Left Atrial Appendage Arrhythmogenic and Thrombogenic Substrate (LAATAS)

University Hospital Bispebjerg and Frederiksberg

Status: Enrolling

Conditions: Atrial Fibrillation; Stroke

Treatments: Procedure: left atrial appendage closure

Study type: Interventional

Funder types: Other

Identifiers

NCT06405750

P-2023-227 (Other Identifier)

H-23015282

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1,000 participants in 1 patient group

LAA closure

Other group

Description:

All patients included in the study undergo closure of the Left Atrial Appendage

Treatment:

Procedure: left atrial appendage closure