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Atrial FibrillationNCT00279981

TRENDS: A Prospective Study of the Clinical Significance of Atrial Arrhythmias Detected by Implanted Device Diagnostics

An observational study of Atrial Fibrillation and Stroke, run by Medtronic Cardiac Rhythm and Heart Failure at 98 sites in 3 countries.

Completed

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

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation, Stroke, Heart Failure
What is being tested?
Diagnostic
Type of treatment
Medical device
How many people
3,100 participants
Where
98 sitesin 3 countries
Study dates
Nov 2003to Jun 2007
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject provides written informed consent and privacy/protection authorization.
  • 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)
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

98 sites in 3 countries.

98 sites in 3 countries

United States92 sites

  • Study site

    Ames, Iowa

  • Study site

    Ashland, Kentucky

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Baltimore, Maryland

  • Study site

    Boise, Idaho

  • Study site

    Boston, Massachusetts

  • Study site

    Brighton, Massachusetts

  • Study site

    Brooklyn, New York

  • Study site

    Burlington, Massachusetts

  • Study site

    Camden, New Jersey

  • Study site

    Charleston, South Carolina

  • Study site

    Charlottesville, Virginia

  • Study site

    Chattanooga, Tennessee

  • Study site

    Cherry Hill, New Jersey

  • Study site

    Chicago, Illinois

  • Study site

    Cleveland, Ohio

  • Study site

    Columbia, South Carolina

  • Study site

    Columbus, Ohio

  • Study site

    Corpus Christi, Texas

  • Study site

    Covington, Louisiana

  • Study site

    Dallas, Texas

  • Study site

    Duluth, Minnesota

  • Study site

    Easton, Pennsylvania

  • Study site

    Fairview Park, Ohio

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Fort Worth, Texas

  • Study site

    Fountain Valley, California

  • Study site

    Grand Blanc, Michigan

  • Study site

    Greensboro, North Carolina

  • Study site

    Greenville, South Carolina

  • Study site

    Gulfport, Mississippi

  • Study site

    Hackensack, New Jersey

  • Study site

    Haddon Heights, New Jersey

  • Study site

    Hagerstown, Maryland

  • Study site

    Hattiesburg, Mississippi

  • Study site

    Hollywood, Florida

  • Study site

    Houston, Texas

  • Study site

    Indianapolis, Indiana

  • Study site

    Kalamazoo, Michigan

  • Study site

    Knoxville, Tennessee

  • Study site

    La Crosse, Wisconsin

  • Study site

    Lebanon, New Hampshire

  • Study site

    Lexington, Kentucky

  • Study site

    Lincoln, Nebraska

  • Study site

    Marion, Ohio

  • Study site

    Melbourne, Florida

  • Study site

    Memphis, Tennessee

  • Study site

    Mesa, Arizona

  • Study site

    Midwest City, Oklahoma

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Minneapolis, Minnesota

  • Study site

    Mission Viejo, California

  • Study site

    Modesto, California

  • Study site

    Mount Clemens, Michigan

  • Study site

    Munster, Indiana

  • Study site

    Naples, Florida

  • Study site

    Nashville, Tennessee

  • Study site

    National City, California

  • Study site

    New York, New York

  • Study site

    Newark, Delaware

  • Study site

    Norfolk, Virginia

  • Study site

    Norwalk, Connecticut

  • Study site

    Odessa, Texas

  • Study site

    Omaha, Nebraska

  • Study site

    Palm Beach Gardens, Florida

  • Study site

    Palm Springs, California

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pinehurst, North Carolina

  • Study site

    Poughkeepsie, New York

  • Study site

    Raleigh, North Carolina

  • Study site

    Richmond, Virginia

  • Study site

    Saginaw, Michigan

  • Study site

    Saint Paul, Minnesota

  • Study site

    Salinas, California

  • Study site

    San Bernadino, California

  • Study site

    Slidell, Louisiana

  • Study site

    Spokane, Washington

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    Syracuse, New York

  • Study site

    Takoma Park, Maryland

  • Study site

    Toledo, Ohio

  • Study site

    Torrance, California

  • Study site

    Tucson, Arizona

  • Study site

    Tupelo, Mississippi

  • Study site

    Tyler, Texas

  • Study site

    Washington D.C., District of Columbia

  • Study site

    West Orange, New Jersey

  • Study site

    Wichita, Kansas

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Worcester, Massachusetts

Other trials in United States

Australia4 sites

  • Study site

    Bedford Park, South Australia

  • Study site

    Liverpool, New South Wales

  • Study site

    New Lambton, New South Wales

  • Study site

    Perth-Western Australia

Other trials in Australia

Canada2 sites

  • Study site

    Calgary, Alberta

  • Study site

    London, Ontario

Other trials in Canada

About this study

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.

Being tested
Diagnostic
Keywords
Atrial fibrillation, Stroke, Pacemaker, Implantable Cardiac Defibrillator, Resynchronization systems
Medical subject headings
Atrial Fibrillation, Stroke, Heart Failure

What participants receive

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

  • DiagnosticDevice

Timeline

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

  1. First posted20 Jan 2006 (estimated)
  2. Study startNov 2003
  3. Primary completionJun 2007
  4. Study completionJun 2007

Resources

More details

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

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
3,100 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00279981
Sponsor's protocol ID
219
Status last verified
Dec 2008
First submitted
18 Jan 2006
Last updated
11 Dec 2008
Results posted
No

Publications

  • 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.

    PubMed 26882334

  • 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.

    PubMed 19843914

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation and Stroke, run by Medtronic Cardiac Rhythm and Heart Failure at 98 sites in 3 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 11 inclusion and 7 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 11 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in United States, Australia, Canada. 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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00279981, which also lists 2 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 11 Dec 2008.

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