Examination of Implant´s Safety in an Electronic and Magnetic Field Environment (FEMU)

RWTH Aachen University

Status: Completed

Conditions: Disorder of Cardiac Pacemaker System; Disorder of Implantable Defibrillator; Cardiac Arrhythmia

Treatments: Device: Magnetic and electric field´s impact on the implant

Study type: Observational

Funder types: Other

Identifiers

NCT01626261

09-051

Details and patient eligibility

About

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.

Enrollment: 281 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

281 participants in 1 patient group

cardiac pacemaker

Treatment:

Device: Magnetic and electric field´s impact on the implant