Discontinuing anticoagulants after heart surgery for atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Gentofte Hospital
  Gentofte Municipality, Capital Region, Denmark Recruiting
• Århus Universitetshospital
  Aarhus, Region Midt, Denmark Recruiting
• Odense University Hospital
  Odense, Region Syddanmark, Denmark Recruiting
• Rigshospitalet
  Copenhagen, Capital Region, Denmark Not yet recruiting
• Regionshospital Gødstrup
  Herning, Central Jutland, Denmark Not yet recruiting
• Aalborg university hospital
  Aalborg, North Denmark, Denmark Not yet recruiting

Study contacts

• Principal investigator: Lars Peter Riber, DMSc — Odense University Hospital
• Study coordinator: Kristina Gosvig, M.D.
• Email: kristina.gosvig@rsyd.dk
• Phone: +4551520696

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.