NAUTILUS CE-mark Trial of the FLOWer Cerebral Embolic Protection Device

Study Overview
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Brief Summary
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The purpose of this clinical study is to assess the safety, performance, and treatment effect of the use of the AorticLab FLOWer System, in preventing cerebral thromboembolic complications in patients with indication for a TAVI (Transcatheter Aortic Valve Implant).

Detailed Description
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A single arm, prospective, multicenter non-randomized clinical study of the AorticLab FLOWer System to prevent embolic complications during transcatheter aortic valve procedures.

Official Title
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Clinical Study of a Novel Transcatheter Anti-embolic Filter (FLOWer) for Cerebral Protection During Aortic Valve Interventions

Conditions
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Aortic Valve Stenosis, Intracranial Embolism and Thrombosis

Intervention / Treatment
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* Procedure: TAVI (Transcatheter Aortic Valve Implant)
* Device: FLOWer Embolic Protection System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects of age ≥ 18 years Subject is scheduled to undergo transfemoral aortic valve implant (TAVI) procedure on a stenotic native aortic valve and is qualified based on pre-operative CT-scan examination (trans-thoracic echocardiogram (TTE) can be used as confirmatory assessment) Subject anatomy with Ilio-femoral artery segment compatible with a 12 F device catheter size The subject and the treating physician agree that the subject will undergo the scheduled pre-procedural testing and return for all required post-procedure follow-up visits The subject, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee (EC) or Institutional Review Board (IRB) Exclusion Criteria: Clinical exclusion criteria (preoperative screening) Subjects with hypercoagulable state that cannot be corrected by additional periprocedural heparin Subjects with contraindication to cerebral MRI Subjects with a history of a stroke or transient ischemic attack within the prior 6 months Subjects with known diagnosis of acute myocardial infarction (AMI) within 30 days preceding the index procedure Renal insufficiency (creatinine > 3.0 mg/dL or Glomerular Filtration Rate GFR < 30) and/or renal replacement therapy at the time of screening Subjects with a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, patients who will refuse transfusion, or patients with an active peptic ulcer or history of upper gastrointestinal (GI) bleeding within the prior 3 months Subjects with known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, nitinol, stainless steel alloy, and/or contrast sensitivity that cannot be adequately pre-medicated Subject is currently participating in another drug or device clinical study or has other medical illnesses that may cause the subject to be non-compliant with the protocol or confound the data interpretation Subjects with a previously implanted prosthetic aortic valve (i.e., planned valve-in-valve with a TAVI) Subject requires an emergent procedure Subject has active major psychiatric disease Subjects with neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities Subject has an ejection fraction of 30% or less Subjects with active endocarditis or other systemic infection Subjects undergoing therapeutic thrombolysis Subject is pregnant or lactating. Pregnancy confirmed by positive urine or serum test Computerized Tomographic exclusion criteria (preoperative screening) Subjects with documented friable or mobile atherosclerotic plaque in the aortic arch Subjects with echocardiographic evidence of aortic mass, thrombus or vegetation Subjects with a diameter of the ascending aorta < 25 and > 39 mm at baseline CT (measured 10 mm upstream of the first vessel of the brachiocephalic trunk) Subjects undergoing transcatheter aortic valve implantation (TAVI) via the trans-axillary, trans-subclavian, or trans-aortic route Subjects with severe peripheral arterial, abdominal aortic, or thoracic aortic disease that precludes delivery of sheath vascular access Subjects in whom the aortic arch is heavily calcified, severely atheromatous, or severely tortuous

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAVI + Embolic protection<br>Subjects with severe native aortic valve stenosis who meet the clinically approved indications for aortic valve interventions such as TAVI | Procedure: TAVI (Transcatheter Aortic Valve Implant)<br>* Placement of a filter to capture and remove emboli or debris detached during any transcatheter heart procedures<br>Device: FLOWer Embolic Protection System<br>* FLOWer Embolic Protection System<br>* Other names: transcatheter embolic protection for TAVI procedures;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FLOWer System Safety, rate of Major Adverse Cardiac and Cerebrovascular Events | related to FLOWer Device or Procedure as adjudicated by a Clinical Event Committee MACCEs are based on the Valve Academic Research Consortium (VARC-3) criteria: all death, all stroke (disabling and non-disabling), and acute kidney injury (stage 3 at discharge or 72 hours post index procedure, whichever occurs first). | 7 and 30 days | 
| Cumulative occurrence of Serious Clinical Events related to device or procedure | death, stroke, bleeding, AKI, and procedural complications | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success | defined as successful placement, insertion and removal of the FLOWer System | immediately after procedure | 
| Debris capture | by the FLOWer System with gross and histopathological evaluation including particle size and composition | immediately after procedure | 
| FLOWer System Usability | graded by the Investigator with a 5-point Likert scale The minimum and the maximum values of the scale are defined as follows: (1) Unacceptable; (2) Poor; (3) Acceptable; (4) Good; (5) Excellent | immediately after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVI, Transcatheter Anti-embolic Filter, Cerebral Embolic Protection, Embolic Protection Device, Debris, Embolic material