NAUTILUS CE-mark Trial of the FLOWer Cerebral Embolic Protection Device (NCT04704258) | Clinical Trial Compass
CompletedNot Applicable
NAUTILUS CE-mark Trial of the FLOWer Cerebral Embolic Protection Device
Belgium, Italy100 participantsStarted 2021-05-03
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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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
✕. 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
What they're measuring
1
FLOWer Device Safety: Rate of Major Adverse Cardiac and Cerebrovascular Events
Timeframe: 30 days
2
Reduction in total volume of new cerebral lesions in all territories at serial DWMRI
Timeframe: Within 2-5 days after procedure vs. baseline
. 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