Left Atrial Appendage Arrhythmogenic and Thrombogenic Substrate
NCT ID: NCT06405750
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1000 participants
INTERVENTIONAL
2024-08-01
2035-12-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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LAA closure
All patients included in the study undergo closure of the Left Atrial Appendage
left atrial appendage closure
systematic closure of the left atrial appendage in addition to the planned heart surgery
Interventions
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left atrial appendage closure
systematic closure of the left atrial appendage in addition to the planned heart surgery
Eligibility Criteria
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Inclusion Criteria
* planned any open-heart surgery:
* CABG
* valve repair or replacement
* aorta surgery
* any combination of the above
Exclusion Criteria
* follow-up not possible
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
University of Copenhagen
OTHER
University Hospital Bispebjerg and Frederiksberg
OTHER
Responsible Party
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Helena DOMINGUEZ
MD, PhD, Associate Professor
Principal Investigators
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Helena Dominguez
Role: STUDY_DIRECTOR
University Hospital Bispebjerg and Frederiksberg
Locations
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Rigshospitalet
Copenhagen, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Christian L Carranza
Role: primary
Other Identifiers
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P-2023-227
Identifier Type: OTHER
Identifier Source: secondary_id
H-23015282
Identifier Type: -
Identifier Source: org_study_id