Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boston Scientific Corporation
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement
