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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00279981
• Date of registration: 18/01/2006
• Primary sponsor: Medtronic Cardiac Rhythm Disease Management
• 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
• Date of first enrolment: November 2003
• Target sample size: 3100
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00279981
• Study type: Observational
• Study design: Time Perspective: Prospective

Countries of recruitment

Australia, Canada, United States

Contacts

• Name: Taya Glotzer, MD
• Affiliation: Hackensack University Medical Center

• Name: Emile Daoud, MD
• Affiliation: Riverside Hospital

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Atrial Fibrillation

Heart Failure

Stroke

Intervention(s)

Device: Diagnostic

Secondary ID(s)

219

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Medtronic