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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05217888

Acronym

Sentinel

Enrollment

158

Registered

2022-02-01

Start date

2022-05-18

Completion date

2025-05-20

Last updated

2025-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Disease, Transcatheter Aortic Valve Implantation, Transcatheter Aortic Valve Replacement

Keywords

Cerebral protection

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.

Interventions

DEVICESentinel

cerebral protection devices during transfemoral transcatheter aortic valve replacement

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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 * 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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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
The event rate of death from any cause	1 month
The event rate of bleeding	1 month
The event rate of acute kidney injury	1 month
The event rate of repeat hospitalization	1 month
The event rate of vascular complication	1 month

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026