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Left Atrial Appendage Arrhythmogenic and Thrombogenic Substrate

ConditionsAtrial FibrillationStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Bispebjerg and Frederiksberg

About this trial

The purpose of the project is to elucidate whether it is possible to identify which patients are at risk of forming blood clots that can cause stroke based on analysis of the electrocardiogram.

In connection with the operation, the small pouch known as the auricle of the heart is closed, which can be completely removed after closing. This procedure is common in patients with atrial fibrillation to protect the brain from stroke. In the project, all patients will have this auricle closed if they agree to participate in the project.

After closure, the auricle is usually discarded. We will analyze the blood and the auricle tissue taken (if available) in connection with the operation itself, together with the analysis of the electrocardiogram recorded before the planned heart operation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

signed informed consent AND

CABG

valve repair or replacement

aorta surgery

Disqualifiers

current endocarditis

follow-up not possible

Trial design

Design model

Single group

Treatments tested in this trial

  • left atrial appendage closure

    Procedure/Surgery

    systematic closure of the left atrial appendage in addition to the planned heart surgery

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: LAA closureOther 1 intervention

Trial outcomes

Primary outcomes

1

stroke

number of patients with clinical stroke

Time frame
six years

Secondary outcomes

1

perioperative atrial fibrillation

number of patients with incident atrial fibrillation the days after surgery, prior to discharge

Time frame
30 days
2

silent brain infarctions

number of patients in whom asymptomatic ischemic infarctions are identified in brain scans (CTC or MRI)

Time frame
six years
3

occurrence of atrial fibrillation during follow-up

Time frame
ten years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Bispebjerg and Frederiksberg

Lead sponsor

Rigshospitalet, Denmark

Collaborator

University of Copenhagen

Collaborator

Source ClinicalTrials.gov
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