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

Odense University Hospital

Status and phase: Enrolling; Phase 4

Conditions: Atrial Fibrillation; Anticoagulant Adverse Reaction; Left Atrial Appendage Absent

Treatments: Drug: OAC will be discontinued for the duration of the trial

Study type: Interventional

Funder types: Other

Identifiers

NCT06401616

2022-502986-92-00 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 1,220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,220 participants in 2 patient groups

Discontinue OAC

Experimental group

Description:

OAC stopped for the duration of the trial

Treatment:

Drug: OAC will be discontinued for the duration of the trial

Continue OAC

No Intervention group

Description:

OAC continued for the duration of the trial