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

January 31, 2025 updated by: Janssen Scientific Affairs, LLC

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

The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF II) is a multicenter, prospective outpatient disease registry to evaluate the utilization of target-specific antithrombotic agents, such as FXa (factor Xa) inhibitors and direct thrombin inhibitors, and associated outcomes. Importantly, the ORBIT AF II registry will permit the collection and analysis of post-approval observational data needed for evaluating the outcomes associated with these new agents when used in broader patient populations outside of clinical 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. Taken together, the ORBIT-AF I and ORBIT-AF II registries will offer a broad and contemporary view of AF therapy.

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 registry will be used to evaluate, describe, and document the safety of target-specific anticoagulant agents (and other antithrombotic agents) in patients with Atrial Fibrillation (AF), the clinical outcomes associated with their use, the treatment patterns and clinical course of patients with AF, including those who undergo cardiac procedures of interest (ablation, cardioversion, catheterization and surgery, for examples), and characteristics of patients with new onset/first-detected AF. Additionally, the registry will be used to summarize patterns of switching or discontinuation of antithrombotic agents in the United States. The registry will be a nationwide collaboration of health care providers (eg, cardiologists, internists, primary care physicians, electrophysiologists, quality improvement personnel, office/practice managers, research coordinators, and pharmacists). Target enrollment will be approximately 15,000 patients. It is anticipated that enrollment will complete in approximately 3.5 years. 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 up to 2 years. New patients enrolled in the registry will be followed for up to 1 year. Patient follow-up by their AF care provider will continue as scheduled according to local clinical practice. Data collection will occur at 6 month intervals for approximately 1 year from the time of enrollment of the patient (baseline, 6, and 12 months). Data capture will include demographics, medical history, cardiovascular history, vital signs, echocardiographic and laboratory data, AF status and type (paroxysmal, persistent, long-standing persistent/permanent), pharmacotherapy, contraindications to oral anticoagulant therapy, and provider specialty. Clinical outcomes and safety data capture will include major adverse cardiac events (MACEs).

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.
13769

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
      • Rio Grande, Puerto Rico
  • United States
    • Alabama
      • Cullman, Alabama, United States
      • Dothan, Alabama, United States
      • Fairhope, Alabama, United States
      • Mobile, Alabama, United States
      • Tuscaloosa, Alabama, United States
    • Arizona
      • Avondale, Arizona, United States
      • Glendale, Arizona, United States
      • Goodyear, Arizona, United States
      • Scottsdale, Arizona, United States
      • Sun City, Arizona, United States
      • Tucson, Arizona, United States
    • California
      • Alhambra, California, United States
      • Anaheim, California, United States
      • Bakersfield, California, United States
      • Banning, California, United States
      • Beverly Hills, California, United States
      • Carlsbad, California, United States
      • Concord, California, United States
      • East Palo Alto, California, United States
      • Fresno, California, United States
      • Huntington Beach, California, United States
      • Laguna Hills, California, United States
      • Larkspur, California, United States
      • Long Beach, California, United States
      • Los Alamitos, California, United States
      • Los Angeles, California, United States
      • Manhattan Beach, California, United States
      • Mission Hills, California, United States
      • Newport Beach, California, United States
      • Northridge, California, United States
      • Pasadena, California, United States
      • Pismo Beach, California, United States
      • Pomona, California, United States
      • Poway, California, United States
      • Rancho Mirage, California, United States
      • San Pedro, California, United States
      • Santa Rosa, California, United States
      • Torrance, California, United States
      • Ventura, California, United States
    • Colorado
      • Aurora, Colorado, United States
      • Colorado Springs, Colorado, United States
      • Lakewood, Colorado, United States
    • Connecticut
      • Bridgeport, Connecticut, United States
      • Guilford, Connecticut, United States
    • Delaware
      • Laurel, Delaware, United States
      • Newark, Delaware, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Bay Pines, Florida, United States
      • Clearwater, Florida, United States
      • Coral Springs, Florida, United States
      • Eustis, Florida, United States
      • Jupiter, Florida, United States
      • Lakeland, Florida, United States
      • Miami, Florida, United States
      • Miramar, Florida, United States
      • Palm Harbor, Florida, United States
      • Pensacola, Florida, United States
      • Port Charlotte, Florida, United States
      • Tampa, Florida, United States
      • Wellington, Florida, United States
    • Georgia
      • Alpharetta, Georgia, United States
      • Athens, Georgia, United States
      • Atlanta, Georgia, United States
      • Cumming, Georgia, United States
      • Gainesville, Georgia, United States
      • Macon, Georgia, United States
      • Marietta, Georgia, United States
      • Rome, Georgia, United States
      • Smyrna, Georgia, United States
    • Idaho
      • Idaho Falls, Idaho, United States
      • Pocatello, Idaho, United States
    • Illinois
      • Aurora, Illinois, United States
      • Hines, Illinois, United States
      • Melrose Park, Illinois, United States
      • New Lenox, Illinois, United States
      • North Chicago, Illinois, United States
      • Peoria, Illinois, United States
      • Rock Island, Illinois, United States
    • Indiana
      • Anderson, Indiana, United States
      • Bloomington, Indiana, United States
      • Hammond, Indiana, United States
      • Indianapolis, Indiana, United States
      • La Porte, Indiana, United States
      • Munster, Indiana, United States
      • South Bend, Indiana, United States
    • Iowa
      • Davenport, Iowa, United States
      • Waterloo, Iowa, United States
    • Kansas
      • Overland Park, Kansas, United States
    • Kentucky
      • Elizabethtown, Kentucky, United States
      • Louisville, Kentucky, United States
      • Mount Sterling, Kentucky, United States
    • Louisiana
      • Alexandria, Louisiana, United States
      • Bossier City, Louisiana, United States
      • Natchitoches, Louisiana, United States
      • New Orleans, Louisiana, United States
      • Shreveport, Louisiana, United States
    • Maine
      • Rockport, Maine, United States
    • Maryland
      • Annapolis, Maryland, United States
      • Baltimore, Maryland, United States
      • Randallstown, Maryland, United States
      • Salisbury, Maryland, United States
    • Massachusetts
      • Fall River, Massachusetts, United States
    • Michigan
      • Alpena, Michigan, United States
      • Bay City, Michigan, United States
      • Flint, Michigan, United States
      • Grand Blanc, Michigan, United States
      • Lansing, Michigan, United States
      • Lapeer, Michigan, United States
      • Mount Clemens, Michigan, United States
      • Rochester Hills, Michigan, United States
      • Saint Joseph, Michigan, United States
      • Traverse City, Michigan, United States
      • Troy, Michigan, United States
      • Ypsilanti, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • Missouri
      • Bridgeton, Missouri, United States
      • Kansas City, Missouri, United States
    • Nebraska
      • Fremont, Nebraska, United States
    • Nevada
      • Las Vegas, Nevada, United States
      • Reno, Nevada, United States
    • New Hampshire
      • Nashua, New Hampshire, United States
    • New Jersey
      • Bridgewater, New Jersey, United States
      • East Brunswick, New Jersey, United States
      • Flemington, New Jersey, United States
      • Linden, New Jersey, United States
      • Manalapan, New Jersey, United States
      • Moorestown, New Jersey, United States
      • Mountain Lakes, New Jersey, United States
      • Somerset, New Jersey, United States
      • Toms River, New Jersey, United States
      • Voorhees, New Jersey, United States
      • Wayne, New Jersey, United States
    • New York
      • Albany, New York, United States
      • Flushing, New York, United States
      • Huntington, New York, United States
      • Jackson Heights, New York, United States
      • Jamaica, New York, United States
      • Jamestown, New York, United States
      • Lake Success, New York, United States
      • Mineola, New York, United States
      • Mount Kisco, New York, United States
      • New York, New York, United States
      • North Massapequa, New York, United States
      • Utica, New York, United States
    • North Carolina
      • Burlington, North Carolina, United States
      • Chapel Hill, North Carolina, United States
      • Durham, North Carolina, United States
      • Elizabeth City, North Carolina, United States
      • Greensboro, North Carolina, United States
      • Pinehurst, North Carolina, United States
      • Sanford, North Carolina, United States
      • Spartanburg, North Carolina, United States
    • Ohio
      • Canton, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
      • Mansfield, Ohio, United States
      • Miamisburg, Ohio, United States
      • Toledo, Ohio, United States
      • Worthington, Ohio, United States
      • Youngstown, Ohio, United States
    • Oklahoma
      • Tulsa, Oklahoma, United States
    • Oregon
      • Medford, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Abington, Pennsylvania, United States
      • Chambersburg, Pennsylvania, United States
      • Doylestown, Pennsylvania, United States
      • Ephrata, Pennsylvania, United States
      • Langhorne, Pennsylvania, United States
      • Lansdale, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Sayre, Pennsylvania, United States
      • West Reading, Pennsylvania, United States
      • Wynnewood, Pennsylvania, United States
      • Yardley, Pennsylvania, United States
    • Rhode Island
      • Providence, Rhode Island, United States
      • Warwick, Rhode Island, United States
      • Woonsocket, Rhode Island, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • Easley, South Carolina, United States
      • Lancaster, South Carolina, United States
    • Tennessee
      • Bristol, Tennessee, United States
      • Jackson, Tennessee, United States
      • Kingsport, Tennessee, United States
      • Memphis, Tennessee, United States
      • Nashville, Tennessee, United States
      • Oak Ridge, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Beaumont, Texas, United States
      • Corpus Christi, Texas, United States
      • Dallas, Texas, United States
      • Fort Sam Houston, Texas, United States
      • Fort Worth, Texas, United States
      • Houston, Texas, United States
      • Katy, Texas, United States
      • McKinney, Texas, United States
      • Odessa, Texas, United States
      • Palestine, Texas, United States
      • Plano, Texas, United States
      • Round Rock, Texas, United States
      • San Antonio, Texas, United States
      • Tomball, Texas, United States
      • Tyler, Texas, United States
    • Virginia
      • Annandale, Virginia, United States
      • Lynchburg, Virginia, United States
      • Mechanicsville, Virginia, United States
      • Midlothian, Virginia, United States
      • Newport News, Virginia, United States
      • Virginia Beach, Virginia, United States
    • Washington
      • Seattle, Washington, United States
      • Tacoma, Washington, United States
      • Vancouver, Washington, United States
      • Walla Walla, Washington, United States
    • West Virginia
      • Charleston, West Virginia, United States
    • Wisconsin
      • La Crosse, Wisconsin, United States
      • Milwaukee, Wisconsin, United States
      • Waukesha, Wisconsin, United States
      • Wausau, Wisconsin, United States
  • Virgin Islands (U.S.)
      • Saint Thomas, Virgin Islands (U.S.)

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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) AF (Atrial Fibrillation) with electrocardiographic documentation or patients with prevalent (existing diagnosis) AF who had initiation or transition to a 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

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

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.
Patients with Atrial Fibrillation (AF)
(1) patients with new onset/first detected Atrial Fibrillation (AF) diagnosed within the 6 months preceding the baseline visit; or (2) patients with AF who had initiation or transition to a FXa (Factor Xa) inhibitor or a direct thrombin inhibitor within the preceding 3 months.
Other: Patients with Atrial Fibrillation
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
Measure Description
Time Frame
Number of major bleeding events
Time Frame: 2 years
Major bleeding will be defined according to International Society of Thrombosis and Hemostasis (ISTH) criteria.
2 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
Measure Description
Time Frame
Number of major adverse cardiac events
Time Frame: 2 years
Major cardiac events are defined as stroke or non-central nervous system (non-CNS) systemic embolism, myocardial infarction, and cardiovascular death.
2 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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Scientific Affairs, LLC Clinical Trial, Janssen Scientific Affairs, LLC

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 (Actual)

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.
February 20, 2013

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.
July 12, 2017

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.
July 12, 2017

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).
October 3, 2012

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.
October 4, 2012

First Posted (Estimated)

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.
October 5, 2012

Study Record Updates

Last Update Posted (Actual)

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.
March 25, 2025

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 31, 2025

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, 2025

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.
  • CR100871
  • RIVAROXAFL4002 (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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