A Study Exploring Two Treatment Strategies in Patients With Atrial Fibrillation Who Undergo Catheter Ablation Therapy (VENTURE-AF)

• Incidence of post-procedure major bleeding events [ Time Frame: During the first 30 ± 5 days after the catheter ablation procedure ] [ Designated as safety issue: Yes ]
  

• Event rate of the composite endpoint of myocardial infarction (MI), ischemic stroke, non-Central Nervous System (non-CNS) systemic embolism and vascular death [ Time Frame: During the 30 ± 5 days after the catheter ablation procedure ] [ Designated as safety issue: Yes ]
  
• Event rate of myocardial infarction (MI) [ Time Frame: During the 30 ± 5 days after the catheter ablation procedure ] [ Designated as safety issue: Yes ]
  
• Event rate of ischemic stroke [ Time Frame: During the 30 ± 5 days after the catheter ablation procedure ] [ Designated as safety issue: Yes ]
  
• Event rate of non-Central Nervous System (non-CNS) systemic embolism [ Time Frame: During the 30 ± 5 days after the catheter ablation procedure ] [ Designated as safety issue: Yes ]
  
• Event rate of vascular death [ Time Frame: During the 30 ± 5 days after the catheter ablation procedure ] [ Designated as safety issue: Yes ]
  

This is a randomized (participants are assigned to intervention groups by chance), open-label (all involved people know the identity of the intervention), active-controlled, multi-center clinical study of rivaroxaban or VKA before and after a catheter ablation procedure. This study requires collaboration with medical institutions that provide access to electrophysiologists who normally perform the catheter ablation procedure. In order to achieve 200 per-protocol participants, approximately 250 eligible participants, age 18 years or older, with a history of paroxysmal or persistent NVAF who are scheduled to undergo their first elective catheter ablation procedure will be randomized in a 1:1 ratio to receive either rivaroxaban 20 mg orally, once daily, preferably administered with the evening meal or uninterrupted VKA (adjusted to achieve a recommended INR of 2.0 to 3.0). In this study, NVAF is to be defined as the presence of AF in a person who does not have a prosthetic heart valve (annuloplasty with or without prosthetic ring, commissurotomy and/or valvuloplasty are permitted) and who does not have hemodynamically significant mitral valve stenosis. The screening period will begin up to 2 weeks prior to randomization. The study will include scheduled visits and telephone calls and may also include additional phone calls and visits by the participant to the site when dose adjustment is required for usual care.