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The SENTINEL Post-Market Registry is a prospective, multi-center, registry using the CE-Marked Sentinel System in subjects with severe symptomatic calcified native aortic valve stenosis indicated for TAVR.
Subjects enrolled in the registry will undergo TAVR + Sentinel. Basic demographic information and detailed procedural data will be captured and documented in a registry case report form.
All Sentinel filters will be sent for histopathology at an independent core-lab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | TAVR + SENTINEL (Cerebral Protection System) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SENTINEL (Cerebral Protection System) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Observational Endpoint | Capture rate, debris volume and histopathology analysis at day 1. | Post-Procedure (day 1) |
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Inclusion Criteria:
Exclusion Criteria:
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The registry population comprises subjects with severe symptomatic calcified native aortic valve stenosis who are selected for TAVR by heart team consensus and treated with CE-Marked TAVR devices.
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Naber, MD | Elisabeth-Krankenhaus Essen GmbH, Essen, Germany | Principal Investigator |
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Capture and histopathology analysis of embolic debris. (Thrombus, valve tissue, amorphous calcium, etc.)