Discontinuing anticoagulants after heart surgery for atrial fibrillation

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

This study is testing if people with atrial fibrillation can safely stop taking blood thinners after having surgery to close a part of their heart, to see if it helps avoid bleeding problems.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1220 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Odense University Hospital (Academic / other)
• Locations: 6 sites (Copenhagen, Capital Region and 5 other locations)
• Trial ID: NCT06401616 on ClinicalTrials.gov

What this trial studies

The ATLAAC trial investigates whether patients with atrial fibrillation can safely stop anticoagulant therapy after undergoing surgical closure of the left atrial appendage (LAA). It will enroll 1220 patients who have had LAA closure and assess the success of the procedure using cardiac CT scans. Participants will be randomized to either continue or discontinue anticoagulation therapy, with the study measuring outcomes such as ischemic stroke, peripheral arterial embolism, and major bleeding. This approach aims to determine if anticoagulation is necessary post-surgery, potentially reducing the risk of bleeding complications.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 who have undergone surgical LAA closure and have a documented history of atrial fibrillation.

Not a fit: Patients who are not currently receiving anticoagulants or have conditions requiring ongoing anticoagulation will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help identify patients who can safely discontinue anticoagulants, reducing their risk of bleeding without increasing the risk of stroke.

How similar studies have performed: Other studies have explored anticoagulation management post-LAA closure, but this specific approach is novel and aims to provide clearer guidance on anticoagulant therapy after surgery.

Eligibility criteria

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

Where this trial is running

Copenhagen, Capital Region and 5 other locations

• 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)

Study contacts

• Principal investigator: Lars Peter Riber, DMSc — Odense University Hospital
• Study coordinator: Kristina Gosvig, M.D.

Conditions Atrial Fibrillation; Left Atrial Appendage Absent; Anticoagulant Adverse Reaction; Atrial fibrillation; Anticoagulant treatment; Surgical left atrial appendage closure; surgical left atrial appendage occlusion