Using the F2 device to protect the brain during heart valve replacement

A Prospective, Single-Arm, Single Center Feasibility Trial to Evaluate the Safety and Performance of the F2 Filter and Delivery System Used for Embolic Protection During Transcatheter Aortic Valve Replacement

This study is testing if a new device can help protect the brain from debris during heart valve replacement surgery for people with aortic stenosis.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: EnCompass Technologies, Inc. (industry)
• Locations: 1 site (Tbilisi)
• Trial ID: NCT05866640 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of the F2 filter and delivery system, which is designed to protect the brain from debris during a Transcatheter Aortic Valve Replacement (TAVR) procedure in patients with symptomatic aortic stenosis. The F2 device is inserted through the femoral artery and positioned in the aorta to shield the major cerebral vessels during the valve replacement. Participants will undergo neurocognitive assessments and MRI scans to monitor their cognitive function and ensure the device's safety. The study will help determine if this device can reduce the risk of cerebral embolic events during TAVR.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 22 and older who are eligible for TAVR and have a satisfactory cognitive assessment score.

Not a fit: Patients with contraindications to MRI or severe vascular diseases that prevent access for the device may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of cognitive decline and other complications associated with TAVR procedures.

How similar studies have performed: While similar approaches have been explored, the use of the F2 device specifically for cerebral protection during TAVR is a novel application.

Eligibility criteria

Inclusion Criteria:

criteria:

1. Age ≥ 22 years.
2. The patient meets the established criteria and indications for commercially available TAVR (Edwards/Medtronic) for transfemoral access.
3. Montreal Cognitive Assessment (MoCA) score ≥ 26 at screening.
4. The patient is willing and able to comply with protocol-specified follow-up evaluations.
5. The patient or legally authorized representative is able and willing to provide written informed consent.

Exclusion Criteria:

1. Contraindications to MRI (e.g., subjects 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, or claustrophobia).
2. Severe peripheral arterial, abdominal aortic, or thoracic aortic disease that precludes delivery sheath vascular access or filter deployment.
3. Patients in whom the aortic arch is heavily calcified, severely atheromatous, or severely tortuous.
4. Ascending aortic diameter \> 38 mm or transverse aortic diameter \> 27 mm.
5. Evidence of an acute myocardial infarction within 1 month before TAVR.
6. Pre-existing prosthetic heart valve or prosthetic ring in any position.
7. Known intracardiac thrombus.
8. Severe allergy or known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel, nitinol, stainless steel alloy, and/or contrast sensitivity that cannot be adequately pre-medicated.
9. History of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated.
10. Patients who refuse blood transfusion.
11. Active peptic ulcer or history of upper gastrointestinal (GI) bleeding within the prior 3 months.
12. Recent (within 6 months) CVA or a TIA.
13. Renal insufficiency (creatinine \> 2.5 mg/dL or GFR \< 30) and/or renal replacement therapy at the time of screening.
14. Patients with hepatic failure (Child-Pugh class C).
15. Patients with hypercoagulable states that cannot be corrected by additional periprocedural heparin.
16. Patients presenting with cardiogenic shock or requiring vasopressor or inotropic support at the time of the index procedure.
17. Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 20%.
18. Life expectancy \< 12 months.
19. Currently participating in an investigational drug or another device study that has not completed the initial primary endpoint evaluation (e.g., long term follow-up study/continued access study subjects are able to be included).
20. Subjects who have had treatment with any other investigational device within 30 days prior to study enrollment.
21. Planned surgery or invasive procedure within 30 days following the index procedure (TAVR with F2 Filter).
22. Patients planned to undergo any other cardiac surgical or interventional procedure (e.g., concurrent coronary revascularization) during the TAVR procedure or within 10 days prior to the TAVR procedure. NOTE: Balloon valvuloplasty during TAVR is permitted. Diagnostic cardiac catheterization is permitted within 10 days prior to the TAVR procedure.
23. Patients with known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol or confound the data interpretation.
24. Females who are pregnant or nursing or plan to become pregnant during their participation in the study. Female subjects of child-bearing potential must have a negative pregnancy test at screening.
25. Any other condition that in the opinion of the investigator, precludes study participation or poses a significant hazard to the patient.

    \-

Where this trial is running

Tbilisi

• Healthycore — Tbilisi, Georgia (RECRUITING)

Study contacts

• Study coordinator: Kathleen Calderon

Conditions: Aortic Stenosis, TAVR