Examination of Implant´s Safety in an Electronic and Magnetic Field Environment (FEMU)
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|ClinicalTrials.gov Identifier: NCT01626261|
Recruitment Status : Completed
First Posted : June 22, 2012
Last Update Posted : June 15, 2018
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.
|Condition or disease||Intervention/treatment|
|Disorder of Cardiac Pacemaker System Disorder of Implantable Defibrillator Cardiac Arrhythmia||Device: Magnetic and electric field´s impact on the implant|
|Study Type :||Observational|
|Actual Enrollment :||281 participants|
|Official Title:||Study of Provocation Concerning Implants´Safety in Electronic and Magnetic Fields in Their Environment|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||June 2018|
|Actual Study Completion Date :||June 2018|
Device: Magnetic and electric field´s impact on the implant
Examination of magnetic and electric field's impact on the implant regarding: stability detection threshold using different strength of magnetic and electric field
Other Name: Examination
- Interference threshold of the device in electromagnetic fields in V/m and/or µT [ Time Frame: for every patient during one ambulant visit about 1 hour study examination ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01626261
|Universtiy Hospital RWTH Aachen|
|Aachen, Northrhine-Westfalia, Germany, 52074|
|Principal Investigator:||Andreas Napp, MD||University Hospital, Aachen|