Electromagnetic Interference Clinical Trial
Official title:
Evaluation of Interference Between Cell Phones and Implantable Cardioverter Defibrillators
Evaluation of electromagnetic interference between modern cell phones and contemporary implantable cardioverter defibrillators (ICDs)
Electrograms of ICDs will be analyzed during wireless telemetry and during exposure to an
activated cell phone. ICD therapy will have been temporarily inactivated before exposure to
cell phones to avoid inappropriate shocks, and the sensitivity level of the ICD will be set
to maximum. The cell phones will be held over the ICD generator, as well as in the
parasternar region (close to the ICD lead, which senses the signals).
Interference will be assessed by the presence of visible artefacts on the real-time
electrogram, with ICD marker annotations showing atrial and/or ventricular sensed episodes.
The outcome measure will be the number and proportion of patients who have electromagnetic
interference of the ICD when exposed to cell phones.
The procedure will take approximately 5-10minutes, with reprogramming of the device at the
end of the test. No further follow-up in the context of the study will be performed.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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