<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/NCT03772704</url>
  </required_header>
  <id_info>
    <org_study_id>18-1480</org_study_id>
    <nct_id>NCT03772704</nct_id>
  </id_info>
  <brief_title>Multicenter Imaging in Lead Extraction Study</brief_title>
  <acronym>MILES</acronym>
  <official_title>Multicenter Imaging in Lead Extraction Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Philips Healthcare</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>The Cleveland Clinic</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>
      The primary objectives of this registry is to correlate the amount of fibrosis as documented&#xD;
      on Electrocardiogram (ECG) gated Computed Tomography (CT) scans with ease of advancing&#xD;
      sheaths over the leads through the SVC zone during lead extraction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-center, prospective, observational registry study which plans to enroll&#xD;
      approximately 200 patients referred for Cardiac Implantable Electronic Device(CIED) lead&#xD;
      extraction at one of the five study centers. The objective of this study is to determine&#xD;
      whether a correlation exists between fibrosis detected on ECG gated cardiac CT and the ease&#xD;
      of lead extraction as measured by need for extraction energy. All patients will be followed&#xD;
      for 30 days post-lead extraction to assess vital status and re-hospitalizations via phone&#xD;
      call&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 13, 2018</start_date>
  <completion_date type="Actual">November 4, 2020</completion_date>
  <primary_completion_date type="Actual">November 4, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>30 Days</target_duration>
  <primary_outcome>
    <measure>Correlation of the presence and degree of fibrosis as determined by ECG gated cardiac CT with the presence and degree of fibrosis determined by ease of extraction sheath advancement</measure>
    <time_frame>30 days</time_frame>
    <description>The presence and degree of fibrosis determined by the ease of extraction sheath advancement will be evaluated in three zones. Zone 1 will be the area before the Superior Vena Cava (SVC), Zone 2 in the SVC and Zone 3 after the SVC</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of ECG gated CT scans that show fibrosis</measure>
    <time_frame>30 days</time_frame>
    <description>The percentage of ECG gated CT scans will be determined by scans that show little to no SVC (Zone 2) fibrosis, show little to no Zone 1 fibrosis, show little to no Zone 3 fibrosis, cardiac perforation, extravascular lead location</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major complications as defined by Heart Rhythm Society (HRS) 2017 consensus guidelines</measure>
    <time_frame>30 days</time_frame>
    <description>major complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minor complications as defined by HRS 2017 consensus guidelines</measure>
    <time_frame>30 days</time_frame>
    <description>minor complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>30 days</time_frame>
    <description>Death assessed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural outcomes</measure>
    <time_frame>30 days</time_frame>
    <description>Operator ease of extraction (grade 1-5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluoroscopy time</measure>
    <time_frame>30 days</time_frame>
    <description>Fluoroscopy duration of time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pathological reports from extracted leads</measure>
    <time_frame>30 days</time_frame>
    <description>Pathology reports from extracted leads if available</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalizations directly related to the extraction of leads or procedure related</measure>
    <time_frame>30 days</time_frame>
    <description>Number of hospitalizations related to the extraction of leads or procedure related within 30 days post procedure</description>
  </secondary_outcome>
  <enrollment type="Actual">200</enrollment>
  <condition>Mechanical Complication of Cardiac Electronic Device</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Referred patients for CIED lead extraction&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Referred for CIED (Cardiac Implantable Electronic Device) lead extraction with at&#xD;
             least 1 lead with dwell time greater than one year&#xD;
&#xD;
          -  ≥ 18 years of age&#xD;
&#xD;
          -  Appropriate candidate for chest/cardiac CT with contrast and full lead analysis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Atrial fibrillation with uncontrolled rate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bruce Wilkoff, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>United Heart and Vascular Clinic</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik St. Georg</name>
      <address>
        <city>Hamburg</city>
        <zip>20099</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>November 17, 2020</last_update_submitted>
  <last_update_submitted_qc>November 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2020</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/NCT03772704
org study id: 18-1480
nct id: NCT03772704
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objectives of this registry is to correlate the amount of fibrosis as documented
      on Electrocardiogram (ECG) gated Computed Tomography (CT) scans with ease of advancing
      sheaths over the leads through the SVC zone during lead extraction.
This is a multi-center, prospective, observational registry study which plans to enroll
      approximately 200 patients referred for Cardiac Implantable Electronic Device(CIED) lead
      extraction at one of the five study centers. The objective of this study is to determine
      whether a correlation exists between fibrosis detected on ECG gated cardiac CT and the ease
      of lead extraction as measured by need for extraction energy. All patients will be followed
      for 30 days post-lead extraction to assess vital status and re-hospitalizations via phone
      call
observational model: Case-Only
time perspective: Prospective
measure: Correlation of the presence and degree of fibrosis as determined by ECG gated cardiac CT with the presence and degree of fibrosis determined by ease of extraction sheath advancement
time frame: 30 days
description: The presence and degree of fibrosis determined by the ease of extraction sheath advancement will be evaluated in three zones. Zone 1 will be the area before the Superior Vena Cava (SVC), Zone 2 in the SVC and Zone 3 after the SVC
measure: Percentage of ECG gated CT scans that show fibrosis
time frame: 30 days
description: The percentage of ECG gated CT scans will be determined by scans that show little to no SVC (Zone 2) fibrosis, show little to no Zone 1 fibrosis, show little to no Zone 3 fibrosis, cardiac perforation, extravascular lead location
measure: Major complications as defined by Heart Rhythm Society (HRS) 2017 consensus guidelines
time frame: 30 days
description: major complications
measure: Minor complications as defined by HRS 2017 consensus guidelines
time frame: 30 days
description: minor complications
measure: Mortality
time frame: 30 days
description: Death assessed
measure: Procedural outcomes
time frame: 30 days
description: Operator ease of extraction (grade 1-5)
measure: Fluoroscopy time
time frame: 30 days
description: Fluoroscopy duration of time
measure: Pathological reports from extracted leads
time frame: 30 days
description: Pathology reports from extracted leads if available
measure: Hospitalizations directly related to the extraction of leads or procedure related
time frame: 30 days
description: Number of hospitalizations related to the extraction of leads or procedure related within 30 days post procedure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bruce Wilkoff, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: United States
responsible party type: Sponsor
sharing ipd: No