Non-valvular atrial fibrillation with a clinical indication for catheter ablation/bleeding + stroke risk/cardiology Circulatory System Atrial fibrillation
Conditions
Interventions
Anticoagulation therapy with new oral anticoagulants and vitamin-k-antagonists during atrial fibrillation ablation
Sponsors
Kompetenznetz Vorhofflimmern e.V. (AFNET) [Atrial Fibrillation NETwork]
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Non-valvular AF (ECG-documented) with a clinical indication for catheter ablation 2. Clinical indication to undergo catheter ablation on continuous anticoagulant therapy 3. Presence of at least one of the CHADS2 stroke risk factors 3a. Stroke or TIA 3b. Age =75 years 3c. Hypertension, defined as chronic treatment for hypertension, estimated need for continuous antihypertensive therapy or resting blood pressure >145/90 mm Hg 3d. Diabetes mellitus 3e. Symptomatic heart failure (NYHA =II) 4. Age =18 years 5. Provision of signed informed consent
Exclusion criteria
Exclusion criteria: General exclusion criteria 1. Any disease that limits life expectancy to less than 1 year 2. Participation in another clinical trial, either within the past two months or still ongoing 3. Previous participation in AXAFA 4. 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. 5. Breastfeeding women 6. Drug abuse or clinically manifest alcohol abuse Added 18/10/2017: 7. Any stroke within 14 days before randomisation 8. 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 9. 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. 10. Any previous ablation or surgical therapy for AF 11. Cardiac ablation therapy for any indication (catheter-based or surgical) within 3 months prior to randomisation 12. Clinical need for ?triple therapy? (combination therapy of clopidogrel, acetylsalicylic acid, and oral anticoagulation) 13. Other contraindications for use of VKA or apixaban Exclusion criteria based on laboratory abnormalities 14. Severe chronic kidney disease with an estimated glomerular filtration rate (GFR) <15 ml/min Added 18/10/2017: 15. Documented atrial thrombi less than 3 months prior to randomisation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A composite of 1. All-cause death 2. Stroke (ischemic stroke, subarachnoid hemorrhage and hemorrhagic stroke) 3. Major bleeding events, defined as BARC 2 or higher | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Any bleeding event 2. Major bleeding events according to the ISTH and TIMI definitions 3. Number of strokes, other systemic embolic events, and all-cause deaths 4. Time from randomisation to ablation 5. Nights spent in hospital after ablation 6. Health-care related cost calculation 7. Number of hospitalizations for cardiovascular reasons 8. Treatment duration prior to ablation and total time on oral anticoagulation 9. Number of patients with clinically indicated TEE 10. ACT during ablation 11. Time to recurrent AF 12. Rhythm status at the end of follow-up 13. Vascular access complications leading to prolongation of in-hospital stay or specific therapy 14. Quality-of-life changes at month 3 compared to baseline 15. Cognitive function change at month 3 compared to baseline Updated 18/10/2017: 16. MRI sub-study, only: Prevalence of clinically “silent” MRI-detected brain lesions within 48 hours after the ablation procedure 17. MRI sub-study, only: Impact of ablation-associated clinically overt strokes or MRI-detected but clinically “silent” acute brain lesions on cognitive function after ablation | — |
Countries
Austria, Belgium, Denmark, Germany, Italy, Netherlands, Spain, United Kingdom, United States of America
Outcome results
None listed