A Study Exploring Two Treatment Strategies in Patients With Atrial Fibrillation Who Undergo Catheter Ablation Therapy

This is a randomized (participants are assigned to intervention groups by chance),
open-label (both physicians and participants know the identity of the assigned treatment),
active-controlled, multi-center safety 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 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. Approximately 250 eligible participants, age 18 years or
older, with a history of paroxysmal, persistent, or long standing persistent NVAF who are
scheduled to undergo an elective catheter ablation procedure will be randomized in a 1:1
ratio to receive either rivaroxaban 20 mg orally, once-daily, administered preferably with
the evening meal or VKA (adjusted to achieve a recommended International Normalized Ratio of
2.0 to 3.0).

The study will consist of a screening period, a pre-procedure period, procedure period and
post-procedure period. The screening period will begin up to 2 weeks prior to randomization.
Participants will be randomized at the beginning of the pre-procedure period. During this
period, participants will be recommended to receive their assigned treatment for at least 4
weeks (maximum of 5 weeks) before the catheter ablation procedure. For participants with the
sufficient anticoagulation, documented for the 3 weeks prior to randomization, and for
participants with a transesophageal echocardiogram (TEE) or intracardiac echocardiography
(ICE), the length of the pre-procedure period may be reduced down to 1-7 days and must
include any transition from the previous anticoagulation therapy to randomized study drug.

After the catheter ablation procedure, participants will receive their post-procedure dose
of study drug through a minimum of 30 + - 5 days. In addition to scheduled visits and
telephone calls the study may also include additional phone calls and visits by the
participant to the site when dose adjustment is required for usual care.

Inclusion Criteria:

- Be scheduled for a catheter ablation procedure for non-valvular atrial fibrillation
(NVAF);

- Have a documented history of paroxysmal (lasting <1 week) or persistent (lasting >1
week and <1 year or requiring pharmacological or electrical cardioversion), or long
standing persistent (>=1 year) NVAF;

- Be suitable for anticoagulant therapy and catheter ablation as per the judgment of
the investigator;

- Women must be postmenopausal before entry or practicing a highly effective method of
birth control when heterosexually active;

- Women of childbearing potential must have a negative serum pregnancy test at
screening;

- Be willing and able to adhere to the prohibitions and restrictions specified in the
study protocol;

- Have a life expectancy of at least 6 months

Exclusion Criteria:

- Has a history of a prior stroke, transient ischemic attack (TIA) or non-convulsive
status epilepticus within 6 months of the screening visit;

- Has a history of a major bleeding or thromboembolic event within the 12 months
immediately preceding the catheter ablation procedure;

- Has had major surgery (requiring general anesthesia), within 6 months before
screening or planned surgery during the time the subject is expected to participate
in the study;

- Has NVAF due to electrolyte imbalance, hyperthyroidism, or other reversible or
noncardiac cause of NVAF;

- Has any condition that, in the opinion of the investigator, would make participation
not be in the best interest (eg, compromise the well-being) of the participant or
that could prevent, limit, or confound the protocol-specified assessments