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

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

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

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
Intervention / Treatment
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

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

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

Janssen Scientific Affairs, LLC

Collaborators

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

June 1, 2010

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

July 16, 2010

First Submitted That Met QC Criteria

July 19, 2010

First Posted (Estimate)

July 20, 2010

Study Record Updates

Last Update Posted (Estimate)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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