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

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00279981
First received: January 18, 2006
Last updated: December 10, 2008
Last verified: December 2008
  Purpose

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 Intervention
Atrial Fibrillation
Stroke
Heart Failure
Device: Diagnostic

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: TRENDS: A Prospective Study of the Clinical Significance of Atrial Arrhythmias Detected by Implanted Device Diagnostics

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Estimated Enrollment: 3100
Study Start Date: November 2003
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00279981

  Show 100 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Medtronic
Investigators
Principal Investigator: Emile Daoud, MD Riverside Hospital
Principal Investigator: Taya Glotzer, MD Hackensack University Medical Center
  More Information

No publications provided by Medtronic Cardiac Rhythm Disease Management

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00279981     History of Changes
Other Study ID Numbers: 219
Study First Received: January 18, 2006
Last Updated: December 10, 2008
Health Authority: United States: Institutional Review Board
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Atrial fibrillation
Stroke
Pacemaker
Implantable Cardiac Defibrillator
Resynchronization systems

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Atrial Fibrillation
Heart Failure
Stroke
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 26, 2014