Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF)
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      The ORBIT-AF registry will be a multicenter, prospective outpatient disease registry to
      identify "real world" treatment patterns of atrial fibrillation. The registry will describe
      this patient population with regards to demographics, clinical factors, risk stratification,
      and geographic regions. In particular, attention will be focused on the utilization,
      effectiveness, and safety of antithrombotic therapies in the prevention of stroke. The
      registry is designed to identify reasons and risk factors for non-receipt of anticoagulation
      (AC) therapy, as well as reasons why AF patients who are prescribed AC therapy do not take
      them.
    

Detailed description: 
      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)
    

Intervention name(s): Patients with Atrial Fibrillation (AF)
Intervention type(s): Other
Intervention description(s): Treatment patterns of AF according to patient demographics, clinical factors, risk stratification, and geographic regions.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Enrolling physicians will include cardiologists, internists, and electrophysiologists from
        both academic and private practice who preferably have experience in registry
        participation.
      
Keywords: Irregular heart beat