Actively Recruiting
Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Led by EnCompass Technologies, Inc. · Updated on 2025-02-25
10
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 22 years or older
- Meets criteria for commercially available transfemoral TAVR
- Montreal Cognitive Assessment score of 26 or higher at screening
- Willing and able to comply with follow-up evaluations
- Able and willing to provide written informed consent
You will not qualify if you...
- Contraindications to MRI including MR unsafe implants or claustrophobia
- Severe peripheral arterial, abdominal aortic, or thoracic aortic disease preventing device access or deployment
- Heavily calcified, severely atheromatous, or tortuous aortic arch
- Ascending aortic diameter greater than 38 mm or transverse aortic diameter greater than 27 mm
- Acute myocardial infarction within 1 month before TAVR
- Pre-existing prosthetic heart valve or ring
- Known intracardiac thrombus
- Severe allergies or contraindications to aspirin, heparin/bivalirudin, clopidogrel, nitinol, stainless steel, or contrast
- History of bleeding disorders or contraindicated for anti-platelet/anticoagulant therapy
- Refusal of blood transfusion
- Active peptic ulcer or recent upper GI bleeding within 3 months
- Recent stroke or transient ischemic attack within 6 months
- Renal insufficiency with creatinine over 2.5 mg/dL or GFR below 30, or on renal replacement therapy
- Hepatic failure (Child-Pugh class C)
- Uncorrectable hypercoagulable states
- Cardiogenic shock or need for vasopressor/inotropic support at procedure
- Severe ventricular dysfunction with LVEF below 20%
- Life expectancy less than 12 months
- Currently in another investigational drug or device study without completed primary endpoint
- Treatment with another investigational device within 30 days prior
- Planned surgery or invasive procedure within 30 days after TAVR with F2 filter
- Planned cardiac surgery or intervention during or within 10 days before TAVR except balloon valvuloplasty or diagnostic catheterization
- Known mental or physical illness or substance abuse affecting compliance or data
- Females who are pregnant, nursing, or planning pregnancy during study; females of childbearing potential must have negative pregnancy test
- Any other condition that poses significant hazard or precludes participation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Healthycore
Tbilisi, Georgia, 0112
Actively Recruiting
Research Team
K
Kathleen Calderon
CONTACT
F
Francis Duhay, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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