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| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
| Boston Scientific Corporation | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAVR | Undergoing transcatheter aortic valve replacement patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sentinel | Device | cerebral protection devices during transfemoral transcatheter aortic valve replacement |
|
| 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
| 1 month |
| 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 |
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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)
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:
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Undergoing TAVR(transcatheter aortic valve replacement) with the use of SENTINEL embolic protection device
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bucheon Sejong Hospital | Bucheon-si | South Korea | ||||
| Keimyung University Dongsan Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40816554 | Derived | 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. |
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| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |
| 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 |