PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement
PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement
To demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the
 risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement
 (TAVR).
Inclusion Criteria:

 -  Subject has documented aortic valve stenosis and is treated with an approved TAVR
 device via transfemoral access

 -  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.

 -  Subject (or legal representative) provides written informed consent.

 Exclusion Criteria:

 -  Subject has arterial stenosis >70% in either the left common carotid artery or the
 brachiocephalic artery.

 -  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.

 -  Subject has compromised blood flow to the right upper extremity.

 -  Subject has access vessels with excessive tortuosity.

 -  Subject has uncorrected bleeding disorders.

 -  Subject is contraindicated for anticoagulant and antiplatelet therapy.