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Clinical Trials/NCT01626261
NCT01626261
Completed
N/A

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

RWTH Aachen University1 site in 1 country281 target enrollmentSeptember 2009

Overview

Phase
N/A
Intervention
Not specified
Conditions
Disorder of Cardiac Pacemaker System
Sponsor
RWTH Aachen University
Enrollment
281
Locations
1
Primary Endpoint
Interference threshold of the device in electromagnetic fields in V/m and/or µT
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
June 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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