A Registry for Evaluating the Outcomes Associated with New Drug Treatments for Atrial Fibrillation, as Used in Broad Populations Outside of Clinical Trials

Overview

About this study

The purpose of this registry is to collect observational data for evaluating the outcomes related to the use of new target-specific antithrombotic agents, such as FXa (factor Xa) inhibitors and direct thrombin inhibitors, as they are used in broad patient populations following approval by clinical research studies. The ORBIT-AF II registry will focus on patients with newly diagnosed atrial fibrillation (AF) as well as those who have been recently started on a target-specific oral anticoagulant agent.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Adult patients with initial diagnosis of Atrial Fibrillation, with electrocardiographic documentation
Patients with an existing diagnosis of AF who had initiation or transition to an 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

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Clinical Trials