Hemostatic Activity Following LAAO

January 10, 2024 updated by: University of Aarhus

Hemostatic Activity Following Left Atrial Appendage Occlusion

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Central Denmark
      • Aarhus N, Central Denmark, Denmark, 8200
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Only patients already eligible for LAAO will be screened by clinical personnel and potentially recruited for participation. Blood samples will be systematically sampled during planned follow-up timepoints.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in coagulation activity
Time Frame: 7 days, 14 days, 90 days
Coagulation activity as measured by prothrombin fragment 1+2
7 days, 14 days, 90 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital

Investigators

  • Principal Investigator: Anders Kramer, MD, Aarhus University Hospital, Aarhus, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2021

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 12, 2021

First Submitted That Met QC Criteria

August 17, 2021

First Posted (Actual)

August 18, 2021

Study Record Updates

Last Update Posted (Actual)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hemo-LAAO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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