Clinical Study of a Novel Transcatheter Anti-embolic Filter for Cerebral Protection During Aortic Valve Interventions
Clinical Study of a Novel Transcatheter Anti-embolic Filter for Cerebral Protection During Aortic Valve Interventions
The purpose of this clinical study is to assess the safety, performance and treatment effect
 of the use of AorticLab Transcatheter Antiembolic Filter (TAF), in preventing cerebral
 thromboembolic complications in patients with indication for a TAVI (Transcatheter Aortic
 Valve Implant).
A single arm, prospective, multicenter non-randomized clinical study of the AorticLab TAF
 System to prevent embolic complications during transcatheter aortic valve procedures. Forty
 participants will be enrolled at up to six sites in Europe and will undergo clinical
 follow-up at 24hrs ± 8hrs post-procedure, discharge or 7 days, whichever comes first and 30
 days.
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 < 29 and > 34 mm at baseline CT
 (measured between 1 and 10 mm upstream 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 sheath vascular access

 6. Subjects in whom the aortic arch is heavily calcified, severely atheromatous, or
 severely tortuous