Clinical Study of a Novel Transcatheter Anti-embolic Filter for Cerebral Protection During Aortic Valve Interventions

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

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