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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
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The primary objective of this study is to prospectively investigate hemostatic activity following transcatheter left atrial appendage occlusion (LAAO).
This is a prospective cohort study of patients undergoing transcatheter LAAO at Aarhus University Hospital. Hemostatic consequences following device implantation will be evaluated using blood samples collected pre- and post-procedurally, and serially during three months follow-up in 135 LAAO patients. Platelet function and characteristics, overall activation of the extrinsic coagulation pathway and the intrinsic contact activation pathway, as well as endothelial response to implantation, will be assessed through a wide range of biochemical analyses. Patients will serve as their own controls, with a final control blood sample collected at three-months follow-up.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Left Atrial Appendage Occlusion | Device | Interventional left atrial appendage occlusion with the Amulet or Watchman device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in coagulation activity | Coagulation activity as measured by prothrombin fragment 1+2 | 7 days, 14 days, 90 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Only patients already eligible for LAAO will be screened by clinical personnel and potentially recruited for participation. Blood samples will be systematically sampled during planned follow-up timepoints.
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| Name | Affiliation | Role |
|---|---|---|
| Anders Kramer, MD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus N | Central Denmark | 8200 | Denmark |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000097546 | Left Atrial Appendage Closure |
| ID | Term |
|---|---|
| D006328 | Cardiac Catheterization |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |