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The Sentinel Registry | Clinical Trials | Clareo Health

COMPLETED

The Sentinel Registry

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

NCT05217888•Duk-Woo Park, MD

View on ClinicalTrials.gov

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

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more 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

Locations (10)

Bucheon Sejong Hospital

Bucheon-si, South Korea

Keimyung University Dongsan Medical Center

Daegu, South Korea

Chonnam National University Hospital

Gwangju, South Korea

Seoul university Bundang hospital

Seongnam-si, South Korea

Asan Medical Center

Seoul, South Korea

Korea University Anam Hospital

Seoul, South Korea

Samsung medical center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Pusan National University Yangsan Hospital

Yangsan, South Korea

Key Dates

Start Date

May 18, 2022

Primary Completion Date

May 20, 2025

Completion Date

May 20, 2025

Last Updated

June 13, 2025

Enrollment

158

ACTUAL participants

Conditions

Aortic Valve DiseaseTranscatheter Aortic Valve ImplantationTranscatheter Aortic Valve Replacement

Interventions

Sentinel

DEVICE

SAvvywire for Pacing and Procedural Hemodynamics In Transcatheter Aortic Valve Replacement Evaluation

NCT07366671

TAVI(Transcatheter Aortic Valve Implantation)Aortic Valve Disease

View study

RECRUITINGNA

J-Valve Transfemoral Pivotal Study

NCT06455787

Aortic Valve RegurgitationAortic Valve Disease Mixed

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

The Sentinel Registry

Inclusion Criteria

Exclusion Criteria

SAvvywire for Pacing and Procedural Hemodynamics In Transcatheter Aortic Valve Replacement Evaluation

J-Valve Transfemoral Pivotal Study

Prospective Long-Term Outcomes of a Standardized Ross Procedure

Valved Graft PMCF Study

The EASE-IT CT Registry

Short Versus Long Antiplatelet Therapy After TAVI