TRENDS: A Prospective Study of the Clinical Significance of Atrial Arrhythmias Detected by Implanted Device Diagnostics
1 other identifier
observational
3,100
3 countries
98
Brief Summary
The purpose of this study is to look at the heart rate and rhythm information collected daily in Medtronic implantable pulse generators (IPG), implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy (CRT) devices. The study will gather this information from many patients to see if heart rate or rhythm data can predict the risk of a patient having a medical condition such as stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2003
Typical duration for all trials
98 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedFirst Submitted
Initial submission to the registry
January 18, 2006
CompletedFirst Posted
Study publicly available on registry
January 20, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedDecember 11, 2008
December 1, 2008
3.6 years
January 18, 2006
December 10, 2008
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Subject provides written informed consent and privacy/protection authorization.
- Subjects 65 years of age or older.
- 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
- 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.
You may not qualify if:
- Subjects who are to receive a replacement IPG, ICD or CRT device.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic Cardiac Rhythm and Heart Failurelead
- Medtroniccollaborator
Study Sites (98)
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Mesa, Arizona, United States
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Tucson, Arizona, United States
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Fountain Valley, California, United States
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Mission Viejo, California, United States
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Modesto, California, United States
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National City, California, United States
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Palm Springs, California, United States
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Salinas, California, United States
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San Bernadino, California, United States
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Torrance, California, United States
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Norwalk, Connecticut, United States
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Newark, Delaware, United States
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Washington D.C., District of Columbia, United States
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Fort Lauderdale, Florida, United States
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Hollywood, Florida, United States
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Melbourne, Florida, United States
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Naples, Florida, United States
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Palm Beach Gardens, Florida, United States
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St. Petersburg, Florida, United States
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Atlanta, Georgia, United States
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Boise, Idaho, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Munster, Indiana, United States
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Ames, Iowa, United States
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Wichita, Kansas, United States
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Ashland, Kentucky, United States
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Lexington, Kentucky, United States
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Covington, Louisiana, United States
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Slidell, Louisiana, United States
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Baltimore, Maryland, United States
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Hagerstown, Maryland, United States
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Takoma Park, Maryland, United States
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Boston, Massachusetts, United States
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Brighton, Massachusetts, United States
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Burlington, Massachusetts, United States
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Worcester, Massachusetts, United States
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Grand Blanc, Michigan, United States
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Kalamazoo, Michigan, United States
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Mount Clemens, Michigan, United States
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Saginaw, Michigan, United States
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Duluth, Minnesota, United States
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Minneapolis, Minnesota, United States
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Saint Paul, Minnesota, United States
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Gulfport, Mississippi, United States
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Hattiesburg, Mississippi, United States
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Tupelo, Mississippi, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Lebanon, New Hampshire, United States
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Camden, New Jersey, United States
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Cherry Hill, New Jersey, United States
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Hackensack, New Jersey, United States
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Haddon Heights, New Jersey, United States
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West Orange, New Jersey, United States
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Brooklyn, New York, United States
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New York, New York, United States
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Poughkeepsie, New York, United States
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Syracuse, New York, United States
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Greensboro, 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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Winston-Salem, North Carolina, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Fairview Park, Ohio, United States
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Marion, Ohio, United States
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Toledo, Ohio, United States
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Midwest City, Oklahoma, United States
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Easton, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Greenville, South Carolina, United States
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Chattanooga, Tennessee, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Odessa, Texas, United States
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Tyler, Texas, United States
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Charlottesville, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Spokane, Washington, United States
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La Crosse, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Liverpool, New South Wales, Australia
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New Lambton, New South Wales, Australia
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Bedford Park, South Australia, Australia
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Perth-Western Australia, Australia
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Calgary, Alberta, Canada
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London, Ontario, Canada
Related Publications (2)
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.
PMID: 26882334DERIVEDGlotzer 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.
PMID: 19843914DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emile Daoud, MD
Riverside Hospital
- PRINCIPAL INVESTIGATOR
Taya Glotzer, MD
Hackensack Meridian Health
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 18, 2006
First Posted
January 20, 2006
Study Start
November 1, 2003
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
December 11, 2008
Record last verified: 2008-12