The Sentinel Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

158 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-18

Study Completion Date

2025-05-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Aortic Valve Disease Transcatheter Aortic Valve Implantation Transcatheter Aortic Valve Replacement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TAVR

Undergoing transcatheter aortic valve replacement patients

Sentinel

Intervention Type DEVICE

cerebral protection devices during transfemoral transcatheter aortic valve replacement

Interventions

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Sentinel

cerebral protection devices during transfemoral transcatheter aortic valve replacement

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No