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

ConditionsAtrial Fibrillation Left Atrial Appendage Absent Anticoagulant Adverse Reaction

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

OAC will be discontinued for the duration of the trial
Drug
Discontinuation of warfarin, dabigatran, rivaroxaban, apixaban or edoxaban

Treatment groups

1,220 Participants

are divided into 2 treatment groups

Group A: Discontinue OACExperimental treatment 1 intervention

Group B: Continue OACNo intervention 0 interventions

Trial outcomes

Primary outcomes

Number of participants with ischemic strokes, peripheral arterial embolisms and major bleedings

Composite endpoint including the occurrence of ischemic stroke, peripheral arterial embolism, and major bleeding (ISTH definition)

Time frame