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

Phase 4RecruitingNCT06401616

Odense University Hospital1,220 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

1,220

Conditions

Atrial Fibrillation Left Atrial Appendage Absent Anticoagulant Adverse Reaction

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Rigshospitalet

Copenhagen, Capital Region, Denmark

NOT_YET_RECRUITING

Gentofte Hospital

Gentofte Municipality, Capital Region, Denmark

RECRUITING

Regionshospital Gødstrup

Herning, Central Jutland, Denmark

NOT_YET_RECRUITING

Aalborg university hospital

Aalborg, North Denmark, Denmark

NOT_YET_RECRUITING

Århus Universitetshospital

Aarhus, Region Midt, Denmark

RECRUITING

Odense University Hospital

Odense, Region Syddanmark, Denmark

RECRUITING

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)