The Sentinel Registry

Last updated: December 19, 2024
Sponsor: Duk-Woo Park, MD
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Valve Disease

Treatment

Sentinel

Clinical Study ID

NCT05217888
AMCCV 2022-01
  • Ages > 19
  • All Genders

Study 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.

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)

  1. Bicuspid aortic valve

  2. Calcified lesion or atherosclerosis in the ascending aorta and/or aortic arch

  3. Heavy calcified aortic valve (Ca. volume > 500)

  4. Chronic kidney disease

  5. Prior stroke

  6. 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

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Sentinel
Phase:
Study Start date:
May 18, 2022
Estimated Completion Date:
April 30, 2025

Connect with a study center

  • Bucheon Sejong Hospital

    Bucheon,
    Korea, Republic of

    Completed

  • Keimyung University Dongsan Medical Center

    Daegu,
    Korea, Republic of

    Completed

  • Chonnam National University Hospital

    Gwangju,
    Korea, Republic of

    Completed

  • Bundang CHA Hospital

    Seongnam,
    Korea, Republic of

    Site Not Available

  • Seoul university Bundang hospital

    Seongnam-si,
    Korea, Republic of

    Completed

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Korea University Anam Hospital

    Seoul,
    Korea, Republic of

    Completed

  • Samsung medical center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Completed

  • Severance Hospital

    Seoul,
    Korea, Republic of

    Completed

  • Pusan National University Yangsan Hospital

    Yangsan,
    Korea, Republic of

    Terminated

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