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CompletedNCT05217888SentinelUpdated Jun 13, 2025

The Sentinel Registry

An observational study in Aortic Valve Disease, Transcatheter Aortic Valve Implantation and Transcatheter Aortic Valve Replacement, sponsored by Duk-Woo Park, MD. Completed at 10 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-06-13.

Sponsored by Duk-Woo Park, MD · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
158
Ages
19 Years and older
Sex
All
01

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.

02

Conditions studied

  • Aortic Valve Disease
  • Transcatheter Aortic Valve Implantation
  • Transcatheter Aortic Valve Replacement

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Keywords

  • Cerebral protection
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Undergoing TAVR(transcatheter aortic valve replacement) with the use of SENTINEL embolic protection device

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 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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
158 participants (actual)
Target follow-up
1 Month
Patient registry
Yes

Groups and cohorts

  • TAVR

    Undergoing transcatheter aortic valve replacement patients

    Device: Sentinel

Interventions

  • DeviceSentinel

    cerebral protection devices during transfemoral transcatheter aortic valve replacement

05

What researchers measure

Primary outcomes

  1. The rate of procedural success

    Procedural Success: Sentinel system acute delivery and retrieval (categorized as successful deployment of both filters, 1 filter, or no filter and retrieval of the system) Procedural outcomes * Procedure time(min) * Positioning time * Total fluoroscopy time * Total contrast used * Total procedure index time * Sentinel access site vascular complications related to the procedure (major and minor)

    Time frame: 1 month

Secondary outcomes

  1. The event rate of death from any cause

    Time frame: 1 month

  2. The event rate of cardiac death

    Time frame: 1 month

  3. The event rate of stroke

    Time frame: 1 month

  4. The event rate of myocardial infarction

    Time frame: 1 month

  5. The event rate of systemic embolic event

    Time frame: 1 month

  6. The event rate of vascular complication

    Time frame: 1 month

  7. The event rate of bleeding

    Time frame: 1 month

  8. The event rate of acute kidney injury

    Time frame: 1 month

  9. The event rate of repeat hospitalization

    Time frame: 1 month

06

Study locations

10 sites
  • Bucheon Sejong Hospital
    Bucheon, Korea, Republic of
  • Keimyung University Dongsan Medical Center
    Daegu, Korea, Republic of
  • Chonnam National University Hospital
    Gwangju, Korea, Republic of
  • Seoul university Bundang hospital
    Seongnam-si, Korea, Republic of
  • Asan Medical Center
    Seoul, Korea, Republic of
  • Korea University Anam Hospital
    Seoul, Korea, Republic of
  • Samsung medical center
    Seoul, Korea, Republic of
  • Seoul National University Hospital
    Seoul, Korea, Republic of
  • Severance Hospital
    Seoul, Korea, Republic of
  • Pusan National University Yangsan Hospital
    Yangsan, Korea, Republic of
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05217888
Lead sponsor
Duk-Woo Park, MD
Collaborators
CardioVascular Research Foundation, Korea, Boston Scientific Corporation
Responsible party
Duk-Woo Park, MD (Professor, Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea, Asan Medical Center) — Sponsor-investigator
First posted
Feb 1, 2022
Start date
May 18, 2022
Primary completion
May 20, 2025
Completion
May 20, 2025
Last update
Jun 13, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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