Can Patients With Atrial Fibrillation Safely Discontinue Anticoagulant Therapy After Cardiac Surgery? (ATLAAC)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorOdense University Hospital
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- OAC will be discontinued for the duration of the trial
Treatment groups
1,220 Participants
are divided into 2 treatment groupsSponsors and collaborators
Odense University Hospital
Lead sponsor
Rigshospitalet, Denmark
Collaborator
Gødstrup Hospital
Collaborator
Aarhus University Hospital
Collaborator
Aalborg University Hospital
Collaborator
Population Health Research Institute
Collaborator
Region of Southern Denmark
Collaborator
Source ClinicalTrials.gov