TRENDS: A Prospective Study of the Clinical Significance of Atrial Arrhythmias Detected by Implanted Device Diagnostics
NCT ID: NCT00279981
Last Updated: 2008-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
3100 participants
OBSERVATIONAL
2003-11-30
2007-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Diagnostic
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects 65 years of age or older.
OR
* Subjects with age \>18 and \< 65 years and one of the following stroke risk factors:
* Prior stroke or TIA
* Diagnosis of hypertension (HTN)
* Diagnosis of Diabetes Mellitus (DM)
* Diagnosis of Congestive Heart Failure (CHF)
* Subjects who meet the Class I/Class II indications for a dual chamber implantable pulse generator or dual chamber implanted cardioverter defibrillator device
OR
• Subjects who meet the criteria for indication of a dual chamber resynchronization device with bi-ventricular pacing (moderate to severe CHF symptoms \[NYHA Class III-IV\] despite optimal medical therapy, left ventricular ejection fraction ≤ 35%, and a QRS duration ≥130 ms)13.
Exclusion Criteria
* Subjects with chronic (permanent) AT/AF.
* Subjects with a history of AV nodal dependent arrhythmias.
* Subjects with a terminal illness who are not expected to survive more than 6 months.
* Subjects who are unwilling or unable to cooperate or give written informed consent and privacy/protection authorization, or subjects whose legal representatives or legal guardians refuse to give informed consent or privacy/protection authorization.
* Subjects currently receiving treatment in another drug and/or device study which could affect the outcome of the trial.
* Subjects who are or will be inaccessible for follow-up at a qualified study center.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medtronic
INDUSTRY
Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Emile Daoud, MD
Role: PRINCIPAL_INVESTIGATOR
Riverside Hospital
Taya Glotzer, MD
Role: PRINCIPAL_INVESTIGATOR
Hackensack Meridian Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mesa, Arizona, United States
Tucson, Arizona, United States
Fountain Valley, California, United States
Mission Viejo, California, United States
Modesto, California, United States
National City, California, United States
Palm Springs, California, United States
Salinas, California, United States
San Bernadino, California, United States
Torrance, California, United States
Norwalk, Connecticut, United States
Newark, Delaware, United States
Washington D.C., District of Columbia, United States
Fort Lauderdale, Florida, United States
Hollywood, Florida, United States
Melbourne, Florida, United States
Naples, Florida, United States
Palm Beach Gardens, Florida, United States
St. Petersburg, Florida, United States
Atlanta, Georgia, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Munster, Indiana, United States
Ames, Iowa, United States
Wichita, Kansas, United States
Ashland, Kentucky, United States
Lexington, Kentucky, United States
Covington, Louisiana, United States
Slidell, Louisiana, United States
Baltimore, Maryland, United States
Hagerstown, Maryland, United States
Takoma Park, Maryland, United States
Boston, Massachusetts, United States
Brighton, Massachusetts, United States
Burlington, Massachusetts, United States
Worcester, Massachusetts, United States
Grand Blanc, Michigan, United States
Kalamazoo, Michigan, United States
Mount Clemens, Michigan, United States
Saginaw, Michigan, United States
Duluth, Minnesota, United States
Minneapolis, Minnesota, United States
Saint Paul, Minnesota, United States
Gulfport, Mississippi, United States
Hattiesburg, Mississippi, United States
Tupelo, Mississippi, United States
St Louis, Missouri, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Lebanon, New Hampshire, United States
Camden, New Jersey, United States
Cherry Hill, New Jersey, United States
Hackensack, New Jersey, United States
Haddon Heights, New Jersey, United States
West Orange, New Jersey, United States
Brooklyn, New York, United States
New York, New York, United States
Poughkeepsie, New York, United States
Syracuse, New York, United States
Greensboro, North Carolina, United States
Pinehurst, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Fairview Park, Ohio, United States
Marion, Ohio, United States
Toledo, Ohio, United States
Midwest City, Oklahoma, United States
Easton, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Greenville, South Carolina, United States
Chattanooga, Tennessee, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Odessa, Texas, United States
Tyler, Texas, United States
Charlottesville, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Spokane, Washington, United States
La Crosse, Wisconsin, United States
Milwaukee, Wisconsin, United States
Liverpool, New South Wales, Australia
New Lambton, New South Wales, Australia
Bedford Park, South Australia, Australia
Perth-Western Australia, , Australia
Calgary, Alberta, Canada
London, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Yano Y, Greenland P, Lloyd-Jones DM, Daoud EG, Koehler JL, Ziegler PD. Simulation of Daily Snapshot Rhythm Monitoring to Identify Atrial Fibrillation in Continuously Monitored Patients with Stroke Risk Factors. PLoS One. 2016 Feb 16;11(2):e0148914. doi: 10.1371/journal.pone.0148914. eCollection 2016.
Glotzer TV, Daoud EG, Wyse DG, Singer DE, Ezekowitz MD, Hilker C, Miller C, Qi D, Ziegler PD. The relationship between daily atrial tachyarrhythmia burden from implantable device diagnostics and stroke risk: the TRENDS study. Circ Arrhythm Electrophysiol. 2009 Oct;2(5):474-80. doi: 10.1161/CIRCEP.109.849638. Epub 2009 Aug 4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
219
Identifier Type: -
Identifier Source: org_study_id