<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/NCT01685047</url>
  </required_header>
  <id_info>
    <org_study_id>CR-12-014-ID-HV</org_study_id>
    <nct_id>NCT01685047</nct_id>
  </id_info>
  <brief_title>A Clinical Evaluation of ST Changes in a Group of Patients Having Ventricular Arrhythmias</brief_title>
  <acronym>inSighT</acronym>
  <official_title>A Clinical Evaluation of ST Changes in a Group of Patients Having Ventricular Arrhythmias</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Devices</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this investigation is to determine the prevalence of device-recorded ST&#xD;
      segment changes occurring before appropriate Implantable Cardiac Defibrillator (ICD)&#xD;
      therapies (ATP or Shock) and to define their temporal relationship to ventricular&#xD;
      arrhythmias.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sudden cardiac death due to cardiac arrhythmia is a devastating and unpredictable&#xD;
      complication of coronary artery disease.&#xD;
&#xD;
      Implantation of automatic implantable cardioverter defibrillators (ICD) is a well established&#xD;
      therapy for the treatment and prevention of sudden cardiac death. Evidence for the use of&#xD;
      these devices has been provided by a number of landmark clinical trials over the last 16&#xD;
      years.&#xD;
&#xD;
      Reduction in ischemia can be achieved by coronary artery revascularization but in many&#xD;
      patients may occur a gradual progression to recurrence of ischemia resulting in further life&#xD;
      threatening arrhythmias. It is reasonable to assume that unchecked progression of ischemic&#xD;
      heart disease may result in increased mortality in ICD patients. It has been shown that the&#xD;
      long term mortality risk for ICD patients can be linked to the time since the last coronary&#xD;
      revascularization procedure. Both MADIT-II and Sudden Cardiac Death in Heart Failure trial&#xD;
      (SCD-HeFT) showed that patients receiving inappropriate ICD therapy have an increased risk of&#xD;
      death. It has been speculated that this may be due to progression of the disease and&#xD;
      recurrent ischemia.&#xD;
&#xD;
      A feature available in some ICDs manufactured by St Jude medical enables the constant beat to&#xD;
      beat monitoring of the intra-cardiac ST segment using the implanted ICD leads. Similar&#xD;
      systems have demonstrated this approach to be a reliable method of identifying ischemic&#xD;
      events. However, the predictive value of the ST monitoring feature in identifying pending&#xD;
      arrhythmic events has yet to be established. Prediction of worsening ischemia could play an&#xD;
      important part in allowing physicians to identify ICD patients with greater mortality risk&#xD;
      and allow them the time to personalize patient therapy in order to reduce that risk.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Among Patients With an Appropriate ICD Therapy (Shock or ATP) for Ventricular Tachycardia or Fibrillation, the Number of Patients Who Have Characterized ST Segment Changes From Baseline Prior to the Therapy Was Calculated.</measure>
    <time_frame>Until the end of follow up period</time_frame>
  </primary_outcome>
  <enrollment type="Actual">481</enrollment>
  <condition>Coronary Artery Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient is implanted with SJM ICD and has or is at high risk of CAD&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient is implanted with an St Jude Medical (SJM) ICD with ST Monitoring and&#xD;
             ShockGuard™ features (and remote care feature in case Merlin.net will be used)&#xD;
&#xD;
          -  The patient, in the opinion of the investigator, will not require ventricular pacing&#xD;
             for more than 20% of the time.&#xD;
&#xD;
          -  The patient, in the opinion of the investigator, has or is at high risk of Coronary&#xD;
             Artery Disease (CAD).&#xD;
&#xD;
          -  The patient is ≥ 18 years of age.&#xD;
&#xD;
          -  The patient is able to provide written Informed Consent prior to any investigational&#xD;
             related procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient has longstanding persistent Atrial Fibrillation (AF) /Atrial Flutter (AFl)&#xD;
             or permanent AF/AFl&#xD;
&#xD;
          -  The patient has documented complete heart block.&#xD;
&#xD;
          -  The patient is known to have uncontrolled ventricular bigeminy or trigeminy (PVCs on&#xD;
             regular basis).&#xD;
&#xD;
          -  The patient has severe Left Ventricular Hypertrophy resulting in interventricular&#xD;
             conduction defect (IVCD).&#xD;
&#xD;
          -  The patient has intermittent bundle branch blocks (BBB).&#xD;
&#xD;
          -  The patient is unable to comply with the follow up schedule.&#xD;
&#xD;
          -  The patient is participating in another investigational device or drug investigation.&#xD;
&#xD;
          -  The patient is pregnant or is planning to become pregnant during the duration of the&#xD;
             investigation.&#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>Johannes SPERZEL, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kerckhoff Klinik, Bad Nauheim Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kerckhoff Klinik</name>
      <address>
        <city>Bad Nauheim</city>
        <zip>D-61231</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <results_first_submitted>February 17, 2017</results_first_submitted>
  <results_first_submitted_qc>January 21, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 25, 2019</results_first_posted>
  <last_update_submitted>July 24, 2019</last_update_submitted>
  <last_update_submitted_qc>July 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronary Artery Disease</keyword>
  <keyword>Ventricular Arrhythmias</keyword>
  <keyword>ST Segment Changes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Patient Population</title>
          <description>Patients implanted with a St. Jude Medical ICD device with ST monitoring and ShockGuard feature, a right ventricular lead and, when applicable, a right atrial lead, were eligible for this investigation.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="481">481 subjects signed the consent. 1 subject was withdrawn prior to the baseline visit.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="396"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="85"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>patient withdrawn by sponsor</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>A total of 481 subjects were enrolled. However, 1 subject was withdrawn immediately after enrollment because this subject was not implanted with the study required device. Therefore, the total number of baseline participants (480) is discrepant to the number of participants started (481).</population>
      <group_list>
        <group group_id="B1">
          <title>Patient Population</title>
          <description>Patients implanted with a St. Jude Medical ICD device with ST monitoring and ShockGuard feature, a right ventricular lead and, when applicable, a right atrial lead, were eligible for this investigation.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="480"/>
          </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="63.95" spread="11.29"/>
                  </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="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="400"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Indication for Implant</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Primary prevention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="296"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Secondary prevention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="184"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Medical History</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Arrhythmogenic RV cardiomyopathy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetic cardiomyopathy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dilated cardiomyopathy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypertrophic cardiomyopathy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inschemic cardiomyopathy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="366"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non Ischemic cardiomyopathy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Obesity associated cardiomyopathy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Atrial Arrhythmia history</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Atrial Fibrillation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Atrial Flutter</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ventricular Arrhythmia history</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Premature ventricular contractions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monomorphic ventricular tachycardia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ventricular fibrillation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polymorphic ventricular tachycardia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Among Patients With an Appropriate ICD Therapy (Shock or ATP) for Ventricular Tachycardia or Fibrillation, the Number of Patients Who Have Characterized ST Segment Changes From Baseline Prior to the Therapy Was Calculated.</title>
        <time_frame>Until the end of follow up period</time_frame>
        <population>The other subjects enrolled in this study had no treated VT/VF events.</population>
        <group_list>
          <group group_id="O1">
            <title>Patient Population</title>
            <description>Patients implanted with a St. Jude Medical ICD device with ST monitoring and ShockGuard feature, a right ventricular lead and, when applicable, a right atrial lead, were eligible for this investigation.</description>
          </group>
        </group_list>
        <measure>
          <title>Among Patients With an Appropriate ICD Therapy (Shock or ATP) for Ventricular Tachycardia or Fibrillation, the Number of Patients Who Have Characterized ST Segment Changes From Baseline Prior to the Therapy Was Calculated.</title>
          <population>The other subjects enrolled in this study had no treated VT/VF events.</population>
          <units>participants</units>
          <param>Number</param>
          <units_analyzed>VT/VF events</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="117"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>VT/VF events</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>There were no formal pre-specified statistical hypotheses for the endpoints of the study due to the exploratory nature of this study. Some data was excluded from the primary analysis. All device detections resulting in therapy have been reviewed for appropriateness of the therapy. VT/VF therapy delivered from the device as a result of a non-ventricular arrhythmia or as a result of oversensing by the device has not been included in the primary data analysis.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>There were no formal pre-specified statistical hypotheses for the endpoints of the study due to the exploratory nature of this study. Datasets (Device info at Baseline versus 15 minutes prior to the event) were compared using a 2-sided t-test.</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <p_value_desc>All events with p &lt;0.05 were visually inspected to confirm they were evaluable; additional criteria for exclusion from further analysis included inappropriate therapy, aberrant conduction, and occurrence of VT/VF within 24h prior to the event.</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Safety surveillance and reporting started as soon as the subject was enrolled until study conclusion. All patients were followed up until the last patient had performed his/her 12 month follow up visit, therefore, no fixed period is available per patient. The study (and follow up period) ended for all patients 26AUG2016.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Patient Population</title>
          <description>Patients implanted with a St. Jude Medical ICD device with ST monitoring and ShockGuard feature, a right ventricular lead and, when applicable, a right atrial lead, were eligible for this investigation.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="147" subjects_at_risk="481"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Thromboemboli</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="481"/>
              </event>
              <event>
                <sub_title>Transient Ischemic Attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="481"/>
              </event>
              <event>
                <sub_title>Veinthrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="481"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" events="37" subjects_affected="29" subjects_at_risk="481"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="481"/>
              </event>
              <event>
                <sub_title>Death - Cardiovascular related</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="481"/>
              </event>
              <event>
                <sub_title>Exacerbation of Heart failure</sub_title>
                <counts group_id="E1" events="33" subjects_affected="23" subjects_at_risk="481"/>
              </event>
              <event>
                <sub_title>Ischemic Cardiomyopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="481"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="481"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastro-enteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="481"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death - Non cardiovascular related</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="481"/>
              </event>
              <event>
                <sub_title>Death - Unknown</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="481"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection related to system and/or procedure</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="481"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Component failure</sub_title>
                <description>Device component failure</description>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="481"/>
              </event>
              <event>
                <sub_title>Drug Reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="481"/>
              </event>
              <event>
                <sub_title>Inappropriate high voltage therapy</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="481"/>
              </event>
              <event>
                <sub_title>Lead dislodgement or migration</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="481"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Renal Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="481"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="481"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Inappropriate device function</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="481"/>
              </event>
              <event>
                <sub_title>Other non cardiovascular</sub_title>
                <counts group_id="E1" events="71" subjects_affected="61" subjects_at_risk="481"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Other cardiovascular related event</sub_title>
                <counts group_id="E1" events="35" subjects_affected="30" subjects_at_risk="481"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="57" subjects_at_risk="481"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="481"/>
              </event>
              <event>
                <sub_title>Vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="481"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" events="15" subjects_affected="12" subjects_at_risk="481"/>
              </event>
              <event>
                <sub_title>Exacerbation of heart failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="481"/>
              </event>
              <event>
                <sub_title>Other cardiovascular</sub_title>
                <counts group_id="E1" events="13" subjects_affected="11" subjects_at_risk="481"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Other non cardiovascular</sub_title>
                <counts group_id="E1" events="15" subjects_affected="14" subjects_at_risk="481"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Inappropriate High Voltage therapy</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="481"/>
              </event>
              <event>
                <sub_title>Inappropriate low voltage therapy</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="481"/>
              </event>
              <event>
                <sub_title>Lead dislodgement or migration</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="481"/>
              </event>
              <event>
                <sub_title>device oversensing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="481"/>
              </event>
              <event>
                <sub_title>Device threshold elevation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="481"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>pleural effusion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="481"/>
              </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>
    <limitations_and_caveats>Additional investigation into ST segment changes in advance of VT/VF, including their association to confirmed ischemic events, is warranted.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Karolien Timmermans</name_or_title>
      <organization>St Jude Medical</organization>
      <phone>0032 497 51 39 21</phone>
      <email>ktimmermans@sjm.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/NCT01685047
org study id: CR-12-014-ID-HV
nct id: NCT01685047
lead sponsor: 
has dmc: No
The purpose of this investigation is to determine the prevalence of device-recorded ST
      segment changes occurring before appropriate Implantable Cardiac Defibrillator (ICD)
      therapies (ATP or Shock) and to define their temporal relationship to ventricular
      arrhythmias.
Sudden cardiac death due to cardiac arrhythmia is a devastating and unpredictable
      complication of coronary artery disease.

      Implantation of automatic implantable cardioverter defibrillators (ICD) is a well established
      therapy for the treatment and prevention of sudden cardiac death. Evidence for the use of
      these devices has been provided by a number of landmark clinical trials over the last 16
      years.

      Reduction in ischemia can be achieved by coronary artery revascularization but in many
      patients may occur a gradual progression to recurrence of ischemia resulting in further life
      threatening arrhythmias. It is reasonable to assume that unchecked progression of ischemic
      heart disease may result in increased mortality in ICD patients. It has been shown that the
      long term mortality risk for ICD patients can be linked to the time since the last coronary
      revascularization procedure. Both MADIT-II and Sudden Cardiac Death in Heart Failure trial
      (SCD-HeFT) showed that patients receiving inappropriate ICD therapy have an increased risk of
      death. It has been speculated that this may be due to progression of the disease and
      recurrent ischemia.

      A feature available in some ICDs manufactured by St Jude medical enables the constant beat to
      beat monitoring of the intra-cardiac ST segment using the implanted ICD leads. Similar
      systems have demonstrated this approach to be a reliable method of identifying ischemic
      events. However, the predictive value of the ST monitoring feature in identifying pending
      arrhythmic events has yet to be established. Prediction of worsening ischemia could play an
      important part in allowing physicians to identify ICD patients with greater mortality risk
      and allow them the time to personalize patient therapy in order to reduce that risk.
observational model: Cohort
time perspective: Prospective
measure: Among Patients With an Appropriate ICD Therapy (Shock or ATP) for Ventricular Tachycardia or Fibrillation, the Number of Patients Who Have Characterized ST Segment Changes From Baseline Prior to the Therapy Was Calculated.
time frame: Until the end of follow up period
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Johannes SPERZEL, MD
role: Principal Investigator
affiliation: Kerckhoff Klinik, Bad Nauheim Germany
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Arrhythmias, Cardiac
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Additional investigation into ST segment changes in advance of VT/VF, including their association to confirmed ischemic events, is warranted.
point of contact: 