Left Atrial Appendage Arrhythmogenic and Thrombogenic Substrate

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation; Stroke
• Interventions: Procedure: left atrial appendage closure

• Registration Number: NCT06405750
• Lead Sponsor: University Hospital Bispebjerg and Frederiksberg

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-05-05
• Study First Submitted QC: 2024-05-05
• Study First Posted: 2024-05-08
• Study Start: 2024-08-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09
• Primary Completion: 2035-12-31
• Study Completion: 2035-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LAA closure	left atrial appendage closure	All patients included in the study undergo closure of the Left Atrial Appendage

Primary Outcome Measures

Name	Time	Method
stroke	six years	number of patients with clinical stroke

Secondary Outcome Measures

Name	Time	Method
perioperative atrial fibrillation	30 days	number of patients with incident atrial fibrillation the days after surgery, prior to discharge
silent brain infarctions	six years	number of patients in whom asymptomatic ischemic infarctions are identified in brain scans (CTC or MRI)
occurrence of atrial fibrillation during follow-up	ten years

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark