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

The registry will be used to evaluate, describe, and document the safety of target-specific
anticoagulant agents (and other antithrombotic agents) in patients with Atrial Fibrillation
(AF), the clinical outcomes associated with their use, the treatment patterns and clinical
course of patients with AF, including those who undergo cardiac procedures of interest
(ablation, cardioversion, catheterization and surgery, for examples), and characteristics of
patients with new onset/first-detected AF. Additionally, the registry will be used to
summarize patterns of switching or discontinuation of antithrombotic agents in the United
States. The registry will be a nationwide collaboration of health care providers (eg,
cardiologists, internists, primary care physicians, electrophysiologists, quality improvement
personnel, office/practice managers, research coordinators, and pharmacists). Target
enrollment will be approximately 15,000 patients. It is anticipated that enrollment will
complete in approximately 3.5 years. 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 up to 2
years. New patients enrolled in the registry will be followed for up to 1 year. Patient
follow-up by their AF care provider will continue as scheduled according to local clinical
practice. Data collection will occur at 6 month intervals for approximately 1 year from the
time of enrollment of the patient (baseline, 6, and 12 months). Data capture will include
demographics, medical history, cardiovascular history, vital signs, echocardiographic and
laboratory data, AF status and type (paroxysmal, persistent, long-standing
persistent/permanent), pharmacotherapy, contraindications to oral anticoagulant therapy, and
provider specialty. Clinical outcomes and safety data capture will include major adverse
cardiac events (MACEs).

Inclusion Criteria: - Adult patients with incident (initial diagnosis) AF (Atrial
Fibrillation) with electrocardiographic documentation or patients with prevalent (existing
diagnosis) AF who had initiation or transition to a FXa (Factor Xa) inhibitor or a direct
thrombin inhibitor within the preceding 3 months - anticipated ability to adhere to local
regularly scheduled follow-up visits

Exclusion Criteria:

- Atrial flutter only - 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 - Was enrolled in the ORBIT-I Registry