Cardiac Arrhythmia Clinical Trial
Official title:
Study of Provocation Concerning Implants´Safety in Electronic and Magnetic Fields in Their Environment
The number of active electrical cardiac implants such as internal cardioverter defibrillators
(ICDs), pacemakers or cardiac contractility modules (CCM) has significantly risen over the
last two decades. This has been paralleled by an increase in the number of sources of
electromagnetic fields in daily life and occupational circumstances.
To date it remains unclear whether patients are at risk of device failure when being
subjected to these fields. There are currently no general guidelines available to help
clinicians informing their patients about safety levels and behavior around these
electromagnetic fields.
This study aims to identify the thresholds of safe use of these devices and potential
failures under worst-case conditions in 50/60 Hz fields (i.e.
power line frequency). Device implanted patients will be exposed to electric, magnetic and
combined fields of different intensity at various device programming (e.g. nominal and
maximum sensitivity). The results will show whether patients are safe in public or
occupational environments, which medical relevant disturbances can occur and if a correlation
exists between disturbances and device type or patients physique.
n/a
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