MedTrace Logo

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

NCT01626261 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 281

Last updated 2018-06-15

No results posted yet for this study

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.

Conditions

  • Disorder of Cardiac Pacemaker System
  • Disorder of Implantable Defibrillator
  • Cardiac Arrhythmia

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

Sponsors & Collaborators

  • RWTH Aachen University

    lead OTHER

Principal Investigators

  • Andreas Napp, MD · University Hospital, Aachen

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01626261 on ClinicalTrials.gov