Left Atrial Appendage Arrhythmogenic and Thrombogenic Substrate

NCT06405750 | Recruiting DMC

• 2 other identifiers: H-23015282P-2023-227
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Atrial Fibrillation

Keywords

heart surgery; atrial myocardiopathy; arrhythmogenic substrate; stroke; cerebral transitory ischemic attack; thrombogenesis; cardiac embolism

Outcome Measures

Primary Outcomes (1)

• stroke

  number of patients with clinical stroke

  six years

Secondary Outcomes (3)

• perioperative atrial fibrillation

  30 days

• silent brain infarctions

  six years

• occurrence of atrial fibrillation during follow-up

  ten years

Study Arms (1)

LAA closure

OTHER

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

Procedure: left atrial appendage closure

Interventions

left atrial appendage closure PROCEDURE

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

LAA closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• current endocarditis
• follow-up not possible

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead
• Rigshospitalet, Denmark: collaborator
• University of Copenhagen: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Interventions

Left Atrial Appendage Closure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cardiac Catheterization; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• Helena Dominguez

  University Hospital Bispebjerg and Frederiksberg

  STUDY DIRECTOR

Central Study Contacts

Helena DOMINGUEZ, MD, PhD

CONTACT

4522989343; mdom0002@regionh.dk

Ida Gustafsson, MD, PhD

CONTACT

4538635000; ida.gustafsson@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Associate Professor

Model Details: Mechanistic study based on analysis of biological material collected along with electrocardiogram features on individuals undergoing open-heart surgery

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 8, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

DK (1)