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Left Atrial Appendage Arrhythmogenic and Thrombogenic Substrate

Left Atrial Appendage Arrhythmogenic and Thrombogenic Substrate

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06405750
Acronym
LAATAS
Enrollment
1000
Registered
2024-05-08
Start date
2024-08-01
Completion date
2035-12-31
Last updated
2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Stroke

Keywords

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

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.

Interventions

PROCEDUREleft atrial appendage closure

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

Sponsors

University Hospital Bispebjerg and Frederiksberg
Lead SponsorOTHER
Rigshospitalet, Denmark
CollaboratorOTHER
University of Copenhagen
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
strokesix yearsnumber of patients with clinical stroke

Secondary

MeasureTime frameDescription
perioperative atrial fibrillation30 daysnumber of patients with incident atrial fibrillation the days after surgery, prior to discharge
silent brain infarctionssix yearsnumber of patients in whom asymptomatic ischemic infarctions are identified in brain scans (CTC or MRI)
occurrence of atrial fibrillation during follow-upten years

Countries

Denmark

Contacts

Primary ContactHelena DOMINGUEZ, MD, PhD
mdom0002@regionh.dk4522989343
Backup ContactIda Gustafsson, MD, PhD
ida.gustafsson@regionh.dk4538635000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026