Left Atrial Appendage Arrhythmogenic and Thrombogenic Substrate
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: left atrial appendage closure.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation, Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Procedure left atrial appendage closure
systematic closure of the left atrial appendage in addition to the planned heart surgery
Primary outcome measures
- stroke [Time frame: six years]
Secondary outcome measures (3)
- perioperative atrial fibrillation [Time frame: 30 days]
- silent brain infarctions [Time frame: six years]
- occurrence of atrial fibrillation during follow-up [Time frame: ten years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Denmark · 1 center
- Rigshospitalet — Copenhagen
Identifiers
NCT: NCT06405750 · H-23015282 · P-2023-227