RECRUITINGPhase 4INTERVENTIONAL

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

Anticoagulant Therapy in Patients With Atrial Fibrillation After Surgical Left Atrial Appendage Closure: a Randomized Non-inferiority Trial (The ATLAAC Trial)

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 - willing to sign a consent form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

OAC will be discontinued for the duration of the trial

Discontinuation of warfarin, dabigatran, rivaroxaban, apixaban or edoxaban

Locations (6)

Rigshospitalet

Copenhagen, Capital Region, Denmark

Gentofte Hospital

Gentofte Municipality, Capital Region, Denmark

Regionshospital Gødstrup

Herning, Central Jutland, Denmark

Aalborg university hospital

Aalborg, North Denmark, Denmark

Århus Universitetshospital

Aarhus, Region Midt, Denmark

Odense University Hospital

Odense, Region Syddanmark, Denmark