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The Sentinel Registry

Sponsor
Duk-Woo Park, MD (Other)
Overall Status
Recruiting
CT.gov ID
NCT05217888
Collaborator
CardioVascular Research Foundation, Korea (Other), Boston Scientific Corporation (Industry)
100
Enrollment
10
Locations
9.9
Anticipated Duration (Months)
10
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: Sentinel

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of Procedural Outcomes and Safety of Cerebral Embolic Protection Device for Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement in Routine Clinical Practice, A Multicenter, Prospective Observational Study
Actual Study Start Date :
May 18, 2022
Anticipated Primary Completion Date :
Feb 15, 2023
Anticipated Study Completion Date :
Mar 15, 2023

Arms and Interventions

Arm Intervention/Treatment
TAVR

Undergoing transcatheter aortic valve replacement patients

Device: Sentinel
cerebral protection devices during transfemoral transcatheter aortic valve replacement

Outcome Measures

Primary Outcome Measures

  1. The rate of procedural success [1 month]

    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)

Secondary Outcome Measures

  1. The event rate of death from any cause [1 month]

  2. The event rate of cardiac death [1 month]

  3. The event rate of stroke [1 month]

  4. The event rate of myocardial infarction [1 month]

  5. The event rate of systemic embolic event [1 month]

  6. The event rate of vascular complication [1 month]

  7. The event rate of bleeding [1 month]

  8. The event rate of acute kidney injury [1 month]

  9. The event rate of repeat hospitalization [1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bucheon Sejong Hospital Bucheon Korea, Republic of
2 Keimyung University Dongsan Medical Center Daegu Korea, Republic of
3 Chonnam National University Hospital Gwangju Korea, Republic of
4 Bundang CHA Hospital Seongnam Korea, Republic of
5 Asan Medical Center Seoul Korea, Republic of
6 Korea University Anam Hospital Seoul Korea, Republic of
7 Samsung medical center Seoul Korea, Republic of
8 Seoul National University Hospital Seoul Korea, Republic of
9 Severance Hospital Seoul Korea, Republic of
10 Pusan National University Yangsan Hospital Yangsan Korea, Republic of

Sponsors and Collaborators

  • Duk-Woo Park, MD
  • CardioVascular Research Foundation, Korea
  • Boston Scientific Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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
ClinicalTrials.gov Identifier:
NCT05217888
Other Study ID Numbers:
  • AMCCV 2021-12
First Posted:
Feb 1, 2022
Last Update Posted:
Jul 1, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Duk-Woo Park, MD, Professor, Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea, Asan Medical Center
Cerebral protection
Additional relevant MeSH terms:
Aortic Valve Disease

Study Results

No Results Posted as of Jul 1, 2022