The Sentinel Registry (Sentinel)

  • STATUS
    Recruiting
  • End date
    Mar 15, 2023
  • participants needed
    100
  • sponsor
    Duk-Woo Park, MD
Updated on 4 October 2022

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 compared with the extracted data from the TP TAVR registry(NCT038262664) using Propensity Score Matching.

Details
Condition Aortic Valve Disease, Transcatheter Aortic Valve Implantation, Transcatheter Aortic Valve Replacement
Treatment SENTINEL
Clinical Study IdentifierNCT05217888
SponsorDuk-Woo Park, MD
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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