Hemostatic Activity Following LAAO

Active, not recruiting

• Conditions: Stroke; Atrial Fibrillation

• Registration Number: NCT05011981
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Study First Submitted: 2021-08-12
• Study First Submitted QC: 2021-08-17
• Study First Posted: 2021-08-18
• Study Start: 2021-10-11
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-11
• Primary Completion: 2024-07
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in coagulation activity	7 days, 14 days, 90 days	Coagulation activity as measured by prothrombin fragment 1+2

Secondary Outcome Measures

Name	Time	Method
Non-procedural bleeding events	7 days, 14 days, 90 days	As defined by the Bleeding Academic Research Consortium
Additional measures of changes in coagulation and contact activation	7 days, 14 days, 90 days	Incl. thrombin generation, fibrinogen, d-dimer and coagulation factors
Radiographical evidence of device endothelization	7 days, 14 days, 90 days	On CT indicated by no contrast patency distal to the LAAO device.
Change in platelet activity	7 days, 14 days, 90 days	Incl. platelet count, turnover, and aggregation
Change in endothelial activation and response	7 days, 14 days, 90 days	Incl. changes in soluble thrombomodulin, syndecan-1, selectin and von Willebrand factor
Radiographically confirmed device-related thrombosis	7 days, 14 days, 90 days	Defined as high grade HAT on follow-up cardiac CT or TEE

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus N, Central Denmark, Denmark