Status:
COMPLETED
The Sentinel Registry
Lead Sponsor:
Duk-Woo Park, MD
Collaborating Sponsors:
CardioVascular Research Foundation, Korea
Boston Scientific Corporation
Conditions:
Aortic Valve Disease
Transcatheter Aortic Valve Implantation
Eligibility:
All Genders
19+ years
Brief Summary
This registry is to evaluate procedural outcomes and safety outcomes of cerebral protection devices during transfemoral TAVR in real-world clinical practice. The data from this registry will be compa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 18 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 20 2025
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT05217888
Start Date
May 18 2022
End Date
May 20 2025
Last Update
June 13 2025
Active Locations (10)
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1
Bucheon Sejong Hospital
Bucheon-si, South Korea
2
Keimyung University Dongsan Medical Center
Daegu, South Korea
3
Chonnam National University Hospital
Gwangju, South Korea
4
Seoul university Bundang hospital
Seongnam-si, South Korea