<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/NCT03264222</url>
  </required_header>
  <id_info>
    <org_study_id>GER-EP-017</org_study_id>
    <nct_id>NCT03264222</nct_id>
  </id_info>
  <brief_title>Safety of a New Security Device in Patients With Implanted Cardiac Electronic Devices</brief_title>
  <official_title>Safety of a New Security Device in Patients With Implanted Cardiac Electronic Devices</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Deutsches Herzzentrum Muenchen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bayerisches Staatsministerium für Wirtschaft</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>R &amp; S GmbH und Co KG</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Deutsches Herzzentrum Muenchen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with implantable cardiac electronic devices will be exposed to a new safety device&#xD;
      and evaluated for potential electromagnetic interference.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with implanted pacemakers or defibrillators will undergo a screening procedure with&#xD;
      an innovative security device. Evaluation will be made with respect to the occurrence of&#xD;
      interference.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">October 31, 2018</completion_date>
  <primary_completion_date type="Actual">July 12, 2018</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>
    <intervention_model_description>Prospective cohort study.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Electromagnetic interference</measure>
    <time_frame>10 minutes</time_frame>
    <description>Occurrence of electromagnetic interference</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">379</enrollment>
  <condition>Electromagnetic Interference</condition>
  <arm_group>
    <arm_group_label>Exposition to safety screening</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>One armed study with exposition to a new safety device (model QPS100) using radiofrequency technology</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Security screening procedure</intervention_name>
    <description>Screening procedure with security device (model QPS 100)</description>
    <arm_group_label>Exposition to safety screening</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  implantable pacemaker or defibrillator in situ&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  malfunction of implantable pacemaker or defibrillator&#xD;
&#xD;
          -  low battery voltage of implanted cardiac electronic device&#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>Principal Investigator</role>
    <affiliation>Deutsches Herzzentrum München</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Deutsches Herzzentrum München</name>
      <address>
        <city>Munich</city>
        <state>Bavaria</state>
        <zip>80636</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>July 31, 2021</last_update_submitted>
  <last_update_submitted_qc>July 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03264222
org study id: GER-EP-017
nct id: NCT03264222
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with implantable cardiac electronic devices will be exposed to a new safety device
      and evaluated for potential electromagnetic interference.
Patients with implanted pacemakers or defibrillators will undergo a screening procedure with
      an innovative security device. Evaluation will be made with respect to the occurrence of
      interference.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective cohort study.
primary purpose: Prevention
masking: None (Open Label)
measure: Electromagnetic interference
time frame: 10 minutes
description: Occurrence of electromagnetic interference
arm group label: Exposition to safety screening
arm group type: Other
description: One armed study with exposition to a new safety device (model QPS100) using radiofrequency technology
intervention type: Other
intervention name: Security screening procedure
description: Screening procedure with security device (model QPS 100)
arm group label: Exposition to safety screening
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christof Kolb, MD
role: Principal Investigator
affiliation: Deutsches Herzzentrum München
facility: 
country: Germany
responsible party type: Sponsor
sharing ipd: No