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OpenTrials
Completed

NCT Number: NCT01626261

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

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.

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Key information

Conditions

Disorder of Cardiac Pacemaker System Arrhythmias, Cardiac Cardiac Arrhythmia Cardiovascular Diseases Disorder of Implantable Defibrillator Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universtiy Hospital RWTH Aachen

Aachen, Northrhine-Westfalia, 52074, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic and electric field´s impact on the implant

Device

Examination of magnetic and electric field's impact on the implant regarding: stability detection threshold using different strength of magnetic and electric field

Other names: Examination

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Official study title

Study of Provocation Concerning Implants´Safety in Electronic and Magnetic Fields in Their Environment

Acronym: FEMU

Important dates

Study start
2009
Primary completion
2018
Study completion
2018
First posted
Jun 22, 2012
Registry last updated
Jun 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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