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NCT Number: NCT06405750

Left Atrial Appendage Arrhythmogenic and Thrombogenic Substrate

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, Denmark

Location status: Recruiting

Location contact

Christian L Carranza

CONTACT

About this study

Patients scheduled for elective heart surgery are invited to participate. After informed consent is signed, an ECG and blood samples are gathered the day before surgery or the same day of the surgery is planned.

During surgery, the patients undergo closure of the left atrial appendage (LAA). The choice of the device is at the discretion of the surgeon. If possible, the entire LAA is removed and processed for further analysis. The right atrial appendage is likewise removed and follows the same procedure as the LAA.

The analyses include measurement of up-/down-regulated thrombosis factors and inflammatory markers.

The right and left atrial appendage tissue collected are immediately processed for micro-patch-clamp studies, and the remaining tissue is divided into a part that is frozen for later analyses and a part that is fixed and embedded in paraffin for further histological analyses.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • signed informed consent AND
  • planned any open-heart surgery:
  • CABG
  • valve repair or replacement
  • aorta surgery
  • any combination of the above

Exclusion criteria

  • current endocarditis
  • follow-up not possible

Treatment and study plan

Left atrial appendage closure

Procedure

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

Primary outcomes

  1. stroke

    Time frame: six years

    number of patients with clinical stroke

Secondary outcomes

  1. perioperative atrial fibrillation

    Time frame: 30 days

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

  2. silent brain infarctions

    Time frame: six years

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

  3. occurrence of atrial fibrillation during follow-up

    Time frame: ten years

Study contacts

Contact information is provided by the study sponsor or research team.

Helena DOMINGUEZ, MD, PhD

CONTACT

[email protected]

4522989343

Ida Gustafsson, MD, PhD

CONTACT

[email protected]

4538635000

Sponsors and collaborators

Lead sponsor

University Hospital Bispebjerg and Frederiksberg

Other

Collaborators

  • Rigshospitalet, Denmark
  • University of Copenhagen

Registry information

Acronym: LAATAS

Important dates

Study start
2024
Primary completion
2035
Study completion
2035
First posted
May 8, 2024
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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