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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05011981
Other study ID # Hemo-LAAO
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 11, 2021
Est. completion date December 2024

Study information

Verified date January 2024
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objective of this study is to prospectively investigate hemostatic activity following transcatheter left atrial appendage occlusion (LAAO).


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 135
Est. completion date December 2024
Est. primary completion date July 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Left Atrial Appendage Occlusion
Interventional left atrial appendage occlusion with the Amulet or Watchman device

Locations

Country Name City State
Denmark Aarhus University Hospital Aarhus N Central Denmark

Sponsors (2)

Lead Sponsor Collaborator
University of Aarhus Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in coagulation activity Coagulation activity as measured by prothrombin fragment 1+2 7 days, 14 days, 90 days
Secondary Change in platelet activity Incl. platelet count, turnover, and aggregation 7 days, 14 days, 90 days
Secondary Additional measures of changes in coagulation and contact activation Incl. thrombin generation, fibrinogen, d-dimer and coagulation factors 7 days, 14 days, 90 days
Secondary Change in endothelial activation and response Incl. changes in soluble thrombomodulin, syndecan-1, selectin and von Willebrand factor 7 days, 14 days, 90 days
Secondary Non-procedural bleeding events As defined by the Bleeding Academic Research Consortium 7 days, 14 days, 90 days
Secondary Radiographical evidence of device endothelization On CT indicated by no contrast patency distal to the LAAO device. 7 days, 14 days, 90 days
Secondary Radiographically confirmed device-related thrombosis Defined as high grade HAT on follow-up cardiac CT or TEE 7 days, 14 days, 90 days
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