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

This study has been completed.

First Received on January 18, 2006. Last Updated on December 10, 2008 History of Changes

Sponsor:	Medtronic Cardiac Rhythm Disease Management
Collaborator:	Medtronic
Information provided by:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT00279981

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:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Arrhythmia Atrial Fibrillation Heart Failure

U.S. FDA Resources

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.

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.

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

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):

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. Epub 2009 Aug 4.

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 February 09, 2012