U.S. Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR

Study Overview
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Brief Summary
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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 undergoing a Transcatheter Aortic Valve replacement procedure.

Detailed Description
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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 undergoing 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.

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

Conditions
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Aortic Stenosis

Intervention / Treatment
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* Device: Aortic Stenosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 22 years. The patient meets the established criteria and indications for commercially available TAVR (Edwards/Medtronic) for transfemoral access. Modified Rankin Scale (mRS) 0 or 1 at screening. Montreal Cognitive Assessment (MoCA) score ≥ 26 at screening. The patient is willing and able to comply with protocol-specified follow-up evaluations. 6 The patient or legally authorized representative is able and willing to provide written informed consent. Exclusion Criteria: Subjects are not eligible for the study if any of the following criteria are present: 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). Severe peripheral arterial, abdominal aortic, or thoracic aortic disease that precludes delivery sheath vascular access or filter deployment. Patients in whom the aortic arch is heavily calcified, severely atheromatous, or severely tortuous. Ascending aortic diameter > 38 mm or transverse aortic diameter > 27 mm. Evidence of an acute myocardial infarction within 1 month before TAVR. Pre-existing prosthetic heart valve or prosthetic ring in any position. Known intracardiac thrombus. 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. History of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated. Patients who refuse blood transfusion. Active peptic ulcer or history of upper gastrointestinal (GI) bleeding within the prior 3 months. Recent (within 6 months) CVA or a TIA. 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). Patients with hypercoagulable states that cannot be corrected by additional periprocedural heparin. Patients presenting with cardiogenic shock or requiring vasopressor or inotropic support at the time of the index procedure. Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20%. Life expectancy < 12 months. 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). Subjects who have had treatment with any other investigational device within 30 days prior to study enrollment. Planned surgery or invasive procedure within 30 days following the index procedure (TAVR with F2 Filter). 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. 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. 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. Any other condition that in the opinion of the investigator, precludes study participation or poses a significant hazard to the patient.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-Arm<br>Device: F2 Filter and Delivery System | Device: Aortic Stenosis<br>* F2 Filter and Delivery system to cover the 3 great cerebral vessels<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac and cerebrovascular events (MACCE) | Major adverse cardiac and cerebrovascular events | 30 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total new lesion volume | Total new lesion volume | 8-72 hours | 
| Average Individual new Lesion volume | Average individual new lesion volume | 8-72 hours | 
| Number of new Lesions | Number of Lesions | 8-72 hours | 
| Location of new Lesions | Location of Lesions | 8-72 hours | 
| Territory of new Lesions | Territory of Lesions | 8-72 hours | 
| Performance | Technical success (% of patients with successful device deployment, position and retrieval) and procedure success (% of patients with technical device success and no device-related safety events) | Intra-procedure | 
| Modified Rankin Score | Measures neurological disability on a scale of 0-6 (low score is better outcome) | 30 day | 
| National Institute of Health Stroke Scale (NIHSS) | Measures stroke severity on a scale of 0-42 (low score is better outcome) | 30 day | 
| Montreal Cognitive Assessment | Measures cognitive impairment on a scale of 0-30 (high score is better outcome) | 30 day |