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    Summary
    The study has been updated to version v2.10.0, replacing the previous version v2.9.7.
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    Check dated 2024-07-23T14:48:25.000Z thumbnail image
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    The website has been updated to Revision v2.9.7 from v2.9.6.
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    The value of Revision has been updated from v2.9.5 to v2.9.6, indicating a recent revision in the content of the webpage.
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    The value of Revision has been updated from v2.9.3 to v2.9.5, indicating a recent revision in the content of the webpage.
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    The value of Revision has been updated from v2.9.1 to v2.9.3, indicating a recent revision in the content of the webpage.
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    32 days ago
    Change Detected
    Summary
    The value 'Show more Show more Revision: v2.9.0' has recently changed to 'Show less FDA Drug and Device Resources Show less Design Details Observational Model : Cohort Time Perspective: Prospective Groups and Interventions Intervention/Treatment Device : Left Atrial Appendage Occlusion Interventional left atrial appendage occlusion with the Amulet or Watchman device Other Names: Left Atrial Appendage Closure Primary Outcome Measures Outcome Measure Measure Description Time Frame Change in coagulation activity Coagulation activity as measured by prothrombin fragment 1+2 7 days, 14 days, 90 days Secondary Outcome Measures Outcome Measure Measure Description Time Frame Change in platelet activity Incl. platelet count, turnover, and aggregation 7 days, 14 days, 90 days Additional measures of changes in coagulation and contact activation Incl. thrombin generation, fibrinogen, d-dimer and coagulation factors 7 days, 14 days, 90 days Change in endothelial activation and response Incl. changes in soluble thrombomodulin, syndecan-1, selectin and von Willebrand factor 7 days, 14 days, 90 days Non-procedural bleeding events As defined by the Bleeding Academic Research Consortium 7 days, 14 days, 90 days Radiographical evidence of device endothelization On CT indicated by no contrast patency distal to the LAAO device. 7 days, 14 days, 90 days Radiographically confirmed device-related thrombosis Defined as high grade HAT on follow-up cardiac CT or TEE 7 days, 14 days, 90 days Additional Relevant MeSH Terms Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Atrial Fibrillation Studies a U.S. FDA-Regulated Drug Product No Studies a U.S. FDA-Regulated Device Product No Revision: v2.9.1'
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    Check dated 2024-06-25T08:29:36.000Z thumbnail image

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