<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/NCT03016390</url>
  </required_header>
  <id_info>
    <org_study_id>MED-2559-03815</org_study_id>
    <nct_id>NCT03016390</nct_id>
  </id_info>
  <brief_title>Electromagnetic Interference and Automobile Remote Keyless Entry in Cardiovascular Implantable Electronic Device (CIED) Patients</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chiang Mai University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Thailand Research Fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chiang Mai University</source>
  <brief_summary>
    <textblock>
      Cardiovascular Implantable Electronic device (CIED) is a evolution therapy and number of&#xD;
      patients with it are growing rapidly. Electromagnetic interference causing device malfunction&#xD;
      is not uncommon, Radiofrequency Identification system is among its plausible source. Patients&#xD;
      with CIEDs are at risk of exposure to this novel product in their daily living especially&#xD;
      automobile keyless access system. Only informal studies have been conducted and not be&#xD;
      published. Formal and systemic evaluation and tests are crucial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>April 2016</start_date>
  <primary_completion_date type="Anticipated">April 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of any Electromagnetic interference</measure>
    <time_frame>Immediately after completion of the protocol test</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of pacing inhibition in ventricular channel</measure>
    <time_frame>Immediately after completion of the protocol test</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of noise reversion</measure>
    <time_frame>Immediately after completion of the protocol test</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of ventricular tachycardia/fibrillation detection</measure>
    <time_frame>Immediately after completion of the protocol test</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Electromagnetic Interference in Cardiovascular Implantable Electronic Device</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients participated at our Cardiac Rhythm Device Management (CRDM) clinic at Maharaj&#xD;
        Nakorn Chiang Mai hospital, Faculty of medicine, Chiang Mai University will be invited. And&#xD;
        at least 100 consecutive patients to be equally enrolled in both pacemakers(including&#xD;
        single chamber, dual chamber and Cardiac Resynchronization Therapy pacemaker-CRTP) and&#xD;
        Automatic Implantable Cardioverter-Defibrillator (AICD) (including single chamber, dual&#xD;
        chamber and Bi-ventricular AICD or CRTD)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age more than 18 years old&#xD;
&#xD;
          2. Able to give informed consent&#xD;
&#xD;
          3. Implanted with functioning pacemakers or AICD more than 3 months&#xD;
&#xD;
          4. Adequate and stable all device parameters&#xD;
&#xD;
          5. Able to operate self triggering event recorders (at least 30 seconds)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient with single chamber (Atrial) pacemaker (AAI or AAIR)&#xD;
&#xD;
          2. Presence of unstable hemodynamic or conditions&#xD;
&#xD;
          3. Presence of sustained or ongoing arrhythmia, besides atrial fibrillation/atrial&#xD;
             flutter in single (ventricle) chamber device or Atrio-ventricular block&#xD;
&#xD;
          4. Documented of over-sensing episodes under regular sensitivity threshold (0.25 mV or&#xD;
             more in the atrial channel and 0.75 mV or more in the ventricular channel, for&#xD;
             permanent pacemaker device, and manufacture default setting in Automatic Implantable&#xD;
             Cardioverter-Defibrillator, AICD)&#xD;
&#xD;
          5. Lack of noise oversensing detection/trigger and Electrogram (EGM) storage capability&#xD;
&#xD;
          6. Lack of tachyarrhythmia detection and episode storage capability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arintaya Phrommintikul, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Faculty of Medicine, Chiang Mai University</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>January 9, 2017</last_update_submitted>
  <last_update_submitted_qc>January 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chiang Mai University</investigator_affiliation>
    <investigator_full_name>Narawudt Prasertwitayakij</investigator_full_name>
    <investigator_title>lecturer</investigator_title>
  </responsible_party>
  <keyword>Cardiac Implantable Electronic Device</keyword>
  <keyword>Pacemaker</keyword>
  <keyword>Automatic Implantable Cardioverter-Defibrillator (AICD)</keyword>
  <keyword>Electromagnetic interference (EMI)</keyword>
  <keyword>Keyless access system</keyword>
  <keyword>Keyless entry system</keyword>
  <!-- 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/NCT03016390
org study id: MED-2559-03815
nct id: NCT03016390
lead sponsor: 
collaborator: 
Cardiovascular Implantable Electronic device (CIED) is a evolution therapy and number of
      patients with it are growing rapidly. Electromagnetic interference causing device malfunction
      is not uncommon, Radiofrequency Identification system is among its plausible source. Patients
      with CIEDs are at risk of exposure to this novel product in their daily living especially
      automobile keyless access system. Only informal studies have been conducted and not be
      published. Formal and systemic evaluation and tests are crucial.
observational model: Case-Crossover
time perspective: Prospective
measure: Incidence of any Electromagnetic interference
time frame: Immediately after completion of the protocol test
measure: Incidence of pacing inhibition in ventricular channel
time frame: Immediately after completion of the protocol test
measure: Incidence of noise reversion
time frame: Immediately after completion of the protocol test
measure: Incidence of ventricular tachycardia/fibrillation detection
time frame: Immediately after completion of the protocol test
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Arintaya Phrommintikul, MD
role: Study Chair
affiliation: Faculty of Medicine, Chiang Mai University
responsible party type: Principal Investigator
investigator affiliation: Chiang Mai University
investigator full name: Narawudt Prasertwitayakij
investigator title: lecturer