Left Atrial Appendage Arrhythmogenic and Thrombogenic Substrate (LAATAS)

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Atrial Fibrillation
• Intervention / Treatment: Procedure: left atrial appendage closure

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 Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Helena DOMINGUEZ, MD, PhD; Phone Number: 4522989343; Email: mdom0002@regionh.dk
• Study Contact Backup: Name: Ida Gustafsson, MD, PhD; Phone Number: 4538635000; Email: ida.gustafsson@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Recruiting
    • Rigshospitalet
    • Contact: Christian L Carranza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: LAA closure; All patients included in the study undergo closure of the Left Atrial Appendage	Procedure: left atrial appendage closure; systematic closure of the left atrial appendage in addition to the planned heart surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stroke	number of patients with clinical stroke	six years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital Bispebjerg and Frederiksberg
• Collaborators: Rigshospitalet, Denmark; University of Copenhagen
• Investigators: Study Director: Helena Dominguez, University Hospital Bispebjerg and Frederiksberg

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035

Study Registration Dates

• First Submitted: May 5, 2024
• First Submitted That Met QC Criteria: May 5, 2024
• First Posted (Actual): May 8, 2024

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: stroke; heart surgery; cardiac embolism; atrial myocardiopathy; arrhythmogenic substrate; cerebral transitory ischemic attack; thrombogenesis
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Stroke; Atrial Fibrillation; Investigative Techniques; Therapeutics; Catheterization; Cardiac Catheterization; Left Atrial Appendage Closure
• Other Study ID Numbers: H-23015282; P-2023-227 (Other Identifier: Capital Region Denmark)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No