The Sentinel Registry

NCT05217888 | Completed

• 1 other identifier: AMCCV 2022-01
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 10

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.

Conditions

Aortic Valve Disease; Transcatheter Aortic Valve Implantation; Transcatheter Aortic Valve Replacement

Keywords

Cerebral protection

Outcome Measures

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)

  1 month

Secondary Outcomes (9)

• The event rate of death from any cause

  1 month

• The event rate of cardiac death

  1 month

• The event rate of stroke

  1 month

• The event rate of myocardial infarction

  1 month

• The event rate of systemic embolic event

  1 month

Study Arms (1)

TAVR

Undergoing transcatheter aortic valve replacement patients

Device: Sentinel

Interventions

Sentinel DEVICE

cerebral protection devices during transfemoral transcatheter aortic valve replacement

TAVR

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (10)

Bucheon Sejong Hospital

Bucheon-si, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Seoul university Bundang hospital

Seongnam-si, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Samsung medical center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, South Korea

Location

Related Publications (1)

• Park HS, Suh CH, Ahn JM, Kang DY, Ahn SY, Wee SB, Lee SH, Seo KW, Kim MJ, Park SJ, Park DW. Effect of cerebral embolic protection device on new cerebral embolism during transcatheter aortic valve replacement: A prospective sentinel registry. Am Heart J. 2026 Jan;291:44-52. doi: 10.1016/j.ahj.2025.08.006. Epub 2025 Aug 14.

  PMID: 40816554 DERIVED

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: February 1, 2022
• Study Start: May 18, 2022
• Primary Completion: May 20, 2025
• Study Completion: May 20, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

KR (10)