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

January 23, 2017 updated by: Janssen Scientific Affairs, LLC
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10179

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Hato Rey, Puerto Rico
      • Rio Grande, Puerto Rico
      • San Juan, Puerto Rico
  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Dothan, Alabama, United States
      • Huntsville, Alabama, United States
      • Mobile, Alabama, United States
      • Montgomery, Alabama, United States
      • Pell City, Alabama, United States
      • Tuscaloosa, Alabama, United States
    • Arizona
      • Cottonwood, Arizona, United States
      • Tucson, Arizona, United States
    • Arkansas
      • Fort Smith, Arkansas, United States
    • California
      • Carlsbad, California, United States
      • Carmichael, California, United States
      • Corona, California, United States
      • Laguna Hills, California, United States
      • Long Beach, California, United States
      • Los Alamitos, California, United States
      • Los Angeles, California, United States
      • Montebello, California, United States
      • Northridge, California, United States
      • Orange, California, United States
      • Oxnard, California, United States
      • Palo Alto, California, United States
      • Pismo Beach, California, United States
      • Pomona, California, United States
      • San Diego, California, United States
      • San Ramon, California, United States
      • Santa Rosa, California, United States
      • Tarzana, California, United States
      • Torrance, California, United States
      • Tustin, California, United States
      • Ventura, California, United States
    • Colorado
      • Aurora, Colorado, United States
      • Colorado Springs, Colorado, United States
      • Golden, Colorado, United States
    • Delaware
      • Newark, Delaware, United States
      • Seaford, Delaware, United States
    • Florida
      • Boynton Beach, Florida, United States
      • Coral Springs, Florida, United States
      • Deerfield Beach, Florida, United States
      • Fort Myers, Florida, United States
      • Fort Walton Beach, Florida, United States
      • Hollywood, Florida, United States
      • Jupiter, Florida, United States
      • Lakeland, Florida, United States
      • Oakland Park, Florida, United States
      • Orange Park, Florida, United States
      • Ormond Beach, Florida, United States
      • Port Charlotte, Florida, United States
      • St. Petersburg, Florida, United States
      • Tallahassee, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Decatur, Georgia, United States
      • Marietta, Georgia, United States
      • Riverdale, Georgia, United States
    • Idaho
      • Idaho Falls, Idaho, United States
      • Nampa, Idaho, United States
    • Illinois
      • Aurora, Illinois, United States
      • Evergreen Park, Illinois, United States
      • Melrose Park, Illinois, United States
      • Peoria, Illinois, United States
      • Rock Island, Illinois, United States
      • Rockford, Illinois, United States
      • Urbana, Illinois, United States
      • Winfield, Illinois, United States
    • Indiana
      • Bloomington, Indiana, United States
      • Evansville, Indiana, United States
      • Hammond, Indiana, United States
      • Indianapolis, Indiana, United States
      • La Porte, Indiana, United States
      • South Bend, Indiana, United States
    • Iowa
      • Waterloo, Iowa, United States
    • Kansas
      • Overland Park, Kansas, United States
    • Kentucky
      • Crestview Hills, Kentucky, United States
      • Lexington, Kentucky, United States
      • Owensboro, Kentucky, United States
    • Louisiana
      • Alexandria, Louisiana, United States
    • Maine
      • Rockport, Maine, United States
    • Maryland
      • Beltsville, Maryland, United States
      • Salisbury, Maryland, United States
    • Massachusetts
      • Biddeford, Massachusetts, United States
    • Michigan
      • Bay City, Michigan, United States
      • Bridgman, Michigan, United States
      • Commerce Township, Michigan, United States
      • Grand Blanc, Michigan, United States
      • Lansing, Michigan, United States
      • Livonia, Michigan, United States
      • Mount Clemens, Michigan, United States
      • Stevensville, Michigan, United States
      • Traverse City, Michigan, United States
      • Troy, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • Montana
      • Anaconda, Montana, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • Bridgewater, New Jersey, United States
      • Elmer, New Jersey, United States
      • Haddon Heights, New Jersey, United States
      • Linden, New Jersey, United States
      • Nampa, New Jersey, United States
      • Ridgewood, New Jersey, United States
      • Sewell, New Jersey, United States
      • Toms River, New Jersey, United States
    • New York
      • Flushing, New York, United States
      • Huntington, New York, United States
      • Jamaica, New York, United States
      • New York, New York, United States
      • Northport, New York, United States
    • North Carolina
      • Calabash, North Carolina, United States
      • Charlotte, North Carolina, United States
      • Durham, North Carolina, United States
      • Greenwood, North Carolina, United States
      • Jacksonville, North Carolina, United States
      • Pinehurst, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Sanford, North Carolina, United States
      • Tabor City, North Carolina, United States
      • Winston Salem, North Carolina, United States
    • North Dakota
      • Fargo, North Dakota, United States
      • Minot, North Dakota, United States
    • Ohio
      • Mansfield, Ohio, United States
      • Miamisburg, Ohio, United States
      • Piqua, Ohio, United States
      • Toledo, Ohio, United States
      • Worthington, Ohio, United States
      • Youngstown, Ohio, United States
    • Pennsylvania
      • Abington, Pennsylvania, United States
      • Beaver, Pennsylvania, United States
      • Danville, Pennsylvania, United States
      • Doylestown, Pennsylvania, United States
      • Erie, Pennsylvania, United States
      • Lansdale, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Scranton, Pennsylvania, United States
      • Spring House, Pennsylvania, United States
      • West Reading, Pennsylvania, United States
      • Wynnewood, Pennsylvania, United States
      • Yardley, Pennsylvania, United States
    • Rhode Island
      • Pawtucket, Rhode Island, United States
    • South Carolina
      • Anderson, South Carolina, United States
      • Easley, South Carolina, United States
      • Spartanburg, South Carolina, United States
    • Tennessee
      • Harriman, Tennessee, United States
      • Kingsport, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Arlington, Texas, United States
      • Beaumont, Texas, United States
      • Corpus Christi, Texas, United States
      • Flower Mound, Texas, United States
      • Fort Worth, Texas, United States
      • Houston, Texas, United States
      • Mcallen, Texas, United States
      • Odessa, Texas, United States
      • Plano, Texas, United States
      • San Antonio, Texas, United States
      • Tomball, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Fredericksburg, Virginia, United States
      • Lynchburg, Virginia, United States
      • Midlothian, Virginia, United States
      • Roanoke, Virginia, United States
      • Winchester, Virginia, United States
    • Washington
      • Burien, Washington, United States
      • Port Orchard, Washington, United States
      • Spokane, Washington, United States
      • Tacoma, Washington, United States
      • Vancouver, Washington, United States
    • Wisconsin
      • La Crosse, Wisconsin, United States
      • Madison, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
001
Patients with Atrial Fibrillation (AF) Treatment patterns of AF according to patient demographics clinical factors risk stratification and geographic regions.
Other: Patients with Atrial Fibrillation (AF)
Treatment patterns of AF according to patient demographics, clinical factors, risk stratification, and geographic regions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The number of major adverse cardiac events.
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Scientific Affairs, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bayer
Duke Clinical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR016327
  • RIVAROXAFL4001 (Other Identifier: Janssen Scientific Affairs, LLC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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