Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF)
2 other identifiers
observational
10,179
2 countries
171
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2010
Longer than P75 for all trials
171 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 16, 2010
CompletedFirst Posted
Study publicly available on registry
July 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJanuary 24, 2017
January 1, 2017
4.4 years
July 16, 2010
January 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 years
Secondary Outcomes (1)
The number of major adverse cardiac events.
3 years
Study Arms (1)
001
Patients with Atrial Fibrillation (AF) Treatment patterns of AF according to patient demographics clinical factors risk stratification and geographic regions.
Interventions
Treatment patterns of AF according to patient demographics, clinical factors, risk stratification, and geographic regions.
Eligibility Criteria
Enrolling physicians will include cardiologists, internists, and electrophysiologists from both academic and private practice who preferably have experience in registry participation.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen Scientific Affairs, LLClead
- Duke Clinical Research Institutecollaborator
- Bayercollaborator
Study Sites (171)
Unknown Facility
Birmingham, Alabama, United States
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Dothan, Alabama, United States
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Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Montgomery, Alabama, United States
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Pell City, Alabama, United States
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Tuscaloosa, Alabama, United States
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Cottonwood, Arizona, United States
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Tucson, Arizona, United States
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Fort Smith, Arkansas, United States
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Carlsbad, California, United States
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Carmichael, California, United States
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Corona, California, United States
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Laguna Hills, California, United States
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Long Beach, California, United States
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Los Alamitos, California, United States
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Los Angeles, California, United States
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Montebello, California, United States
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Northridge, California, United States
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Orange, California, United States
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Oxnard, California, United States
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Palo Alto, California, United States
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Pismo Beach, California, United States
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Pomona, California, United States
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San Diego, California, United States
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San Ramon, California, United States
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Santa Rosa, California, United States
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Tarzana, California, United States
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Torrance, California, United States
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Tustin, California, United States
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Ventura, California, United States
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Aurora, Colorado, United States
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Colorado Springs, Colorado, United States
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Golden, Colorado, United States
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Newark, Delaware, United States
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Seaford, Delaware, United States
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Boynton Beach, Florida, United States
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Coral Springs, Florida, United States
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Deerfield Beach, Florida, United States
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Fort Myers, Florida, United States
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Fort Walton Beach, Florida, United States
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Hollywood, Florida, United States
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Jupiter, Florida, United States
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Lakeland, Florida, United States
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Oakland Park, Florida, United States
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Orange Park, Florida, United States
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Ormond Beach, Florida, United States
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Port Charlotte, Florida, United States
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St. Petersburg, Florida, United States
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Tallahassee, Florida, United States
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Marietta, Georgia, United States
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Riverdale, Georgia, United States
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Idaho Falls, Idaho, United States
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Nampa, Idaho, United States
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Aurora, Illinois, United States
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Evergreen Park, Illinois, United States
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Melrose Park, Illinois, United States
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Peoria, Illinois, United States
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Rock Island, Illinois, United States
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Rockford, Illinois, United States
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Urbana, Illinois, United States
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Winfield, Illinois, United States
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Bloomington, Indiana, United States
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Evansville, Indiana, United States
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Hammond, Indiana, United States
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Indianapolis, Indiana, United States
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La Porte, Indiana, United States
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South Bend, Indiana, United States
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Waterloo, Iowa, United States
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Overland Park, Kansas, United States
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Crestview Hills, Kentucky, United States
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Lexington, Kentucky, United States
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Owensboro, Kentucky, United States
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Alexandria, Louisiana, United States
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Rockport, Maine, United States
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Beltsville, Maryland, United States
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Salisbury, Maryland, United States
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Biddeford, Massachusetts, United States
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Bay City, Michigan, United States
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Bridgman, Michigan, United States
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Commerce, Michigan, United States
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Grand Blanc, Michigan, United States
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Lansing, Michigan, United States
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Livonia, Michigan, United States
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Mount Clemens, Michigan, United States
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Stevensville, Michigan, United States
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Traverse City, Michigan, United States
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Troy, Michigan, United States
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Minneapolis, Minnesota, United States
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Anaconda, Montana, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Bridgewater, New Jersey, United States
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Elmer, New Jersey, United States
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Haddon Heights, New Jersey, United States
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Linden, New Jersey, United States
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Nampa, New Jersey, United States
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Ridgewood, New Jersey, United States
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Sewell, New Jersey, United States
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Toms River, New Jersey, United States
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Flushing, New York, United States
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Huntington, New York, United States
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Jamaica, New York, United States
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New York, New York, United States
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Northport, New York, United States
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Calabash, North Carolina, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Greenwood, North Carolina, United States
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Jacksonville, North Carolina, United States
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Pinehurst, North Carolina, United States
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Raleigh, North Carolina, United States
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Sanford, North Carolina, United States
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Tabor City, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Fargo, North Dakota, United States
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Minot, North Dakota, United States
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Mansfield, Ohio, United States
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Miamisburg, Ohio, United States
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Piqua, Ohio, United States
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Toledo, Ohio, United States
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Worthington, Ohio, United States
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Youngstown, Ohio, United States
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Abington, Pennsylvania, United States
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Beaver, Pennsylvania, United States
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Danville, Pennsylvania, United States
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Doylestown, Pennsylvania, United States
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Erie, Pennsylvania, United States
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Lansdale, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Scranton, Pennsylvania, United States
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Spring House, Pennsylvania, United States
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West Reading, Pennsylvania, United States
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Wynnewood, Pennsylvania, United States
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Yardley, Pennsylvania, United States
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Pawtucket, Rhode Island, United States
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Anderson, South Carolina, United States
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Easley, South Carolina, United States
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Spartanburg, South Carolina, United States
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Harriman, Tennessee, United States
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Kingsport, Tennessee, United States
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Nashville, Tennessee, United States
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Arlington, Texas, United States
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Beaumont, Texas, United States
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Corpus Christi, Texas, United States
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Flower Mound, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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McAllen, Texas, United States
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Odessa, Texas, United States
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Plano, Texas, United States
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San Antonio, Texas, United States
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Tomball, Texas, United States
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Salt Lake City, Utah, United States
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Fredericksburg, Virginia, United States
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Lynchburg, Virginia, United States
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Midlothian, Virginia, United States
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Roanoke, Virginia, United States
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Winchester, Virginia, United States
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Burien, Washington, United States
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Port Orchard, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Vancouver, Washington, United States
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La Crosse, Wisconsin, United States
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Madison, Wisconsin, United States
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Hato Rey, Puerto Rico
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Río Grande, Puerto Rico
Unknown Facility
San Juan, Puerto Rico
Related Publications (19)
Fox KAA, Virdone S, Pieper KS, Bassand JP, Camm AJ, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Kayani G, Oto A, Misselwitz F, Piccini JP, Dalgaard F, Turpie AGG, Verheugt FWA, Kakkar AK; GARFIELD-AF Investigators. GARFIELD-AF risk score for mortality, stroke, and bleeding within 2 years in patients with atrial fibrillation. Eur Heart J Qual Care Clin Outcomes. 2022 Mar 2;8(2):214-227. doi: 10.1093/ehjqcco/qcab028.
PMID: 33892489DERIVEDSteinberg BA, Holmes DN, Pieper K, Allen LA, Chan PS, Ezekowitz MD, Freeman JV, Fonarow GC, Gersh BJ, Hylek EM, Kowey PR, Mahaffey KW, Naccarelli G, Reiffel J, Singer DE, Peterson ED, Piccini JP; ORBIT-AF (Outcomes Registry for Better Informed Treatment of Atrial Fibrillation) Investigators and Patients. Factors Associated With Large Improvements in Health-Related Quality of Life in Patients With Atrial Fibrillation: Results From ORBIT-AF. Circ Arrhythm Electrophysiol. 2020 May;13(5):e007775. doi: 10.1161/CIRCEP.119.007775. Epub 2020 Apr 16.
PMID: 32298144DERIVEDHolmes DN, Piccini JP, Allen LA, Fonarow GC, Gersh BJ, Kowey PR, O'Brien EC, Reiffel JA, Naccarelli GV, Ezekowitz MD, Chan PS, Singer DE, Spertus JA, Peterson ED, Thomas L. Defining Clinically Important Difference in the Atrial Fibrillation Effect on Quality-of-Life Score. Circ Cardiovasc Qual Outcomes. 2019 May;12(5):e005358. doi: 10.1161/CIRCOUTCOMES.118.005358.
PMID: 31092022DERIVEDThind M, Holmes DN, Badri M, Pieper KS, Singh A, Blanco RG, Steinberg BA, Fonarow GC, Gersh BJ, Mahaffey KW, Peterson ED, Reiffel JA, Piccini JP, Kowey PR; ORBIT-AF Investigators and Patients. Embolic and Other Adverse Outcomes in Symptomatic Versus Asymptomatic Patients With Atrial Fibrillation (from the ORBIT-AF Registry). Am J Cardiol. 2018 Nov 15;122(10):1677-1683. doi: 10.1016/j.amjcard.2018.07.045. Epub 2018 Aug 20.
PMID: 30227964DERIVEDDurheim MT, Holmes DN, Blanco RG, Allen LA, Chan PS, Freeman JV, Fonarow GC, Go AS, Hylek EM, Mahaffey KW, Pokorney SD, Reiffel JA, Singer DE, Peterson ED, Piccini JP. Characteristics and outcomes of adults with chronic obstructive pulmonary disease and atrial fibrillation. Heart. 2018 Nov;104(22):1850-1858. doi: 10.1136/heartjnl-2017-312735. Epub 2018 Jun 6.
PMID: 29875139DERIVEDO'Brien EC, Holmes DN, Thomas LE, Fonarow GC, Allen LA, Gersh BJ, Kowey PR, Singer DE, Ezekowitz MD, Naccarelli GV, Ansell JE, Chan PS, Mahaffey KW, Go AS, Freeman JV, Reiffel JA, Peterson ED, Piccini JP, Hylek EM. Prognostic Significance of Nuisance Bleeding in Anticoagulated Patients With Atrial Fibrillation. Circulation. 2018 Aug 28;138(9):889-897. doi: 10.1161/CIRCULATIONAHA.117.031354.
PMID: 29678813DERIVEDFox KAA, Lucas JE, Pieper KS, Bassand JP, Camm AJ, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Hacke W, Kayani G, Oto A, Mantovani LG, Misselwitz F, Piccini JP, Turpie AGG, Verheugt FWA, Kakkar AK; GARFIELD-AF Investigators. Improved risk stratification of patients with atrial fibrillation: an integrated GARFIELD-AF tool for the prediction of mortality, stroke and bleed in patients with and without anticoagulation. BMJ Open. 2017 Dec 21;7(12):e017157. doi: 10.1136/bmjopen-2017-017157.
PMID: 29273652DERIVEDPiccini JP, Simon DN, Steinberg BA, Thomas L, Allen LA, Fonarow GC, Gersh B, Hylek E, Kowey PR, Reiffel JA, Naccarelli GV, Chan PS, Spertus JA, Peterson ED; Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) Investigators and Patients. Differences in Clinical and Functional Outcomes of Atrial Fibrillation in Women and Men: Two-Year Results From the ORBIT-AF Registry. JAMA Cardiol. 2016 Jun 1;1(3):282-91. doi: 10.1001/jamacardio.2016.0529.
PMID: 27438106DERIVEDGolwala H, Jackson LR 2nd, Simon DN, Piccini JP, Gersh B, Go AS, Hylek EM, Kowey PR, Mahaffey KW, Thomas L, Fonarow GC, Peterson ED, Thomas KL; Outcomes Registry for Better Informed Treatment for Atrial Fibrillation (ORBIT-AF) Registry. Racial/ethnic differences in atrial fibrillation symptoms, treatment patterns, and outcomes: Insights from Outcomes Registry for Better Informed Treatment for Atrial Fibrillation Registry. Am Heart J. 2016 Apr;174:29-36. doi: 10.1016/j.ahj.2015.10.028. Epub 2015 Dec 30.
PMID: 26995367DERIVEDJackson LR 2nd, Kim SH, Piccini JP Sr, Gersh BJ, Naccarelli GV, Reiffel JA, Freeman J, Thomas L, Chang P, Fonarow GC, Go AS, Mahaffey KW, Peterson ED, Kowey PR. Sinus Node Dysfunction Is Associated With Higher Symptom Burden and Increased Comorbid Illness: Results From the ORBIT-AF Registry. Clin Cardiol. 2016 Feb;39(2):119-25. doi: 10.1002/clc.22504. Epub 2015 Dec 31.
PMID: 26720750DERIVEDSteinberg BA, Kim S, Thomas L, Fonarow GC, Gersh BJ, Holmqvist F, Hylek E, Kowey PR, Mahaffey KW, Naccarelli G, Reiffel JA, Chang P, Peterson ED, Piccini JP; Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) Investigators and Patients. Increased Heart Rate Is Associated With Higher Mortality in Patients With Atrial Fibrillation (AF): Results From the Outcomes Registry for Better Informed Treatment of AF (ORBIT-AF). J Am Heart Assoc. 2015 Sep 14;4(9):e002031. doi: 10.1161/JAHA.115.002031.
PMID: 26370445DERIVEDHolmqvist F, Simon D, Steinberg BA, Hong SJ, Kowey PR, Reiffel JA, Naccarelli GV, Chang P, Gersh BJ, Peterson ED, Piccini JP; ORBIT-AF Investigators. Catheter Ablation of Atrial Fibrillation in U.S. Community Practice--Results From Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). J Am Heart Assoc. 2015 May 21;4(5):e001901. doi: 10.1161/JAHA.115.001901.
PMID: 25999401DERIVEDHolmqvist F, Guan N, Zhu Z, Kowey PR, Allen LA, Fonarow GC, Hylek EM, Mahaffey KW, Freeman JV, Chang P, Holmes DN, Peterson ED, Piccini JP, Gersh BJ; ORBIT-AF Investigators. Impact of obstructive sleep apnea and continuous positive airway pressure therapy on outcomes in patients with atrial fibrillation-Results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). Am Heart J. 2015 May;169(5):647-654.e2. doi: 10.1016/j.ahj.2014.12.024. Epub 2015 Feb 7.
PMID: 25965712DERIVEDSteinberg BA, Peterson ED, Kim S, Thomas L, Gersh BJ, Fonarow GC, Kowey PR, Mahaffey KW, Sherwood MW, Chang P, Piccini JP, Ansell J; Outcomes Registry for Better Informed Treatment of Atrial Fibrillation Investigators and Patients. Use and outcomes associated with bridging during anticoagulation interruptions in patients with atrial fibrillation: findings from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). Circulation. 2015 Feb 3;131(5):488-94. doi: 10.1161/CIRCULATIONAHA.114.011777. Epub 2014 Dec 12.
PMID: 25499873DERIVEDSteinberg BA, Kim S, Fonarow GC, Thomas L, Ansell J, Kowey PR, Mahaffey KW, Gersh BJ, Hylek E, Naccarelli G, Go AS, Reiffel J, Chang P, Peterson ED, Piccini JP. Drivers of hospitalization for patients with atrial fibrillation: Results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). Am Heart J. 2014 May;167(5):735-42.e2. doi: 10.1016/j.ahj.2014.02.003. Epub 2014 Feb 17.
PMID: 24766985DERIVEDSteinberg BA, Kim S, Thomas L, Fonarow GC, Hylek E, Ansell J, Go AS, Chang P, Kowey P, Gersh BJ, Mahaffey KW, Singer DE, Piccini JP, Peterson ED; Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) Investigators and Patients. Lack of concordance between empirical scores and physician assessments of stroke and bleeding risk in atrial fibrillation: results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) registry. Circulation. 2014 May 20;129(20):2005-12. doi: 10.1161/CIRCULATIONAHA.114.008643. Epub 2014 Mar 29.
PMID: 24682387DERIVEDSteinberg BA, Holmes DN, Piccini JP, Ansell J, Chang P, Fonarow GC, Gersh B, Mahaffey KW, Kowey PR, Ezekowitz MD, Singer DE, Thomas L, Peterson ED, Hylek EM; Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) Investigators and Patients. Early adoption of dabigatran and its dosing in US patients with atrial fibrillation: results from the outcomes registry for better informed treatment of atrial fibrillation. J Am Heart Assoc. 2013 Nov 25;2(6):e000535. doi: 10.1161/JAHA.113.000535.
PMID: 24275632DERIVEDSteinberg BA, Kim S, Piccini JP, Fonarow GC, Lopes RD, Thomas L, Ezekowitz MD, Ansell J, Kowey P, Singer DE, Gersh B, Mahaffey KW, Hylek E, Go AS, Chang P, Peterson ED; ORBIT-AF Investigators and Patients. Use and associated risks of concomitant aspirin therapy with oral anticoagulation in patients with atrial fibrillation: insights from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) Registry. Circulation. 2013 Aug 13;128(7):721-8. doi: 10.1161/CIRCULATIONAHA.113.002927. Epub 2013 Jul 16.
PMID: 23861512DERIVEDPiccini JP, Fraulo ES, Ansell JE, Fonarow GC, Gersh BJ, Go AS, Hylek EM, Kowey PR, Mahaffey KW, Thomas LE, Kong MH, Lopes RD, Mills RM, Peterson ED. Outcomes registry for better informed treatment of atrial fibrillation: rationale and design of ORBIT-AF. Am Heart J. 2011 Oct;162(4):606-612.e1. doi: 10.1016/j.ahj.2011.07.001.
PMID: 21982650DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Scientific Affairs, LLC Clinical Trial
Janssen Scientific Affairs, LLC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2010
First Posted
July 20, 2010
Study Start
June 1, 2010
Primary Completion
November 1, 2014
Study Completion
December 1, 2014
Last Updated
January 24, 2017
Record last verified: 2017-01