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

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ClinicalTrials.gov Identifier: NCT00279981
Recruitment Status : Completed
First Posted : January 20, 2006
Last Update Posted : December 11, 2008
Sponsor:
Collaborator:
Medtronic
Information provided by:
Medtronic Cardiac Rhythm and Heart Failure

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.

Condition or disease Intervention/treatment
Atrial Fibrillation Stroke Heart Failure Device: Diagnostic

Study Type : Observational
Enrollment : 3100 participants
Time Perspective: Prospective
Official Title: TRENDS: A Prospective Study of the Clinical Significance of Atrial Arrhythmias Detected by Implanted Device Diagnostics
Study Start Date : November 2003
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)
  • 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00279981


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Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Medtronic
Investigators
Principal Investigator: Emile Daoud, MD Riverside Hospital
Principal Investigator: Taya Glotzer, MD Hackensack University Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00279981     History of Changes
Other Study ID Numbers: 219
First Posted: January 20, 2006    Key Record Dates
Last Update Posted: December 11, 2008
Last Verified: December 2008

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
Atrial fibrillation
Stroke
Pacemaker
Implantable Cardiac Defibrillator
Resynchronization systems

Additional relevant MeSH terms:
Heart Failure
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes