<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/NCT03014180</url>
  </required_header>
  <id_info>
    <org_study_id>IPTL01</org_study_id>
    <nct_id>NCT03014180</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm (LEVEA)</brief_title>
  <acronym>LEVEA</acronym>
  <official_title>Clinical Evaluation of LEft VEntricular Auto Threshold Algorithm</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LivaNova</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LivaNova</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 purpose of the LEVEA study is to assess the performances of a new automatic left&#xD;
      ventricular auto threshold (LVAT) algorithm (In-Clinic LVAT algorithm) when used by&#xD;
      physicians during in-hospital follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      &quot;In-Clinic LVAT&quot; feature is a non CE-marked feature designed to be activated by the physician&#xD;
      during 2 hospital follow-ups:&#xD;
&#xD;
        -  first visit: planned to be conducted 15 days maximum after inclusion&#xD;
&#xD;
        -  second visit: planned to be conducted between 1 and 3 months after the first visit The&#xD;
           evaluation consists in the comparison between the threshold value provided by the&#xD;
           algorithm and the threshold value obtained manually by the physician.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 16, 2017</start_date>
  <completion_date type="Actual">August 17, 2017</completion_date>
  <primary_completion_date type="Actual">August 17, 2017</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>Percentage of Successful&quot;In-Clinic LVAT&quot; Test</measure>
    <time_frame>0-3 months post inclusion</time_frame>
    <description>The success rate is defined as the equivalence between the value measured by the algorithm and the measure obtained manually by the physician on 5 identified pacing vectors during the visit among at least 231 LV tests.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Accurate &quot;In-Clinic LVAT&quot; Test Assessed by an Independent Reviewer</measure>
    <time_frame>0-15 days post inclusion</time_frame>
    <description>This endpoint is the number of accurate determination of the pacing threshold value provided by the algorithm feature and an independent reviewer, on all available LV pacing vectors at first visit.&#xD;
An independent reviewer assessed all LV pacing threshold values provided by the algorithm at M0 visit and in all tested configurations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Successful of &quot;In-Clinic LVAT&quot; Test at M0 Visit</measure>
    <time_frame>0-15 days post inclusion</time_frame>
    <description>The success rate of &quot;In-Clinic LVAT&quot; feature for all available LV pacing vectors at first follow-up (M0 visit). The method of analysis is similar to the primary endpoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Successful &quot;In-Clinic LVAT&quot; Test at M1 Visit</measure>
    <time_frame>1-3 months after first visit</time_frame>
    <description>The success rate of &quot;In-Clinic LVAT&quot; feature for all available LV pacing vectors at second follow-up . The method of analysis is similar to the primary endpoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Eligible Subjects to LVAT Feature</measure>
    <time_frame>0-3 months post inclusion</time_frame>
    <description>Identification of the number of subjects who were &quot;eligible&quot; to receive the feature at M0 or M1 visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of the LVAT Algorithm</measure>
    <time_frame>0-3 months post inclusion</time_frame>
    <description>Reporting of SAEs, device deficiencies and any suspect behaviour of the algorithm.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>&quot;In-Clinic LVAT&quot;</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subject prior to study enrollment has been implanted with a CRT-D device. During follow-ups, under the supervision of the physician, the algorithm embeded in the device is activated with a password. The feature is deactivated at the end of each follow-up.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>&quot;In-Clinic LVAT&quot;</intervention_name>
    <description>Algorithm offers automatic threshold measurement of differents vectors of left ventricular stimulation.</description>
    <arm_group_label>&quot;In-Clinic LVAT&quot;</arm_group_label>
    <other_name>Activation of an algorithm in CRT-D device</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject already implanted (de-novo, upgrade or replacement) according to the relevant&#xD;
             ESC Guidelines [1]:&#xD;
&#xD;
               -  With IS1 Platinium SonR CRT-D (models 1811, 1841, CE-marked) for maximum of 5&#xD;
                  days or;&#xD;
&#xD;
               -  With IS4 Platinium SonR CRT-D (model 1844, CE-marked).&#xD;
&#xD;
          -  Right atrial, right and left ventricular leads must be implanted. Only bipolar and&#xD;
             quadripolar for Left Ventricular lead.&#xD;
&#xD;
          -  Reviewed, signed and dated informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject included in another clinical study that could confound the results of this&#xD;
             study;&#xD;
&#xD;
          -  Malfunction or dislodgment of right atrial, right and left ventricular implanted&#xD;
             leads;&#xD;
&#xD;
          -  Subject diagnosed with permanent atrial fibrillation;&#xD;
&#xD;
          -  Known pregnancy;&#xD;
&#xD;
          -  Minor age;&#xD;
&#xD;
          -  Under protection or guardianship;&#xD;
&#xD;
          -  Unavailability for scheduled follow-up or refusal to cooperate&#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>Jacques Mansourati, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHRU de Brest, FRANCE.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHRU Brest</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>October 11, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <results_first_submitted>September 20, 2018</results_first_submitted>
  <results_first_submitted_qc>February 13, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">May 28, 2019</results_first_posted>
  <last_update_submitted>February 13, 2019</last_update_submitted>
  <last_update_submitted_qc>February 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Heart failure, CRT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 29, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT03014180/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 20, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/80/NCT03014180/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects have been included from Feb 16, 2017 to June 2, 2017.</recruitment_details>
      <pre_assignment_details>All the 60 patients were assigned to the treatment arm.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>&quot;In-Clinic LVAT&quot;</title>
          <description>60 patients were included in the single-arm study. The Left Ventricular auto threshold (LVAT) algorithm test was performed at the 2 study visits M0 and M1.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>&quot;In-Clinic LVAT&quot;</title>
          <description>Single-arm study design: all the 60 patients were assigned to the treatment arm.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68.4" spread="8.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type of device implanted</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>IS1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IS4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Successful&quot;In-Clinic LVAT&quot; Test</title>
        <description>The success rate is defined as the equivalence between the value measured by the algorithm and the measure obtained manually by the physician on 5 identified pacing vectors during the visit among at least 231 LV tests.</description>
        <time_frame>0-3 months post inclusion</time_frame>
        <population>Complete LV vector test: test was performed (not aborted or interrupted) and a threshold value is provided by the algorithm.&#xD;
Successful LV Vector Test: LV threshold value provided by the algorithm compared to the manual threshold is considered &quot;Successful&quot; if the difference is within ± 2 step</population>
        <group_list>
          <group group_id="O1">
            <title>In-clinic LVAT</title>
            <description>Patients assigned to the single-arm treatment LVAT. LVAT test performed at M0 and M1 visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Successful&quot;In-Clinic LVAT&quot; Test</title>
          <description>The success rate is defined as the equivalence between the value measured by the algorithm and the measure obtained manually by the physician on 5 identified pacing vectors during the visit among at least 231 LV tests.</description>
          <population>Complete LV vector test: test was performed (not aborted or interrupted) and a threshold value is provided by the algorithm.&#xD;
Successful LV Vector Test: LV threshold value provided by the algorithm compared to the manual threshold is considered &quot;Successful&quot; if the difference is within ± 2 step</population>
          <units>percentage of successful LVAT test</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Completed LV vector tests</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Completed LV vector tests</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="262"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.66" lower_limit="90.66" upper_limit="97.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Accurate &quot;In-Clinic LVAT&quot; Test Assessed by an Independent Reviewer</title>
        <description>This endpoint is the number of accurate determination of the pacing threshold value provided by the algorithm feature and an independent reviewer, on all available LV pacing vectors at first visit.&#xD;
An independent reviewer assessed all LV pacing threshold values provided by the algorithm at M0 visit and in all tested configurations</description>
        <time_frame>0-15 days post inclusion</time_frame>
        <population>Completed LV Vector Test: test was performed (not aborted or interrupted) and a threshold value is provided by the algorithm.&#xD;
Accurate LV Vector Test: The LV threshold value provided by the algorithm compared to the reviewer assessment is considered accurate if the difference is within ± 1 step.</population>
        <group_list>
          <group group_id="O1">
            <title>In-clinic LVAT</title>
            <description>Patients assigned to the single-arm treatment LVAT. LVAT test performed at M0 visit.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Accurate &quot;In-Clinic LVAT&quot; Test Assessed by an Independent Reviewer</title>
          <description>This endpoint is the number of accurate determination of the pacing threshold value provided by the algorithm feature and an independent reviewer, on all available LV pacing vectors at first visit.&#xD;
An independent reviewer assessed all LV pacing threshold values provided by the algorithm at M0 visit and in all tested configurations</description>
          <population>Completed LV Vector Test: test was performed (not aborted or interrupted) and a threshold value is provided by the algorithm.&#xD;
Accurate LV Vector Test: The LV threshold value provided by the algorithm compared to the reviewer assessment is considered accurate if the difference is within ± 1 step.</population>
          <units>Percentage of accurate determination</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Number of completed LV Vector Tests</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Number of completed LV Vector Tests</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1301"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.31" lower_limit="98.59" upper_limit="99.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Successful of &quot;In-Clinic LVAT&quot; Test at M0 Visit</title>
        <description>The success rate of &quot;In-Clinic LVAT&quot; feature for all available LV pacing vectors at first follow-up (M0 visit). The method of analysis is similar to the primary endpoint.</description>
        <time_frame>0-15 days post inclusion</time_frame>
        <population>Completed LV vector Test: test was performed (not aborted or interrupted) and a threshold value is provided by the algorithm.&#xD;
Successful LV Vector Test: LV threshold value provided by the algorithm compared to the manual threshold is considered &quot;Successful&quot; if the difference is within ± 2 steps</population>
        <group_list>
          <group group_id="O1">
            <title>In-clinic LVAT</title>
            <description>Patients assigned to the single-arm treatment LVAT at M0 visit.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Successful of &quot;In-Clinic LVAT&quot; Test at M0 Visit</title>
          <description>The success rate of &quot;In-Clinic LVAT&quot; feature for all available LV pacing vectors at first follow-up (M0 visit). The method of analysis is similar to the primary endpoint.</description>
          <population>Completed LV vector Test: test was performed (not aborted or interrupted) and a threshold value is provided by the algorithm.&#xD;
Successful LV Vector Test: LV threshold value provided by the algorithm compared to the manual threshold is considered &quot;Successful&quot; if the difference is within ± 2 steps</population>
          <units>Percentage of successful LVAT test</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Number of completed LV Vector Tests</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Number of completed LV Vector Tests</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1193"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.86" lower_limit="88.82" upper_limit="92.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Successful &quot;In-Clinic LVAT&quot; Test at M1 Visit</title>
        <description>The success rate of &quot;In-Clinic LVAT&quot; feature for all available LV pacing vectors at second follow-up . The method of analysis is similar to the primary endpoint</description>
        <time_frame>1-3 months after first visit</time_frame>
        <population>Completed LV Vector Test: test was performed (not aborted or interrupted) and a threshold value is provided by the algorithm.&#xD;
Successful LV Vector Test: LV threshold value provided by the algorithm compared to the manual threshold is considered &quot;Successful&quot; if the difference is within ± 2 steps</population>
        <group_list>
          <group group_id="O1">
            <title>In-clinic LVAT</title>
            <description>Patients assigned to the single-arm treatment LVAT at M1 visit.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Successful &quot;In-Clinic LVAT&quot; Test at M1 Visit</title>
          <description>The success rate of &quot;In-Clinic LVAT&quot; feature for all available LV pacing vectors at second follow-up . The method of analysis is similar to the primary endpoint</description>
          <population>Completed LV Vector Test: test was performed (not aborted or interrupted) and a threshold value is provided by the algorithm.&#xD;
Successful LV Vector Test: LV threshold value provided by the algorithm compared to the manual threshold is considered &quot;Successful&quot; if the difference is within ± 2 steps</population>
          <units>Pecentage of successful LVAT test</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Number of completed LV Vector Tests</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Number of completed LV Vector Tests</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.03" lower_limit="90.12" upper_limit="93.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Eligible Subjects to LVAT Feature</title>
        <description>Identification of the number of subjects who were &quot;eligible&quot; to receive the feature at M0 or M1 visit</description>
        <time_frame>0-3 months post inclusion</time_frame>
        <population>Eligible subjects: Number of subjects with at least one complete LV Vector Test at M0 or M1 visits</population>
        <group_list>
          <group group_id="O1">
            <title>In-clinic LVAT</title>
            <description>Patients assigned to the single-arm treatment LVAT. LVAT test performed at M0 and M1 visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Eligible Subjects to LVAT Feature</title>
          <description>Identification of the number of subjects who were &quot;eligible&quot; to receive the feature at M0 or M1 visit</description>
          <population>Eligible subjects: Number of subjects with at least one complete LV Vector Test at M0 or M1 visits</population>
          <units>Percentage of eligible subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety of the LVAT Algorithm</title>
        <description>Reporting of SAEs, device deficiencies and any suspect behaviour of the algorithm.</description>
        <time_frame>0-3 months post inclusion</time_frame>
        <population>Included population</population>
        <group_list>
          <group group_id="O1">
            <title>Secondary Endpoint</title>
            <description>All serious adverse events and device deficiency during in-clinic LVAT test.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety of the LVAT Algorithm</title>
          <description>Reporting of SAEs, device deficiencies and any suspect behaviour of the algorithm.</description>
          <population>Included population</population>
          <units>Event</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>0-3 months post inclusion</time_frame>
      <desc>SAE and device deficiency were collected through the study duration and AE was collected at each study visit.</desc>
      <group_list>
        <group group_id="E1">
          <title>In-Clinic LVAT</title>
          <description>All serious adverse events and device deficiency during in-clinic LVAT test.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac decompensation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>Heart failure worsening</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Bleeding</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Embolization</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Director of Scientific Communication</name_or_title>
      <organization>Microport CRM</organization>
      <phone>0677164209</phone>
      <email>anne.rousseauplasse@crm.microport.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03014180
org study id: IPTL01
nct id: NCT03014180
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the LEVEA study is to assess the performances of a new automatic left
      ventricular auto threshold (LVAT) algorithm (In-Clinic LVAT algorithm) when used by
      physicians during in-hospital follow-up.
"In-Clinic LVAT" feature is a non CE-marked feature designed to be activated by the physician
      during 2 hospital follow-ups:

        -  first visit: planned to be conducted 15 days maximum after inclusion

        -  second visit: planned to be conducted between 1 and 3 months after the first visit The
           evaluation consists in the comparison between the threshold value provided by the
           algorithm and the threshold value obtained manually by the physician.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Successful"In-Clinic LVAT" Test
time frame: 0-3 months post inclusion
description: The success rate is defined as the equivalence between the value measured by the algorithm and the measure obtained manually by the physician on 5 identified pacing vectors during the visit among at least 231 LV tests.
measure: Percentage of Accurate "In-Clinic LVAT" Test Assessed by an Independent Reviewer
time frame: 0-15 days post inclusion
description: This endpoint is the number of accurate determination of the pacing threshold value provided by the algorithm feature and an independent reviewer, on all available LV pacing vectors at first visit.
An independent reviewer assessed all LV pacing threshold values provided by the algorithm at M0 visit and in all tested configurations
measure: Percentage of Successful of "In-Clinic LVAT" Test at M0 Visit
time frame: 0-15 days post inclusion
description: The success rate of "In-Clinic LVAT" feature for all available LV pacing vectors at first follow-up (M0 visit). The method of analysis is similar to the primary endpoint.
measure: Percentage of Successful "In-Clinic LVAT" Test at M1 Visit
time frame: 1-3 months after first visit
description: The success rate of "In-Clinic LVAT" feature for all available LV pacing vectors at second follow-up . The method of analysis is similar to the primary endpoint
measure: Percentage of Eligible Subjects to LVAT Feature
time frame: 0-3 months post inclusion
description: Identification of the number of subjects who were "eligible" to receive the feature at M0 or M1 visit
measure: Safety of the LVAT Algorithm
time frame: 0-3 months post inclusion
description: Reporting of SAEs, device deficiencies and any suspect behaviour of the algorithm.
arm group label: "In-Clinic LVAT"
arm group type: Experimental
description: All subject prior to study enrollment has been implanted with a CRT-D device. During follow-ups, under the supervision of the physician, the algorithm embeded in the device is activated with a password. The feature is deactivated at the end of each follow-up.
intervention type: Device
intervention name: "In-Clinic LVAT"
description: Algorithm offers automatic threshold measurement of differents vectors of left ventricular stimulation.
arm group label: "In-Clinic LVAT"
other name: Activation of an algorithm in CRT-D device
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jacques Mansourati, Pr
role: Principal Investigator
affiliation: CHRU de Brest, FRANCE.
facility: 
country: France
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 