Related Experiment Video
Updated: Jun 13, 2025
Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
Published on: February 26, 2013
Rationale and design of the anticoagulant therapy after left atrial appendage closure (ATLAAC) trial
Kristina Gosvig1, Julie Goller1, Nils Henrik Hansson2
1Department of Cardiothoracic and Vascular Surgery, Odense University Hospital, Odense, Denmark; Department of Clinical Research, Research unit for Cardiac Surgery, University of Southern Denmark, Odense, Denmark.
Insights
This study investigates if stopping oral anticoagulation (OAC) is safe after left atrial appendage closure (LAAC) in atrial fibrillation patients. The ATLAAC trial aims to determine if OAC cessation is non-inferior to continuation for preventing major adverse events.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Left atrial appendage closure (LAAC) is recommended for atrial fibrillation patients undergoing cardiac surgery to reduce stroke risk.
- The use of oral anticoagulation (OAC) post-LAAC is debated due to potential increased bleeding risks.
- This trial evaluates the safety of discontinuing OAC after successful surgical LAAC.
Purpose of the Study:
- To test the hypothesis that stopping OAC is non-inferior to continuing OAC after surgical LAAC.
- To assess the primary endpoint of ischemic stroke, systemic arterial embolism, or major bleeding.
- To evaluate secondary endpoints including mortality, bleeding events, and quality of life.
Main Methods:
- The ATLAAC trial is a multicenter, randomized, controlled study enrolling 1,220 patients with atrial fibrillation post-surgical LAAC.
- Successful LAAC is confirmed by cardiac CT scan before randomization.
- Patients are randomized to either stop or continue OAC, with follow-up for a primary composite endpoint over 4 years.
Main Results:
- Enrollment began March 2024; 554 patients enrolled and 319 randomized as of January 2025.
- Recruitment is ongoing, expected to continue for another 12 months.
- The study will conclude once 128 primary endpoints have occurred.
Conclusions:
- The ATLAAC trial is designed to provide crucial data on the safety of stopping OAC post-surgical LAAC.
- Results will inform clinical practice regarding OAC management in this patient population.
Introduction:
Left atrial appendage closure (LAAC) has become a recommended addition to oral anticoagulation for patients with atrial fibrillation, who undergo cardiac surgery. The procedure significantly reduces the risk of stroke and systemic arterial embolism, potentially making oral anticoagulation (OAC) unnecessary or even harmful, when considering the associated increased risk of bleeding. This publication describes the rationale and design of a randomized trial, testing the hypothesis that stopping OAC is noninferior to continuing OAC after surgical LAAC in terms of the primary endpoint.
Methods:
The ATLAAC trial is a multicenter, randomized, controlled trial, aiming to enroll 1,220 patients with atrial fibrillation, who have undergone surgical LAAC and remain on OAC. A cardiac CT scan is performed to confirm success of the LAAC. Patients with successful closure are randomized to stop or continue OAC. The primary endpoint is the first occurrence of ischemic stroke, systemic arterial embolism, or major bleeding over an expected mean follow-up of 4 years. Secondary endpoints include all-cause mortality, cardiovascular mortality, any bleeding leading to hospitalization, blood transfusion, venous thromboembolism, myocardial infarction, and quality of life measures.
Trial Status:
Enrollment for the ATLAAC trial began in March 2024. As of January 18th, 2025, 554 patients have been enrolled in the study and 319 patients have been randomized. Recruitment is expected to continue for approximately 12 months. Follow-up will be stopped once 128 primary endpoints have occurred.
Conclusions:
The ATLAAC trial will evaluate the safety of stopping OAC after surgical LAAC.
Trial Registration Number:
EU-CT: 2022-502986-92-00, clinicaltrials.gov ID: NCT06401616.
