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

  •   Contact:
    Rhode Island Hospital
    Cardiac Projects Office 
    401-444-5324

    Background: Atrial fibrillation (AF) is the most common arrhythmia, affecting 1% of the United States general population. The incidence and prevalence of AF increases with age, such that approximately 1 in 10 patients over the age of 80 has AF. As the population continues to age, it is expected that more than 3 million persons in the United States will have AF by 2020. In addition, the risk of AF-related stroke increases with age.  In its first phase, the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation, or ORBIT-AF (ORBIT-AF I), successfully enrolled more than 10,000 patients with AF across the United States. The ORBIT-AF I registry was designed to characterize the contemporary pharmacoepidemiology, management, and outcomes associated with AF.

     The enrollment period of the ORBIT-AF I registry was from June 2010 to August 2011; the 3-year data collection period is currently ongoing. Phase II of the ORBIT-AF registry (ORBIT-AF II) is designed to evaluate the utilization of target-specific antithrombotic agents, such as factor Xa (FXa) inhibitors and direct thrombin inhibitors, and associated outcomes. Importantly, the ORBIT-AF II registry will permit the collection and analysis of post-approval observational data needed for evaluating the outcomes associated with these new agents when used in broader patient populations outside of clinical studies. The ORBIT-AF II registry will focus on patients with newly diagnosed AF as well as those who have been recently started on a target-specific oral anticoagulant agent. Taken together, the ORBIT-AF I and ORBIT-AF II registries will offer a broad and contemporary view of AF therapy.

    Objective:
    The primary objective is to evaluate the safety of target-specific oral anticoagulant agents, including FXa inhibitors and direct thrombin inhibitors, in patients with AF.

    The secondary objectives are:

    • To evaluate clinical outcomes associated with the use of target-specific oral anticoagulant agents in patients with AF.
    • To document the anticoagulation treatment patterns and clinical course of patients with AF who undergo cardiac procedures.
    • To describe patient characteristics, including stroke, bleeding risk strata, and characteristics associated with specific subpopulations of patients with AF, including patients with new-onset/first-detected AF, heart failure, acute coronary syndrome, and chronic kidney disease.
    • To summarize the frequency and reasons for discontinuation and switching between oral antithrombotic agents in patients with AF.

    Inclusion Criteria:
    Each potential patient must satisfy all of the following criteria to be enrolled in the registry. Each patient must:
    1. Be an adult, 21 years of age or older.
    2. Have electrocardiographically confirmed AF.
    3. Have 1 of the following:
    •    New-onset/first-detected AF diagnosed within the 6 months preceding the baseline visit
    OR
    •    Initiated or transitioned to a FXa inhibitor or a direct thrombin inhibitor within the 3 months preceding the baseline visit.
    4. Have anticipated ability to adhere to local regular semiannual follow-up outpatient visits.
    5. Sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the registry.

    Exclusion Criteria:
    Any potential patient who meets any of the following criteria will be excluded from participating in the registry. The patient will be excluded if he or she:
    1. Have atrial flutter only.
    2. Have an anticipated life expectancy less than 6 months.
    3. Have transient AF secondary to a reversible condition (e.g., hyperthyroidism, pulmonary embolism, post-cardiothoracic surgery).
    4. Is participating in a randomized clinical study of any anticoagulation for AF at the time of enrollment.
    5. Was enrolled in the ORBIT-AF I registry.
    6. Is an employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as immediate family members of the employee or the investigator.