Hemostatic Activity Following Left Atrial Appendage Occlusion
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- University of Aarhus
- Enrollment
- 135
- Locations
- 1
- Primary Endpoint
- Change in coagulation activity
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in coagulation activity
Time Frame: 7 days, 14 days, 90 days
Coagulation activity as measured by prothrombin fragment 1+2
Secondary Outcomes
- Non-procedural bleeding events(7 days, 14 days, 90 days)
- Additional measures of changes in coagulation and contact activation(7 days, 14 days, 90 days)
- Radiographical evidence of device endothelization(7 days, 14 days, 90 days)
- Change in platelet activity(7 days, 14 days, 90 days)
- Change in endothelial activation and response(7 days, 14 days, 90 days)
- Radiographically confirmed device-related thrombosis(7 days, 14 days, 90 days)