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

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

The goal of this clinical trial is to learn about the safety and performance of the F2 device for cerebral embolic protection in participants with symptomatic aortic stenosis underdoing a Transcatheter Aortic Valve replacement procedure.

Participants will complete several neurocognitive assessments and an MRI procedure.

Study Overview

• Status: Recruiting
• Conditions: Aortic Stenosis
• Intervention / Treatment: Device: F2 filter and delivery system

Detailed Description

The goal of this clinical trial is to learn about the safety and performance of the F2 device for cerebral embolic protection in participants with symptomatic aortic stenosis underdoing a transcatheter aortic valve replacement procedure. The F2 device is inserted via a transfemoral approach and positioned in the aorta to cover and protect the three great cerebral vessels from any debris released during the valve replacement procedure. The F2 device remains in place during the aortic valve replacement procedure. After the valve is placed, the F2 device is removed.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Kathleen Calderon; Phone Number: 307-250-2726; Email: kcalderon@encompassf2.com
• Study Contact Backup: Name: Francis Duhay, MD; Phone Number: 949-285-8170; Email: FDuhay@encompassf2.com

Study Locations

• Georgia
  • Tbilisi, Georgia, 0112
    • Recruiting
    • Healthycore
    • Principal Investigator: Irakli Gogorishvili, MD
    • Contact: Irakli Gogorishvili, MD; Phone Number: +995322433343; Email: Gogorishvili@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Placement of the F2 device in the aorta to cover the great cerebral vessels.	Device: F2 filter and delivery system; Placement of F2 device in aorta to cover great cerebral vessels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiac and cerebrovascular events	Major adverse cardiac and cerebrovascular events	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New lesions	total new lesion volume, average individual new lesion volume, number of new lesions, location of new lesions, territory of new lesions	8-72 hours
Performance	technical success (% of patients with successful device deployment, position and retreival and procedure success (% of patients with technical device success and no device-related safety events)	intra-procedure
Modified Rankin Scale	Measures neurological disability on scale of 0-6 (low score is better outcome)	30 day
National Institute of Health Stroke Scale	Measures stroke severity on scale of 0 - 42 (low score is better outcome)	30 day
Montreal Cognitive Assessment	Measures cognitive impairment on scale of 0 - 30 (high score is better outcome)	30 day

Collaborators and Investigators

• Sponsor: EnCompass Technologies, Inc.
• Investigators: Study Director: Francis Duhay, MD, Sponsor GmbH

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2023
• Primary Completion (Estimated): January 30, 2024
• Study Completion (Estimated): January 30, 2024

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: May 17, 2023
• First Posted (Actual): May 19, 2023

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: TAVR
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: RG01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes