Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06405750
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-05
Brief Title:
Left Atrial Appendage Arrhythmogenic and Thrombogenic Substrate
Sponsor:
University Hospital Bispebjerg and Frederiksberg
Organization:
University Hospital Bispebjerg and Frederiksberg
Study Overview
Official Title:
Left Atrial Appendage Arrhythmogenic and Thrombogenic Substrate
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LAATAS
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P-2023-227 | OTHER | Capital Region Denmark | None |