PROTECTED TAVR: Stroke PROTECTion with SEntinel During Transcatheter Aortic Valve Replacement

Withdrawn

Conditions: eurological
Stroke protection
Stroke protection during Transcatheter Aortic Valve Replacement
10046973
10003184

Registration Number: NL-OMON49631

Lead Sponsor: Boston Scientific Cooperation International

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

All eligible subjects should be approached for participation in the trial.
Subjects who meet all of the following criteria will be evaluated for
enrollment in this trial, provided no exclusion criterion
(below) is met.
IC1. Subject has documented aortic valve stenosis and is treated with an
approved TAVR device via transfemoral access.
IC2. Subject has the recommended artery diameter at the site of filter
placement per the Sentinel® Cerebral Protection System Instructions For Use: 9*
15 mm for the brachiocephalic artery and
6.5*10 mm in the left common carotid artery.
IC3. Subject (or legal representative) provides written informed consent.

Exclusion Criteria

Subjects who meet any one of the following criteria (listed as
contraindications in the Sentinel® Cerebral Protection System IFU) will be
excluded from this clinical trial.
EC1. Subject has arterial stenosis >70% in either the left common carotid
artery or the brachiocephalic artery.
EC2. Subject*s brachiocephalic or left carotid artery reveals significant
stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm
of the aortic ostium.
EC3. Subject has compromised blood flow to the right upper extremity.
EC4. Subject has access vessels with excessive tortuosity.
EC5. Subject has uncorrected bleeding disorders.
EC6. Subject is contraindicated for anticoagulant and antiplatelet
therapy.
Note 4: Use of general anesthesia during TAVR may affect neurocognitive
function shortly after the procedure. While not an exclusion criterion, it is
recommended that general anesthesia not be
used if possible.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is all stroke (hemorrhagic, ischemic, or undetermined<br /><br>status; disabling or nondisabling) through 72 hours<br /><br>post TAVR procedure or discharge (whichever comes first), as adjudicated by an<br /><br>independent Clinical Events Committee (CEC)<br /><br>and using Neurologic Academic Research Consortium (NeuroARCa) definitions.</p><br>

Secondary Outcome Measures