<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02252575</url>
  </required_header>
  <id_info>
    <org_study_id>GER-EP-014</org_study_id>
    <nct_id>NCT02252575</nct_id>
  </id_info>
  <brief_title>Assessment of Electromagnetic Interference Between E-transportation and Cardiac Implantable Electronic Devices</brief_title>
  <official_title>Assessment of Electromagnetic Interference Between E-transportation and Cardiac Implantable Electronic Devices</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Deutsches Herzzentrum Muenchen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Deutsches Herzzentrum Muenchen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      E-Transportation is increasing all over the world. It is not known if the used engines&#xD;
      interfere with cardiac implantable electronic devices. The study evaluates such potential&#xD;
      interferences in vivo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      E-Transportation is increasing all over the world. It is not known if the used engines&#xD;
      interfere with cardiac implantable electronic devices. The study evaluates different types of&#xD;
      electric motors with regard to electromagnetic interference with implanted pacemakers or&#xD;
      cardioverter-defibrillators.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of electromagnetic interference</measure>
    <time_frame>acute setting</time_frame>
    <description>Occurrence of electromgantic interference during an exposure time of approximately 5 minutes</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">107</enrollment>
  <condition>Electromagnetic Interference</condition>
  <arm_group>
    <arm_group_label>Electromagnetic field</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exposure to the elctromagnetic field of an electric motor</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electromagnetic field</intervention_name>
    <description>Exposure to the electromagnetic fields of electric motors</description>
    <arm_group_label>Electromagnetic field</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  implanted cardiac implantable electronic device with regular function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  implanted cardiac implantable electronic device with irregular function&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christof Kolb, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Deutsches Herzzentrum München</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Deutsches Herzzentrum Muenchen</name>
      <address>
        <city>Munich</city>
        <zip>80636</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <last_update_submitted>February 1, 2018</last_update_submitted>
  <last_update_submitted_qc>February 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02252575
org study id: GER-EP-014
nct id: NCT02252575
lead sponsor: 
has dmc: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Occurrence of electromagnetic interference
time frame: acute setting
description: Occurrence of electromgantic interference during an exposure time of approximately 5 minutes
arm group label: Electromagnetic field
arm group type: Experimental
description: Exposure to the elctromagnetic field of an electric motor
intervention type: Device
intervention name: Electromagnetic field
description: Exposure to the electromagnetic fields of electric motors
arm group label: Electromagnetic field
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christof Kolb, MD
role: Study Chair
affiliation: Deutsches Herzzentrum München
facility: 
country: Germany
responsible party type: Sponsor