AXAFA

Study design

Investigator-driven, prospective, parallel-group, randomised, open, Blinded Outcome Assessment (PROBE),multi-centre trial to determine the optimal anticoagulation therapy for patients undergoing catheter ablation of atrial fibrillation

Inclusion Criteria

Non-valvular AF (ECG-documented) with a clinical indication for catheter ablation

Clinical indication to undergo catheter ablation on continuous anticoagulant therapy

Presence of at least one of the CHADS2 stroke risk factors

• Stroke or TIA
• age ≥ 75 years,
• hypertension, defined as chronic treatment for hypertension, estimated need for continuous antihypertensive therapy or resting blood pressure > 145/90 mm Hg,
• diabetes mellitus,
• symptomatic heart failure (NYHA ≥ II).

Age ≥ 18 years

Provision of signed informed consent

General exclusion criteria

Any disease that limits life expectancy to less than 1 year

Participation in another clinical trial, either within the past two months or still ongoing

Previous participation in AXAFA

Pregnant women or women of childbearing potential not on adequate birth control: only women with a highly effective method of contraception (oral contraception or intra-uterine device) or sterile women can be randomised.

Breastfeeding women

Drug abuse or clinically manifest alcohol abuse

Any stroke within 14 days before randomisation

Coadministration with drugs that are strong dual inhibitors of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) or strong dual inducers of CYP3A4 and P-gp (Appendix VIII).

Exclusion criteria related to a cardiac condition

Valvular AF (as defined by the focussed update of the ESC guidelines on AF, i.e. severe mitral valve stenosis, mechanical heart valve). Furthermore, patients who underwent mitral valve repair are not eligible for AXAFA.

Any previous ablation or surgical therapy for AF

Cardiac ablation therapy for any indication (catheter-based or surgical) within 3 months prior to randomisation

Clinical need for “triple therapy” (combination therapy of clopidogrel, acetylsalicylic acid, and oral anticoagulation

Other contraindications for use of VKA or apixaban

Documented atrial thrombi less than 3 months prior to randomisation

Exclusion criteria based on laboratory abnormalities

Severe chronic kidney disease with an estimated glomerular filtration rate (GFR) < 15 ml/min