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

Overview

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.

Full Title of Study: “Study of Provocation Concerning Implants´Safety in Electronic and Magnetic Fields in Their Environment”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2018

Interventions

  • 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

Arms, Groups and Cohorts

  • cardiac pacemaker

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • RWTH Aachen University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Andreas Napp, MD, Principal Investigator, University Hospital, Aachen

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