<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/NCT02191696</url>
  </required_header>
  <id_info>
    <org_study_id>CP-000050</org_study_id>
    <nct_id>NCT02191696</nct_id>
  </id_info>
  <brief_title>Observational Study of ICD and Pacemaker Sensing in the Presence of IMED-4 Operation</brief_title>
  <official_title>Observational Study of ICD and Pacemaker Sensing in the Presence of IMED-4 Operation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intersection Medical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Intersection Medical, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose is to monitor far field sensing artifacts of CRM devices in the presence of the&#xD;
      IMED-4&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The implanted CRM device will have shock therapy and rate sensor temporarily deactivated or&#xD;
      placed in magnet mode during the time the IMED-4 is activated. The IMED-4 will be activated&#xD;
      for a time not to exceed 15 minutes. During the time the IMED-4 is active, the CRM device&#xD;
      programmer will print the voltage sensing of the implanted lead in real-time. The printout&#xD;
      will be examined for the presence of far-field sensing artifacts.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>IMED-4 recordings</measure>
    <time_frame>6 months</time_frame>
    <description>The primary endpoint is a collection of CRM device programmer printouts containing real-time lead sensing data from up to 40 unique subjects.</description>
  </primary_outcome>
  <enrollment type="Actual">24</enrollment>
  <condition>Heart Failure</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IMED-4 recording</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who present for CRM device follow-up are possible candidates for the study and&#xD;
        shall be screened for suitability based on the inclusion and exclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with an active implantable CRM device&#xD;
&#xD;
          -  Subjects &gt; 18 years of age&#xD;
&#xD;
          -  Subjects who are ambulatory not requiring assistance for ambulation&#xD;
&#xD;
          -  Subjects who have been informed of the nature of the study and agree to its provisions&#xD;
             and have provided written informed consent as approved by the IRB&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who are pregnant or lactating or who have been pregnant within the past three&#xD;
             months&#xD;
&#xD;
          -  Subjects who have tattoos on the back in the electrode patch placement region&#xD;
&#xD;
          -  Subjects who have had a past allergic reaction to adhesives&#xD;
&#xD;
          -  Subjects who have poor general physical/mental health that, in the opinion of the&#xD;
             investigator, will not allow the subject to be a good study candidate (i.e. other&#xD;
             disease processes, mental capacity, substance abuse, shortened life expectance, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>North Coast Cardiology</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Desert Heart</name>
      <address>
        <city>Palm Springs</city>
        <state>California</state>
        <zip>92262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>January 28, 2015</last_update_submitted>
  <last_update_submitted_qc>January 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <!-- 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/NCT02191696
org study id: CP-000050
nct id: NCT02191696
lead sponsor: 
has dmc: No
The purpose is to monitor far field sensing artifacts of CRM devices in the presence of the
      IMED-4
The implanted CRM device will have shock therapy and rate sensor temporarily deactivated or
      placed in magnet mode during the time the IMED-4 is activated. The IMED-4 will be activated
      for a time not to exceed 15 minutes. During the time the IMED-4 is active, the CRM device
      programmer will print the voltage sensing of the implanted lead in real-time. The printout
      will be examined for the presence of far-field sensing artifacts.
observational model: Case-Only
time perspective: Prospective
measure: IMED-4 recordings
time frame: 6 months
description: The primary endpoint is a collection of CRM device programmer printouts containing real-time lead sensing data from up to 40 unique subjects.
intervention type: Device
intervention name: IMED-4 recording
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Heart Failure