Clinical trial NCT01626261: Examination of Implant´s Safety in an Electronic and Magnetic Field Environment
Official title: Study of Provocation Concerning Implants´Safety in Electronic and Magnetic Fields in Their Environment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorder of Cardiac Pacemaker System
Disorder of Implantable Defibrillator
Cardiac Arrhythmia
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2012-06-22
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: age between 18 and 80

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* men and women between 18 and 80 years
* Implantation of a Pacemaker (SM)-/ ICD-assembly at least four weeks ago
* signed informed consent

Exclusion Criteria:

* enduring addiction of implant
* thyroid disease
* electrolyte imbalance on the trial day
* pregnancy and breastfeeding
* acute myocardial infarction (\<30 days)
* Comorbidity, which complicates an emergency assistance, e.g. morbus bechterew, glaucoma, micturition disturbance

Primary outcomes:
measure: Interference threshold of the device in electromagnetic fields in V/m and/or µT
timeFrame: for every patient during one ambulant visit about 1 hour study examination
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universtiy Hospital RWTH Aachen
state: Northrhine-Westfalia
Study officials:
affiliation: University Hospital, Aachen
name: Andreas Napp, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Napp A, Joosten S, Stunder D, Knackstedt C, Zink M, Bellmann B, Marx N, Schauerte P, Silny J. Electromagnetic interference with implantable cardioverter-defibrillators at power frequency: an in vivo study. Circulation. 2014 Jan 28;129(4):441-50. doi: 10.1161/CIRCULATIONAHA.113.003081. Epub 2013 Oct 25.