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

Not Applicable

Not yet recruiting

• Conditions: Aortic Stenosis Treated With TAVI; Aortic Diseases

• Registration Number: NCT06689839
• Lead Sponsor: EnCompass Technologies, Inc.

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)

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).

Study Timeline

• Study First Submitted: 2024-11-01
• Study First Submitted QC: 2024-11-08
• Study First Posted: 2024-11-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Study Start: 2025-03-01
• Primary Completion: 2026-07
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac and Cerebrovascular Events (MACCE)	30 days post procedure	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)
Total New Lesion Volume	8-72 hours post procedure	Total new lesion volume (TNLV) in the brain assessed by diffusion weighted magnetic resonance images (DW-MRI)

Secondary Outcome Measures

Name	Time	Method
Stroke	30 days post procedure	Incidence of all stroke events

Trial Locations

Locations (5)

St. Vincent Hospital; 🇺🇸 Indianapolis, 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

Ohio Health Research Institute (aka Riverside Methodist Hospital); 🇺🇸 Columbus, Ohio, United States