Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF)
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ClinicalTrials.gov Identifier: NCT01165710 |
Recruitment Status :
Completed
First Posted : July 20, 2010
Last Update Posted : January 24, 2017
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Condition or disease | Intervention/treatment |
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Atrial Fibrillation | Other: Patients with Atrial Fibrillation (AF) |
Study Type : | Observational |
Actual Enrollment : | 10179 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) |
Study Start Date : | June 2010 |
Actual Primary Completion Date : | November 2014 |
Actual Study Completion Date : | December 2014 |

Group/Cohort | Intervention/treatment |
---|---|
001
Patients with Atrial Fibrillation (AF) Treatment patterns of AF according to patient demographics clinical factors risk stratification and geographic regions.
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Other: Patients with Atrial Fibrillation (AF)
Treatment patterns of AF according to patient demographics, clinical factors, risk stratification, and geographic regions. |
- The primary outcome is stroke or non-CNS (systemic) embolism. Key primary objective is: characterize & describe the AF patient population as a whole, with emphasis on demographics, comorbidities, and risk profiles. [ Time Frame: 3 years ]
- The number of major adverse cardiac events. [ Time Frame: 3 years ]

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Adult patients with incident (initial diagnosis) or prevalent (existing diagnosis) AF with electrocardiographic documentation
- anticipated ability to adhere to local regularly scheduled follow-up visits
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01165710

Study Director: | Janssen Scientific Affairs, LLC Clinical Trial | Janssen Scientific Affairs, LLC |
Responsible Party: | Janssen Scientific Affairs, LLC |
ClinicalTrials.gov Identifier: | NCT01165710 |
Other Study ID Numbers: |
CR016327 RIVAROXAFL4001 ( Other Identifier: Janssen Scientific Affairs, LLC ) |
First Posted: | July 20, 2010 Key Record Dates |
Last Update Posted: | January 24, 2017 |
Last Verified: | January 2017 |
Irregular heart beat |
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |