The CAPTIS® Study - Embolic Protection in TAVR

Study Overview
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Brief Summary
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This is a First in Human study with the Filerlex CAPTIS device designed to demonstrate the safety and feasibility of the device in subjects undergoing Transcatheter Aortic Valve Replacement (TAVR)

Detailed Description
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This is a prospective, multi center, single arm, FIH safety and feasibility study enrolling up to 20 patients. Patients undergoing clinically indicated TAVR who comply with the study inclusion/exclusion criteria will be enrolled to have embolic protection with the CAPTIS® Device during the TAVR procedure. Screening activities will include initial screening by the site, analysis of patient CT scan by the sponsor and core-lab, and review of the clinical and imaging data by an eligibility committee to confirm that all inclusion/exclusion criteria are met. Final eligibility for study enrollment is then determined by the investigator in the cardiac catheterization laboratory. Enrolled patients will undergo safety assessment during the procedure, post-procedure, and at 30 days post-procedure; Feasibility evaluation will be assessed during procedure.

Official Title
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A Prospective, Single Arm, FIH Study to Evaluate the Safety and Feasibility of the CAPTIS Device in Patients Undergoing Transcatheter Aortic Valve Replacement (TAVR)

Conditions
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Transcatheter Aortic Valve Replacement

Intervention / Treatment
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* Device: CAPTIS Embolic Protection device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must be ≥18 years of age. Patient has clinical indications for TAVR procedure. TAVR procedure planned with femoral artery access site TAVR device approved for use in the US, Europe or Israel Femoral and iliac artery with a minimal luminal diameter of at least 6 mm Descending Aorta diameter of 20 to 27mm measured 10cm from the left subclavian, determined by CT scan analysis The distance between the innominate and left-subclavian arteries (including their lumens) is less than 65mm Patient is willing to comply with protocol-specified preprocedure and follow-up evaluations. The patient has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the ethics committee of the clinical site. Exclusion Criteria: General Pregnant or nursing female patients. Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to surgical procedure per site standard test Hemodialysis shunt, graft, or arterio-venous fistula involving the lower extremity vasculature Blood dyscrasias: WBC <5000/microliter, Hb <10.0 mg/dL, PLT <100,000/microliter, history of bleeding diathesis, coagulopathy, or conditions associated with increased thrombogenicity Hemodynamic instability requiring pharmacological or mechanical circulatory support. Patient in whom hemodynamic instability is expected or at increased risk, will also be excluded. Any surgery or procedure (including endovascular) planned for the 30 days post TAVR Severe left-ventricle dysfunction with LVEF ≤30% Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation Active or recent bacterial endocarditis Active peptic ulcer or upper GI bleeding within the prior 3 months A known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, clopidogrel, ticagrelor, or contrast media, which cannot be adequately pre-medicated or replaced by an alternative agent Renal insufficiency (GFR < 30). Patients on renal replacement therapy (dialysis) can be enrolled into the study. Life expectancy < 12 months due to non-cardiac comorbid conditions Patients who refuse blood transfusion Chronic or persistent atrial fibrillation, frequent recurring atrial fibrillation, and patients with planned ablation for atrial fibrillation Currently participating in another investigational drug or device study Patient is otherwise not appropriate for the study as determined by the investigator or the Eligibility Committee Neurologic Prior CVA or a TIA Patient has undergone carotid stenting or carotid endarterectomy within the previous 6 months Patient has active major psychiatric disease that prevent a conscious consent Patient with neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic deficit or known structural brain abnormalities Vascular Severe tortuosity or luminal diameter of less than 6 mm of the femoral or iliac arteries Excessive tortuosity or calcification or atherosclerosis of any segment of the aorta and iliac arteries Patient whose innominate, carotid, or subclavian arteries reveals significant stenosis, ostial calcification, ectasia, dissection, or aneurysm at the ostium

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAPTIS Embolic Protection<br>TAVR will be performed according to standard institutional practice under local or general anesthesia by the transfemoral approach. The investigational device will be advanced and deployed across the aortic arch covering the ostia of the 3 great vessels (innominate, left carotid, and left-subclavian arteries) at the initiation of the procedure and withdrawn at the completion of the TAVR procedure. | Device: CAPTIS Embolic Protection device<br>* The CAPTIS Embolic Protection device will be deployed during standard of care TAVR procedure. The device's safety will be assessed up to one month post procedure. The device's technical performance and feasibility to capture and remove debris during the procedure will be evaluated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Occurrence of MACCE | Occurrence of all MACCE at 72 hours post procedure, with MACCE defined as all death and all cerebrovascular events (all TIA and stroke). | 72 hours | 
| Safety - Device related complications | Number of device related complications [at 72 hours] | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Safety - Occurrence of MACCE | All MACCE, number of stroke events, number of TIA events [at 30 days] | 30 days | 
| Secondary Safety - Acute Kidney Injury | Number of subjects with acute kidney injury (defined as increase in creatinine level of 25% or 0.5mg/dL at 72 hours (or discharge) as compared to pre-procedure baseline) | 72 hours | 
| Device feasibility - Histopathologic examination of debris captured and removed by the device | All devices will be sent for histopathologic examination to determine the device's feasibility to catch and remove debris during the TAVR procedure | Day 0 | 
| Technical Device Performance - the ability to deploy and retrieve the device without device malfunction | Number of procedures performed without device malfunction | Day 0 |