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Atrial FibrillationNCT01165710

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

An observational study of Atrial Fibrillation, run by Janssen Scientific Affairs, LLC at 171 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Atrial Fibrillation
What is being tested?
Patients with Atrial Fibrillation (AF)
How many people
10,179 participants
Where
171 sitesin 2 countries
Study dates
Jun 2010to Dec 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Enrolling physicians will include cardiologists, internists, and electrophysiologists from both academic and private practice who preferably have experience in registry participation.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

171 sites in 2 countries.

171 sites in 2 countries

United States168 sites

  • Study site

    Abington, Pennsylvania

  • Study site

    Alexandria, Louisiana

  • Study site

    Anaconda, Montana

  • Study site

    Anderson, South Carolina

  • Study site

    Arlington, Texas

  • Study site

    Atlanta, Georgia

  • Study site

    Aurora, Colorado

  • Study site

    Aurora, Illinois

  • Study site

    Bay City, Michigan

  • Study site

    Beaumont, Texas

  • Study site

    Beaver, Pennsylvania

  • Study site

    Beltsville, Maryland

  • Study site

    Biddeford, Massachusetts

  • Study site

    Birmingham, Alabama

  • Study site

    Bloomington, Indiana

  • Study site

    Boynton Beach, Florida

  • Study site

    Bridgewater, New Jersey

  • Study site

    Bridgman, Michigan

  • Study site

    Burien, Washington

  • Study site

    Calabash, North Carolina

  • Study site

    Carlsbad, California

  • Study site

    Carmichael, California

  • Study site

    Charlotte, North Carolina

  • Study site

    Colorado Springs, Colorado

  • Study site

    Commerce, Michigan

  • Study site

    Coral Springs, Florida

  • Study site

    Corona, California

  • Study site

    Corpus Christi, Texas

  • Study site

    Cottonwood, Arizona

  • Study site

    Crestview Hills, Kentucky

  • Study site

    Danville, Pennsylvania

  • Study site

    Decatur, Georgia

  • Study site

    Deerfield Beach, Florida

  • Study site

    Dothan, Alabama

  • Study site

    Doylestown, Pennsylvania

  • Study site

    Durham, North Carolina

  • Study site

    Easley, South Carolina

  • Study site

    Elmer, New Jersey

  • Study site

    Erie, Pennsylvania

  • Study site

    Evansville, Indiana

  • Study site

    Evergreen Park, Illinois

  • Study site

    Fargo, North Dakota

  • Study site

    Flower Mound, Texas

  • Study site

    Flushing, New York

  • Study site

    Fort Myers, Florida

  • Study site

    Fort Smith, Arkansas

  • Study site

    Fort Walton Beach, Florida

  • Study site

    Fort Worth, Texas

  • Study site

    Fredericksburg, Virginia

  • Study site

    Golden, Colorado

  • Study site

    Grand Blanc, Michigan

  • Study site

    Greenwood, North Carolina

  • Study site

    Haddon Heights, New Jersey

  • Study site

    Hammond, Indiana

  • Study site

    Harriman, Tennessee

  • Study site

    Hollywood, Florida

  • Study site

    Houston, Texas

  • Study site

    Huntington, New York

  • Study site

    Huntsville, Alabama

  • Study site

    Idaho Falls, Idaho

  • Study site

    Indianapolis, Indiana

  • Study site

    Jacksonville, North Carolina

  • Study site

    Jamaica, New York

  • Study site

    Jupiter, Florida

  • Study site

    Kingsport, Tennessee

  • Study site

    La Crosse, Wisconsin

  • Study site

    La Porte, Indiana

  • Study site

    Laguna Hills, California

  • Study site

    Lakeland, Florida

  • Study site

    Lansdale, Pennsylvania

  • Study site

    Lansing, Michigan

  • Study site

    Las Vegas, Nevada

  • Study site

    Lexington, Kentucky

  • Study site

    Linden, New Jersey

  • Study site

    Livonia, Michigan

  • Study site

    Long Beach, California

  • Study site

    Los Alamitos, California

  • Study site

    Los Angeles, California

  • Study site

    Lynchburg, Virginia

  • Study site

    Madison, Wisconsin

  • Study site

    Mansfield, Ohio

  • Study site

    Marietta, Georgia

  • Study site

    McAllen, Texas

  • Study site

    Melrose Park, Illinois

  • Study site

    Miamisburg, Ohio

  • Study site

    Midlothian, Virginia

  • Study site

    Minneapolis, Minnesota

  • Study site

    Minot, North Dakota

  • Study site

    Mobile, Alabama

  • Study site

    Montebello, California

  • Study site

    Montgomery, Alabama

  • Study site

    Mount Clemens, Michigan

  • Study site

    Nampa, Idaho

  • Study site

    Nampa, New Jersey

  • Study site

    Nashville, Tennessee

  • Study site

    New York, New York

  • Study site

    Newark, Delaware

  • Study site

    Northport, New York

  • Study site

    Northridge, California

  • Study site

    Oakland Park, Florida

  • Study site

    Odessa, Texas

  • Study site

    Omaha, Nebraska

  • Study site

    Orange, California

  • Study site

    Orange Park, Florida

  • Study site

    Ormond Beach, Florida

  • Study site

    Overland Park, Kansas

  • Study site

    Owensboro, Kentucky

  • Study site

    Oxnard, California

  • Study site

    Palo Alto, California

  • Study site

    Pawtucket, Rhode Island

  • Study site

    Pell City, Alabama

  • Study site

    Peoria, Illinois

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pinehurst, North Carolina

  • Study site

    Piqua, Ohio

  • Study site

    Pismo Beach, California

  • Study site

    Plano, Texas

  • Study site

    Pomona, California

  • Study site

    Port Charlotte, Florida

  • Study site

    Port Orchard, Washington

  • Study site

    Raleigh, North Carolina

  • Study site

    Ridgewood, New Jersey

  • Study site

    Riverdale, Georgia

  • Study site

    Roanoke, Virginia

  • Study site

    Rock Island, Illinois

  • Study site

    Rockford, Illinois

  • Study site

    Rockport, Maine

  • Study site

    Salisbury, Maryland

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    San Ramon, California

  • Study site

    Sanford, North Carolina

  • Study site

    Santa Rosa, California

  • Study site

    Scranton, Pennsylvania

  • Study site

    Seaford, Delaware

  • Study site

    Sewell, New Jersey

  • Study site

    South Bend, Indiana

  • Study site

    Spartanburg, South Carolina

  • Study site

    Spokane, Washington

  • Study site

    Spring House, Pennsylvania

  • Study site

    St. Petersburg, Florida

  • Study site

    Stevensville, Michigan

  • Study site

    Tabor City, North Carolina

  • Study site

    Tacoma, Washington

  • Study site

    Tallahassee, Florida

  • Study site

    Tarzana, California

  • Study site

    Toledo, Ohio

  • Study site

    Tomball, Texas

  • Study site

    Toms River, New Jersey

  • Study site

    Torrance, California

  • Study site

    Traverse City, Michigan

  • Study site

    Troy, Michigan

  • Study site

    Tucson, Arizona

  • Study site

    Tuscaloosa, Alabama

  • Study site

    Tustin, California

  • Study site

    Urbana, Illinois

  • Study site

    Vancouver, Washington

  • Study site

    Ventura, California

  • Study site

    Waterloo, Iowa

  • Study site

    West Reading, Pennsylvania

  • Study site

    Winchester, Virginia

  • Study site

    Winfield, Illinois

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Worthington, Ohio

  • Study site

    Wynnewood, Pennsylvania

  • Study site

    Yardley, Pennsylvania

  • Study site

    Youngstown, Ohio

Other trials in United States

Puerto Rico3 sites

  • Study site

    Hato Rey

  • Study site

    Rio Grande

  • Study site

    San Juan

Other trials in Puerto Rico

About this study

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.

Read the 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)

Being tested
Patients with Atrial Fibrillation (AF)
Keywords
Irregular heart beat
Medical subject headings
Atrial Fibrillation, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patients with Atrial Fibrillation (AF)Other

    Treatment patterns of AF according to patient demographics, clinical factors, risk stratification, and geographic regions.

Study groups in NCT01165710
Study groupRoleWhat they receive
001Patients with Atrial Fibrillation (AF) Treatment patterns of AF according to patient demographics clinical factors risk stratification and geographic regions.
Receives: Other: Patients with Atrial Fibrillation (AF)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 years

Secondary outcomes (1)

  1. The number of major adverse cardiac events.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionNov 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,179 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01165710
Sponsor's protocol ID
CR016327
Other IDs
RIVAROXAFL4001
Status last verified
Jan 2017
First submitted
16 Jul 2010
Last updated
24 Jan 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 33892489

  • Steinberg 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.

    PubMed 32298144

  • Holmes 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.

    PubMed 31092022

  • Thind 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.

    PubMed 30227964

  • Durheim 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.

    PubMed 29875139

  • O'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.

    PubMed 29678813

  • Fox 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.

    PubMed 29273652

  • Piccini 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.

    PubMed 27438106

  • Golwala 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.

    PubMed 26995367

  • Jackson 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.

    PubMed 26720750

  • Steinberg 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.

    PubMed 26370445

  • Holmqvist 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.

    PubMed 25999401

  • Holmqvist 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.

    PubMed 25965712

  • Steinberg 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.

    PubMed 25499873

  • Steinberg 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.

    PubMed 24766985

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Janssen Scientific Affairs, LLC at 171 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 171 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01165710, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2017.

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