Status:
COMPLETED
TRENDS: A Prospective Study of the Clinical Significance of Atrial Arrhythmias Detected by Implanted Device Diagnostics
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Collaborating Sponsors:
Medtronic
Conditions:
Atrial Fibrillation
Stroke
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
OBSERVATIONAL
End Date :
June 1 2007
Estimated Enrollment :
3100 Patients enrolled
Trial Details
Trial ID
NCT00279981
Start Date
November 1 2003
End Date
June 1 2007
Last Update
December 11 2008
Active Locations (98)
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1
Mesa, Arizona, United States
2
Tucson, Arizona, United States
3
Fountain Valley, California, United States
4
Mission Viejo, California, United States