Assessment of Electromagnetic Interference Between E-transportation and Cardiac Implantable Electronic Devices

February 1, 2018 updated by: Deutsches Herzzentrum Muenchen
E-Transportation is increasing all over the world. It is not known if the used engines interfere with cardiac implantable electronic devices. The study evaluates such potential interferences in vivo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

E-Transportation is increasing all over the world. It is not known if the used engines interfere with cardiac implantable electronic devices. The study evaluates different types of electric motors with regard to electromagnetic interference with implanted pacemakers or cardioverter-defibrillators.

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

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
      • Munich, Germany, 80636
        • Deutsches Herzzentrum Muenchen

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • implanted cardiac implantable electronic device with regular function

Exclusion Criteria:

  • implanted cardiac implantable electronic device with irregular function

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electromagnetic field
Exposure to the elctromagnetic field of an electric motor
Device: Electromagnetic field
Exposure to the electromagnetic fields of electric motors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of electromagnetic interference
Time Frame: acute setting
Occurrence of electromgantic interference during an exposure time of approximately 5 minutes
acute setting

Collaborators and Investigators

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

Sponsor

Deutsches Herzzentrum Muenchen

Investigators

  • Study Chair: Christof Kolb, MD, Deutsches Herzzentrum München

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 (Actual)

September 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

September 26, 2014

First Submitted That Met QC Criteria

September 26, 2014

First Posted (Estimate)

September 30, 2014

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

February 1, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • GER-EP-014

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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