Clinical Trial

Can Patients With Atrial Fibrillation Safely Discontinue Anticoagulant Therapy After Cardiac Surgery? (ATLAAC)

Recruiting Phase 4
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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
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-05-03; most recent amendment 2024-05-22.
Status change: Not Yet Recruiting → Recruiting 2024-05-22
Status change: Recruiting → Not Yet Recruiting 2024-05-17
Trial Details
NCT Number NCT06401616
Lead Sponsor Odense University Hospital
Collaborators: Rigshospitalet, Denmark, Gødstrup Hospital, Aarhus University Hospital, Aalborg University Hospital, Population Health Research Institute, Region of Southern Denmark
Conditions Atrial Fibrillation, Left Atrial Appendage Absent, Anticoagulant Adverse Reaction
Enrollment 1,220 participants
Start Date 2024-05-21
Primary Completion 2028-03 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2024-05-23