edu

Treena Williams

taw2112@columbia.edu

Principal Investigator:

Torsten Vahl, MD

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Emily Tylicki

216-287-8237 TYLICKE@ccf.org

Principal Investigator:

Amar Krishnaswamy, MD

More Information

Sponsor

EnCompass Technologies, Inc.

Last update posted

Nov 20, 2025

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by EnCompass Technologies, Inc. on 2025-11-20.