Left Atrial Appendage Arrhythmogenic and Thrombogenic Substrate

Stroke Clinical Trial

— LAATAS  

Official title:

Left Atrial Appendage Arrhythmogenic and Thrombogenic Substrate

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06405750
• Other study ID #: H-23015282
• Secondary ID: P-2023-227
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 10, 2024
• Est. completion date: December 31, 2035

Study information

• Verified date: June 2024
• Source: University Hospital Bispebjerg and Frederiksberg
• Contact: Helena DOMINGUEZ, MD, PhD
• Phone: 4522989343
• Email: mdom0002[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2035
• Est. primary completion date: December 31, 2035
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Bispebjerg and Frederiksberg	Rigshospitalet, Denmark, University of Copenhagen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stroke	number of patients with clinical stroke	six years
Secondary	perioperative atrial fibrillation	number of patients with incident atrial fibrillation the days after surgery, prior to discharge	30 days
Secondary	silent brain infarctions	number of patients in whom asymptomatic ischemic infarctions are identified in brain scans (CTC or MRI)	six years