Evaluation of Procedural outcomes and Safety of Cerebral Embolic Protection Device for Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement in Routine Clinical Practice

Asan Medical Center0 个研究点目标入组 100 人开始时间: 待定最近更新: 2022年3月8日

试验速览

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•1. Patients was > 19 years of age
•2. Patients with symptomatic severe aortic stenosis who planned TAVR with the use of SENTINEL embolic protection device
•3. Higher risk of cerebrovascular embolic events (any of the followings)
•1) Bicuspid aortic valve
•2) Calcified lesion or atherosclerosis in the ascending aorta and/or aortic arch
•3) Heavy calcified aortic valve (Ca. volume > 1000)
•4) Chronic kidney disease
•5) Prior stroke
•6) Stroke risk is strongly anticipated by attending physicians
•4. Compatible carotid and brachiocephalic artery anatomy for SENTINEL device as determined by Multi-Slice Computed Tomography scan or equivalent imaging modality
•5. The patient or guardian 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.

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

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