F2 cerebral filter to protect the brain during transfemoral 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

This trial tests whether the F2 Cerebral Protection System is as safe and better than the standard Sentinel device at protecting the brain in people having transfemoral TAVR.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: EnCompass Technologies, Inc. (Industry-sponsored)
• Locations: 10 sites (Naples, Florida and 9 other locations)
• Trial ID: NCT06689839 on ClinicalTrials.gov

What this trial studies

This interventional comparison enrolls patients scheduled for transfemoral transcatheter aortic valve replacement and compares the F2 Cerebral Protection System (CPS) to a standard-of-care control device. The study is designed to show that the F2 CPS is non-inferior on safety while being superior on measures of effectiveness compared with the control. Participants undergo TAVR with either the F2 device or the control device per instructions for use, with procedural and post-procedural follow-up to capture adverse events and effectiveness endpoints. Outcomes likely include clinical safety events (such as device-related complications and stroke) and measures related to embolic protection, with follow-up visits at the enrolling centers.

Who should consider this trial

Good fit: Adults age 50 or older who are scheduled for transfemoral TAVR, can give informed consent, can comply with follow-up, and meet the control device's instructions-for-use criteria are appropriate candidates.

Not a fit: Patients needing urgent or emergent TAVR, with recent myocardial infarction, prior prosthetic heart valves, known intracardiac thrombus, active infection/endocarditis, or other exclusion criteria are not expected to benefit from participation.

Why it matters

Potential benefit: If successful, the F2 device could reduce the risk of stroke or silent brain injury during transfemoral TAVR by capturing embolic debris.

How similar studies have performed: Other cerebral protection devices like Sentinel have consistently captured embolic debris and reduced some MRI-detected lesions in prior studies, but consistent reduction in clinical stroke rates has not been conclusively shown.

Eligibility criteria

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.

Where this trial is running

Naples, Florida and 9 other locations

• NCH Baker Hospital-Naples Heart Institute — Naples, Florida, United States (Not_yet_recruiting)
• St. Vincent Hospital — Indianappolis, Indiana, United States (Recruiting)
• Henry Ford Hospital — Detroit, Michigan, United States (Recruiting)
• St. Lukes Hospital Of Kansas City — Kansas City, Missouri, United States (Recruiting)
• Cumc/Nyph — New York, New York, United States (Recruiting)
• Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
• Ohio Health Research Institute (aka Riverside Methodist Hospital) — Columbus, Ohio, United States (Not_yet_recruiting)
• University of Virginia Medical Center — Charlottesville, Virginia, United States (Not_yet_recruiting)
• St Andrews War Memorial Hospital — Spring Hill, Queensland, Australia (Not_yet_recruiting)
• Monash Health Public — Clayton, Victoria, Australia (Recruiting)

Study contacts

• Study coordinator: Kathleen S Calderon

Conditions Aortic Stenosis Treated With TAVI; Aortic Diseases; Embolic Protection; Transcatheter Aortic Valve Replacement; TAVR; Aortic Valve Stenosis; Aortic Valve Diseases