Sentinel(TM) Post-Market Registry
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|ClinicalTrials.gov Identifier: NCT02255851|
Recruitment Status : Completed
First Posted : October 3, 2014
Last Update Posted : May 23, 2018
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.
|Condition or disease||Intervention/treatment|
|Transcatheter Aortic Valve Replacement Severe Symptomatic Calcified Native Aortic Valve Stenosis||Device: SENTINEL (Cerebral Protection System)|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||300 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Histopathology of Embolic Debris Captured During Transcatheter Aortic Valve Replacement|
|Actual Study Start Date :||March 2014|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
TAVR + SENTINEL (Cerebral Protection System)
Device: SENTINEL (Cerebral Protection System)
- Primary Observational Endpoint [ Time Frame: Post-Procedure (day 1) ]Capture rate, debris volume and histopathology analysis at day 1.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255851
|Principal Investigator:||Christoph Naber, MD||Elisabeth-Krankenhaus Essen GmbH, Essen, Germany|