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

RecruitingPhase 4Ages 18 Years - anyAllOdense University Hospital
NCT06401616 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age \> 18 years * Previously undergone any type of cardiac surgical procedure including any type of surgical LAA closure (use of any of the following techniques; amputation and suture closure, stapler closure, non-amputating suture closure or closure with an approved surgical occlusion device (e.g. AtriClip)) according to the NationalPatient Register (NPR), the Danish Heart Registry (DHR) or the Western Danish Heart Registry (WDHR) from January 1st 2010 til 3 months prior to inclusion in the project. * Documented history of paroxysmal, persistent, or permanent atrial fibrillation or atrial flutter according to the electronic patient record * Informed consent Exclusion Criteria: * Not receiving OAC (warfarin/DOAC) * Patient specific conditions requiring OAC (e.g.mechanical valve, previous pulmonary embolism) * Renal impairment (estimated glomerular filtration rate \< 30) * Allergy to contrast media * Pregnancy or breastfeeding
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What it tests

  • OAC will be discontinued for the duration of the trial
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Where

6 sites
Rigshospitalet
Copenhagen, Denmark
Gentofte Hospital
Gentofte Municipality, Denmark
Regionshospital Gødstrup
Herning, Denmark
Aalborg university hospital
Aalborg, Denmark
Århus Universitetshospital
Aarhus, Denmark
Odense University Hospital
Odense, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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