Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF)

The ORBIT-AF registry is a multicenter prospective outpatient disease registry of patients
with incident (initial diagnosis) or prevalent (existing diagnosis) atrial fibrillation (AF)
that will analyze treatment patterns and outcomes in patients with AF in the US.
Approximately 10,000 prospective cohort of patients will be enrolled. The registry will be a
nation-wide collaboration of Health Care Providers (e.g., cardiologists, internists, primary
care physicians, electrophysiologists, quality improvement personnel, office/practice
managers, research coordinators, and pharmacists). This collaborative effort will be focused
on the optimization of outpatient management of patients with AF. Consecutive patients who
meet the eligibility criteria will be approached and educated about the registry. Patients
who express interest will provide informed consent. Patients enrolled in the registry will
be followed for approximately 3 years. Patient follow-up by their AF care provider will
continue as scheduled according to local clinical practice. Patient Reported outcome (PRO)
questionnaires will be administered to a sub-sample of approximately 1,500 patients. For
patients who consent to answer PRO questionnaires, these questionnaires will be administered
by the site to the patient at the baseline visit [except the baseline
Anticoagulation-Related Treatment Satisfaction (ACTS)] and during their regularly scheduled
follow-up visits. The baseline ACTS for incident patients will be completed and returned
back to the site at least 4 weeks after starting antithrombotic therapies. The ACTS
questionnaire will only be administered to patients who are taking antithrombotic therapies
within the 4 weeks before a visit or newly prescribed antithrombotic therapies. Data
collection will occur at 6-month intervals for a minimum of 3 years (baseline, 6 months, 12
months, 18 months, 24 months, 30 months, and 36 months). The data collection windows will be
wide (3 months in either direction) in order to maximize data collection during the patients
regularly scheduled follow-up with their AF care provider. Collection of Patient Reported
Outcome (PRO) Questionnaires will not continue beyond the 24-month data collection interval.
Atrial Fibrillation Data capture will include demographics, cardiovascular risk factors,
diagnosis, type of AF (paroxysmal, persistent, permanent AF), treatment strategy (rate vs.
rhythm), ablation history, cardioversions, antithrombotic therapy decisions and monitoring
(INRs), concomitant medications and doses, insurance and provider information, AF
quality-of-life, anticoagulation treatment satisfaction, caregiver assistance, pet
ownership, comorbidities, compliance, and outcomes. Pre-defined outcomes of interest will
include stroke or non-CNS (non-systemic) embolism, major adverse cardiac events, all-cause
mortality, cause-specific death (sudden, non-sudden, heart failure-related), major bleeding,
AF-related quality of life, anticoagulation-related treatment satisfaction, all-cause
hospitalization and specific anticoagulation outcomes (e.g. time in therapeutic range and
primary discontinuation of oral anticoagulation). The data generated by this registry will
be used to identify real world practice, especially as it compares and relates to guidelines
set forth by the American College of Cardiology, American Heart Association and European
Society of Cardiology for the management of patients with AF. Observational Study - No
investigational drug administered. For any patients receiving the sponsor's drug, Xarelto
(rivaroxaban), under the direction of a physician, all serious adverse events and all
non-serious related events will be reported to the sponsor (Janssen Scientific Affairs, LLC)

Inclusion Criteria:

- Adult patients with incident (initial diagnosis) or prevalent (existing diagnosis) AF
with electrocardiographic documentation

- anticipated ability to adhere to local regularly scheduled follow-up visits

Exclusion Criteria:

- Anticipated life expectancy less than 6 months

- short lasting AF secondary to a reversible condition (e.g. hyperthyroidism, pulmonary
embolism, post-cardiothoracic surgery)

- Participation in a randomized trial of anticoagulation for AF at the time of
enrollment