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

June 14, 2018 updated by: RWTH Aachen University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

281

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Northrhine-Westfalia
      • Aachen, Northrhine-Westfalia, Germany, 52074
        • Universtiy Hospital RWTH Aachen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

age between 18 and 80

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • Examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
for every patient during one ambulant visit about 1 hour study examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Investigators

  • Principal Investigator: Andreas Napp, MD, University Hospital, Aachen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

June 20, 2012

First Submitted That Met QC Criteria

June 20, 2012

First Posted (Estimate)

June 22, 2012

Study Record Updates

Last Update Posted (Actual)

June 15, 2018

Last Update Submitted That Met QC Criteria

June 14, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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