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

AorticLab

Status: Completed

Conditions: Aortic Valve Stenosis; Intracranial Embolism and Thrombosis

Treatments: Device: FLOWer Embolic Protection System; Procedure: TAVI (Transcatheter Aortic Valve Implant)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04704258

#2020-01 (EU)

Details and patient eligibility

About

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).

Full description

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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects of age ≥ 18 years
2. 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)
3. Subject anatomy with Ilio-femoral artery segment compatible with a 12 F device catheter size
4. 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
5. 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)

1. Subjects with hypercoagulable state that cannot be corrected by additional periprocedural heparin
2. Subjects with contraindication to cerebral MRI
3. Subjects with a history of a stroke or transient ischemic attack within the prior 6 months
4. Subjects with known diagnosis of acute myocardial infarction (AMI) within 30 days preceding the index procedure
5. Renal insufficiency (creatinine > 3.0 mg/dL or Glomerular Filtration Rate GFR < 30) and/or renal replacement therapy at the time of screening
6. 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
7. 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
8. 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
9. Subjects with a previously implanted prosthetic aortic valve (i.e., planned valve-in-valve with a TAVI)
10. Subject requires an emergent procedure
11. Subject has active major psychiatric disease
12. Subjects with neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities
13. Subject has an ejection fraction of 30% or less
14. Subjects with active endocarditis or other systemic infection
15. Subjects undergoing therapeutic thrombolysis
16. Subject is pregnant or lactating. Pregnancy confirmed by positive urine or serum test

Computerized Tomographic exclusion criteria (preoperative screening)

1. Subjects with documented friable or mobile atherosclerotic plaque in the aortic arch
2. Subjects with echocardiographic evidence of aortic mass, thrombus or vegetation
3. 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)
4. Subjects undergoing transcatheter aortic valve implantation (TAVI) via the trans-axillary, trans-subclavian, or trans-aortic route
5. Subjects with severe peripheral arterial, abdominal aortic, or thoracic aortic disease that precludes delivery of sheath vascular access
6. Subjects in whom the aortic arch is heavily calcified, severely atheromatous, or severely tortuous

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

TAVI + Embolic protection

Experimental group

Description:

Subjects with severe native aortic valve stenosis who meet the clinically approved indications for aortic valve interventions such as TAVI

Treatment:

Procedure: TAVI (Transcatheter Aortic Valve Implant)

Device: FLOWer Embolic Protection System