Phase
Condition
Heart Valve Disease
Treatment
Sentinel
Clinical Study ID
Ages > 19 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 asdetermined by Multi-Slice Computed Tomography scan or equivalent imaging modality
Agrees to the study protocol and the schedule of clinical follow-up and providesinformed, written consent, as approved by the appropriate Institutional ReviewBoard/Ethical Committee of the respective clinical site.
Exclusion
Exclusion Criteria:
Vasculature in the right extremity precluding radial or brachial access
Excessive tortuosity in the right radial/brachial/subclavian artery preventingSentinel System access and insertion
Inadequate circulation to the right extremity as evidenced by signs of arteryocclusion (modified Allen's test) or absence of radial/brachial pulse
Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremityvasculature
Symptomatic or asymptomatic severe occlusive carotid disease requiring concomitantcarotid 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
Study Design
Connect with a study center
Bucheon Sejong Hospital
Bucheon,
Korea, Republic ofCompleted
Keimyung University Dongsan Medical Center
Daegu,
Korea, Republic ofCompleted
Chonnam National University Hospital
Gwangju,
Korea, Republic ofCompleted
Bundang CHA Hospital
Seongnam,
Korea, Republic ofSite Not Available
Seoul university Bundang hospital
Seongnam-si,
Korea, Republic ofCompleted
Asan Medical Center
Seoul,
Korea, Republic ofActive - Recruiting
Korea University Anam Hospital
Seoul,
Korea, Republic ofCompleted
Samsung medical center
Seoul,
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul,
Korea, Republic ofCompleted
Severance Hospital
Seoul,
Korea, Republic ofCompleted
Pusan National University Yangsan Hospital
Yangsan,
Korea, Republic ofTerminated
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