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

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ClinicalTrials.gov Identifier: NCT01626261
Recruitment Status : Unknown
Verified April 2015 by RWTH Aachen University.
Recruitment status was:  Recruiting
First Posted : June 22, 2012
Last Update Posted : May 1, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Disorder of Cardiac Pacemaker System Disorder of Implantable Defibrillator Cardiac Arrhythmia Device: Magnetic and electric field´s impact on the implant

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Provocation Concerning Implants´Safety in Electronic and Magnetic Fields in Their Environment
Study Start Date : September 2009
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
cardiac pacemaker 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
Other Name: Examination

Outcome Measures

Primary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples Without DNA
blood (serum and plasma) urine

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
age between 18 and 80

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01626261

Contact: Andreas Napp, MD +49241800 anapp@ukaachen.de
Contact: Nikolaus Marx, MD +49241800 nmarx@ukaachen.de

Universtiy Hospital of Aachen Recruiting
Aachen, Northrhine-Westfalia, Germany, 52074
Contact: Andreas Napp, MD    +49241800    anapp@ukaachen.de   
Sponsors and Collaborators
RWTH Aachen University
Principal Investigator: Andreas Napp, MD University Hospital, Aachen
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01626261     History of Changes
Other Study ID Numbers: 09-051
First Posted: June 22, 2012    Key Record Dates
Last Update Posted: May 1, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Pathologic Processes
Heart Diseases
Cardiovascular Diseases