Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401616
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-03-05
Brief Title:
Can Patients With Atrial Fibrillation Safely Discontinue Anticoagulant Therapy After Cardiac Surgery ATLAAC
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Anticoagulant Therapy in Patients With Atrial Fibrillation After Surgical Left Atrial Appendage Closure a Randomized Non-inferiority Trial The ATLAAC Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
Left atrial appendage LAA closure has become a frequent addition to oral anticoagulation in patients with atrial fibrillation who undergo cardiac surgery The procedure significantly reduces the risk of stroke and systemic embolism which may render anticoagulation unnecessary or even harmful when considering the associated increased risk of bleeding A clinical trial to address the need for anticoagulation after LAA closure is needed
The ATLAAC trial will enroll 1220 patients with atrial fibrillation who have previously undergone surgical LAA closure Patients will undergo a cardiac CT-scan to determine if LAA closure was successful and patients with successful closure will be randomized to continue or discontinue anticoagulation The trial will assess the risk of ischemic stroke peripheral arterial embolism and major bleeding during the randomized intervention
The ATLAAC trial will enroll 1220 patients with atrial fibrillation who have previously undergone surgical LAA closure Patients will undergo a cardiac CT-scan to determine if LAA closure was successful and patients with successful closure will be randomized to continue or discontinue anticoagulation The trial will assess the risk of ischemic stroke peripheral arterial embolism and major bleeding during the randomized intervention
Detailed Description:
None
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 |
|---|---|---|---|
| 2022-502986-92-00 | OTHER | EU-CT | None |