The Sentinel Registry

Study Overview
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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.

Official Title
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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

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

Intervention / Treatment
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* Device: Sentinel


Participation Criteria
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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) 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. 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TAVR<br>Undergoing transcatheter aortic valve replacement patients | Device: Sentinel<br>* cerebral protection devices during transfemoral transcatheter aortic valve replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| The event rate of vascular complication |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral protection