Atrial Fibrillation, Stroke
Conditions
Brief summary
The primary objective of this study is to prospectively investigate hemostatic activity following transcatheter left atrial appendage occlusion (LAAO).
Detailed description
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.
Interventions
DEVICELeft Atrial Appendage Occlusion
Interventional left atrial appendage occlusion with the Amulet or Watchman device
Sponsors
Aarhus University Hospital
University of Aarhus
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Age \> 18 years * Atrial fibrillation (paroxysmal, persistent, or permanent) * Admitted and eligible for LAAO * Signed written consent
Exclusion criteria
* Known hereditary bleeding disorders (i.e. Hemophilia A and B, Von Willebrand disease) * Platelet count \< 75 x 109/ml
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in coagulation activity | 7 days, 14 days, 90 days | Coagulation activity as measured by prothrombin fragment 1+2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional measures of changes in coagulation and contact activation | 7 days, 14 days, 90 days | Incl. thrombin generation, fibrinogen, d-dimer and coagulation factors |
| Change in endothelial activation and response | 7 days, 14 days, 90 days | Incl. changes in soluble thrombomodulin, syndecan-1, selectin and von Willebrand factor |
| Change in platelet activity | 7 days, 14 days, 90 days | Incl. platelet count, turnover, and aggregation |
| Radiographical evidence of device endothelization | 7 days, 14 days, 90 days | On CT indicated by no contrast patency distal to the LAAO device. |
| Radiographically confirmed device-related thrombosis | 7 days, 14 days, 90 days | Defined as high grade HAT on follow-up cardiac CT or TEE |
| Non-procedural bleeding events | 7 days, 14 days, 90 days | As defined by the Bleeding Academic Research Consortium |
Countries
Denmark
Outcome results
None listed