The Sentinel Registry

Inclusion criteria

• Age 19 and more
• Undergoing TAVR with the use of SENTINEL embolic protection device
• Higher risk of cerebrovascular embolic events (any of the followings)

• Bicuspid aortic valve
• Calcified lesion or atherosclerosis in the ascending aorta and/or aortic arch
• Heavy calcified aortic valve (Ca. volume > 500)
• Chronic kidney disease
• Prior stroke
• Stroke risk is strongly anticipated by attending physicians
• Compatible carotid and brachiocephalic artery anatomy for SENTINEL device as determined by Multi-Slice Computed Tomography scan or equivalent imaging modality
• Agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion criteria

• Vasculature in the right extremity precluding radial or brachial access
• Excessive tortuosity in the right radial/brachial/subclavian artery preventing Sentinel System access and insertion
• Inadequate circulation to the right extremity as evidenced by signs of artery occlusion (modified Allen's test) or absence of radial/brachial pulse
• Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature
• Symptomatic or asymptomatic severe occlusive carotid disease requiring concomitant carotid endarterectomy/stenting
• Undergone carotid stenting or carotid endarterectomy within the previous 6 weeks
• Concurrent medical condition with a life expectancy of less than 1 year