Hemostatic Activity Following LAAO

NCT ID: NCT05011981

Last Updated: 2024-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-11

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Atrial Fibrillation Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Left Atrial Appendage Occlusion

Interventional left atrial appendage occlusion with the Amulet or Watchman device

Intervention Type DEVICE

Other Intervention Names

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Left Atrial Appendage Closure

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anders Kramer, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Aarhus University Hospital

Aarhus N, Central Denmark, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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Hemo-LAAO

Identifier Type: -

Identifier Source: org_study_id

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