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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00279981




Registration number
NCT00279981
Ethics application status
Date submitted
18/01/2006
Date registered
20/01/2006
Date last updated
11/12/2008

Titles & IDs
Public title
TRENDS: A Prospective Study of the Clinical Significance of Atrial Arrhythmias Detected by Implanted Device Diagnostics
Scientific title
TRENDS: A Prospective Study of the Clinical Significance of Atrial Arrhythmias Detected by Implanted Device Diagnostics
Secondary ID [1] 0 0
219
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Stroke 0 0
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Diagnostic

Treatment: Devices: Diagnostic
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2007
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
- Liverpool
Recruitment hospital [2] 0 0
- New Lambton
Recruitment hospital [3] 0 0
- Bedford Park
Recruitment hospital [4] 0 0
- Perth-Western Australia
Recruitment postcode(s) [1] 0 0
- Liverpool
Recruitment postcode(s) [2] 0 0
- New Lambton
Recruitment postcode(s) [3] 0 0
- Bedford Park
Recruitment postcode(s) [4] 0 0
- Perth-Western Australia
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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Connecticut
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United States of America
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Delaware
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District of Columbia
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United States of America
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Florida
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Georgia
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Idaho
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
Country [21] 0 0
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Nebraska
Country [22] 0 0
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New Hampshire
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State/province [23] 0 0
New Jersey
Country [24] 0 0
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New York
Country [25] 0 0
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State/province [25] 0 0
North Carolina
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State/province [26] 0 0
Ohio
Country [27] 0 0
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Oklahoma
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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United States of America
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Virginia
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United States of America
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Washington
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United States of America
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Wisconsin
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Canada
State/province [35] 0 0
Alberta
Country [36] 0 0
Canada
State/province [36] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Cardiac Rhythm and Heart Failure
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Medtronic
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00279981
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Emile Daoud, MD
Address 0 0
Riverside Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00279981