Brief Title
Clinical Study of a Novel Transcatheter Anti-embolic Filter for Cerebral Protection During Aortic Valve Interventions
Official Title
Clinical Study of a Novel Transcatheter Anti-embolic Filter (TAF) for Cerebral Protection During Aortic Valve Interventions
Brief Summary
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).
Detailed Description
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.
Study Type
Interventional
Primary Outcome
TAF System Safety, rate of Major Adverse Cardiac and Cerebrovascular Events (MACCEs)
Secondary Outcome
Technical Success
Condition
Aortic Valve Stenosis
Intervention
TAVI (Transcatheter Aortic Valve Implant)
Study Arms / Comparison Groups
TAVI + Embolic protection
Description: Subjects with severe native aortic valve stenosis who meet the clinically approved indications for aortic valve interventions such as TAVI
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
40
Start Date
January 2021
Completion Date
November 2021
Primary Completion Date
October 2021
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Franco Osta, +41795388214, [email protected]
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT04704258
Organization ID
#2020-01 (EU)
Responsible Party
Sponsor
Study Sponsor
AorticLab Srl
Study Sponsor
Franco Osta, Study Chair, AorticLab Srl
Verification Date
January 2021