Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II - ORBIT AF II - Phase II of the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (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.

  • STATUS
    Recruiting
Updated on 8 November 2020

Summary

Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II - ORBIT AF II - Phase II of the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (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.

Description

The goal of this US prospective outpatient AF registry is to identify real world treatment patterns in patients with AF(atrial fibrillation), outside of randomized controlled trials. Specifically, the registry will attempt to define current treatment patterns and their relationship with outcomes, including stroke, all-cause mortality, and quality-of-life.

Details
Clinical Study IdentifierTX137593
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Be an adult, 21 years of age or older
Have electrocardiographically confirmed AF
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
AND OTHERS

Exclusion Criteria

Have atrial flutter only
Have an anticipated life expectancy less than 6 months
Have transient AF secondary to a reversible condition (eg, hyperthyroidism, pulmonary embolism, post-cardiothoracic surgery)
Is participating in a randomized clinical study of any anticoagulation for AF at the time of enrollment
Was enrolled in the ORBIT-AF I registry
AND OTHERS
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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