Hemostatic Activity Following LAAO

Stroke Clinical Trial

Official title:

Hemostatic Activity Following Left Atrial Appendage Occlusion

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05011981
• Other study ID #: Hemo-LAAO
• Status: Active, not recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

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