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

Completed

Phase N/A Results N/A

Eligibility 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.