<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/NCT01714921</url>
  </required_header>
  <id_info>
    <org_study_id>CEN_G_CA_13</org_study_id>
    <nct_id>NCT01714921</nct_id>
  </id_info>
  <brief_title>Protecta Smart Analysis Register</brief_title>
  <acronym>ProSA</acronym>
  <official_title>ProSA Protecta Smart Analysis Register</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Bakken Research Center</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic GmbH Germany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medtronic Bakken Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      ProSA is a prospective, non-randomized, multicenter, observational study investigating the&#xD;
      utilization and effectiveness of the Smart Shock™ algorithm in ICD patients treated with a&#xD;
      Protecta™, Protecta™ XT or any equivalent following product.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 9, 2010</start_date>
  <completion_date type="Actual">January 5, 2015</completion_date>
  <primary_completion_date type="Actual">January 5, 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>24 Months</target_duration>
  <primary_outcome>
    <measure>Analysis of Change of Episodes Inappropriately Treated by Shock Therapy Due to Smart Shock™ Technology.</measure>
    <time_frame>24 months</time_frame>
    <description>Smart Shock technology is a suite of algorithms that are designed to prevent inappropriate shocks in ICD&amp;CRT patients.&#xD;
Endpoints for the primary objective:&#xD;
Episodes with shock therapy&#xD;
Episodes without shock delivery due to Smart Shock™ technology&#xD;
Episodes classified as supraventricular tachycardia (SVT) by PR Logic&#xD;
Episodes classified as SVT by Wavelet&#xD;
Shock therapy suppressed by T-wave Discrimination&#xD;
Shock therapy suppressed by Lead Noise Discrimination&#xD;
Shock therapy suppressed by Confirmation +&#xD;
Episode with successful anti-tachycardia pacing (ATP) During Charging</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With All Smart Shock Algorithms Are Programmed on</measure>
    <time_frame>90 days or 180 days</time_frame>
    <description>Endpoint: Patients, in which none of the Smart Shock algorithms is programmed &quot;OFF&quot; during the first Follow-Up after a maximum length of 90 days and 180 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients, Without Shock Delivery Due to Smart Shock Technology</measure>
    <time_frame>24 months</time_frame>
    <description>Endpoint: Patients without shock delivery due to Smart Shock technology</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of the Number of Patients With Primary Preventive Indication for an ICD That Develop VF Episodes.</measure>
    <time_frame>24 months</time_frame>
    <description>Endpoint: Number of primary prevention patients with at least one ventricular fibrillation (VF) episode detected and successfully treated by the ICD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients That Developed AT/AF</measure>
    <time_frame>24 months</time_frame>
    <description>Endpoint: patients with &gt;5 min atrial tachycardia/atrial fibrillation (AT/AF) in 'Daily Log' (Cardiac Compass)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of the Proportion of Patients in Which ICD Parameters Remain on Nominal Programming.</measure>
    <time_frame>At the first Follow-Up ≥ 90 days post-implant</time_frame>
    <description>Endpoint: Deviation of ICD parameter programming in comparison to nominal programming at the first Follow-Up ≥ 90 days post-implant.&#xD;
Nominals for dual chamber ICD or cardiac resynchronization therapy (CRT) devices:&#xD;
Lead Noise Discrimination = 'OnWithTimeout'&#xD;
Lead Failure Predictor = 'On'&#xD;
PR-Logic: AfibAflutter Rejection Rule = 'On'&#xD;
PR-Logic: Sinus Tach Rejection Rule = 'On'&#xD;
PR-Logic: Other 1:1 Rejection Rule = 'On'&#xD;
High Rate Timeout = 'Off'&#xD;
VF High Rate Timeout = 'Off'&#xD;
Wavelet Rejection Rule = 'On'&#xD;
VF Detection Interval = 320 and SVT Minimum Cycle Length = 260&#xD;
T-Wave Oversensing Discrimination = 'On'&#xD;
ATP During Charging = 'DuringCharging'&#xD;
Nominals for single chamber ICDs:&#xD;
Lead Noise Discrimination = 'OnWithTimeout'&#xD;
Lead Failure Predictor = 'On'&#xD;
High Rate Timeout = 'Off'&#xD;
VF High Rate Timeout = '0.75 min'&#xD;
Wavelet Rejection Rule = 'On'&#xD;
VF Detection Interval = 320 and SVT Minimum Cycle Length = 260&#xD;
T-Wave Oversensing D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of the Positive Predictive Value of the Investigated ICD Oversensing Algorithms</measure>
    <time_frame>through study completion</time_frame>
    <description>Endpoint: Episode classified by the device as T-wave Oversensing or 'Noise'.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">504</enrollment>
  <condition>Patients With an Indication for an ICD Implantation According to the Guidelines</condition>
  <arm_group>
    <arm_group_label>ICD patients</arm_group_label>
    <description>Patients with an indication for an ICD implantation according to the guidelines treated with a Protecta™, Protecta™ XT or any equivalent following product</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients that satisfy the inclusion criteria and signed the informed consent&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients implanted with an Implantable Cardioverter Defibrillator (ICD) with the smart&#xD;
             shock algorithm (Protecta™, Protecta™ XT or any equivalent following product)&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with life expectancy less than 24 months&#xD;
&#xD;
          -  patients younger than 18 years&#xD;
&#xD;
          -  pregnant or breast feeding women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <results_first_submitted>September 5, 2017</results_first_submitted>
  <results_first_submitted_qc>April 17, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">November 13, 2018</results_first_posted>
  <last_update_submitted>April 17, 2018</last_update_submitted>
  <last_update_submitted_qc>April 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>

  <clinical_results>

    <participant_flow>
      <recruitment_details>504 patients were enrolled at 29 German sites between 09-Jun-2010 and 22-Oct-2012</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>ICD Patients (Single Arm Study)</title>
          <description>Patients with an indication for an Implantable Cardioverter/Defibrillator (ICD) implantation according to the guidelines treated with a Protecta™, Protecta™ XT or any equivalent following product</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="504"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="311"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="193"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>ICD Patients</title>
          <description>Patients with an indication for an ICD implantation according to the guidelines treated with a Protecta™, Protecta™ XT or any equivalent following product</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="504"/>
          </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="65.5" spread="12.4"/>
                  </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="NA">data has been gathered based on information stored in the device. Data on sex is not available in this data.</measurement>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="NA">Data were not collected</measurement>
                  </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>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="504"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Analysis of Change of Episodes Inappropriately Treated by Shock Therapy Due to Smart Shock™ Technology.</title>
        <description>Smart Shock technology is a suite of algorithms that are designed to prevent inappropriate shocks in ICD&amp;CRT patients.&#xD;
Endpoints for the primary objective:&#xD;
Episodes with shock therapy&#xD;
Episodes without shock delivery due to Smart Shock™ technology&#xD;
Episodes classified as supraventricular tachycardia (SVT) by PR Logic&#xD;
Episodes classified as SVT by Wavelet&#xD;
Shock therapy suppressed by T-wave Discrimination&#xD;
Shock therapy suppressed by Lead Noise Discrimination&#xD;
Shock therapy suppressed by Confirmation +&#xD;
Episode with successful anti-tachycardia pacing (ATP) During Charging</description>
        <time_frame>24 months</time_frame>
        <population>The change of episodes of episodes inappropriately treated by shock due to Smart Shock™ was calculated as follow:&#xD;
change of episodes= (Episodes without shock therapy due to Smart Shock™)/(total number of episodes)</population>
        <group_list>
          <group group_id="O1">
            <title>ICD Patients (Single Arm Study)</title>
            <description>Patients with an indication for an ICD implantation according to the guidelines treated with a Protecta™, Protecta™ XT or any equivalent following product</description>
          </group>
        </group_list>
        <measure>
          <title>Analysis of Change of Episodes Inappropriately Treated by Shock Therapy Due to Smart Shock™ Technology.</title>
          <description>Smart Shock technology is a suite of algorithms that are designed to prevent inappropriate shocks in ICD&amp;CRT patients.&#xD;
Endpoints for the primary objective:&#xD;
Episodes with shock therapy&#xD;
Episodes without shock delivery due to Smart Shock™ technology&#xD;
Episodes classified as supraventricular tachycardia (SVT) by PR Logic&#xD;
Episodes classified as SVT by Wavelet&#xD;
Shock therapy suppressed by T-wave Discrimination&#xD;
Shock therapy suppressed by Lead Noise Discrimination&#xD;
Shock therapy suppressed by Confirmation +&#xD;
Episode with successful anti-tachycardia pacing (ATP) During Charging</description>
          <population>The change of episodes of episodes inappropriately treated by shock due to Smart Shock™ was calculated as follow:&#xD;
change of episodes= (Episodes without shock therapy due to Smart Shock™)/(total number of episodes)</population>
          <units>% of episodes wo shock due to SmartShock</units>
          <param>Number</param>
          <units_analyzed>total number of episodes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="504"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>total number of episodes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2529"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With All Smart Shock Algorithms Are Programmed on</title>
        <description>Endpoint: Patients, in which none of the Smart Shock algorithms is programmed &quot;OFF&quot; during the first Follow-Up after a maximum length of 90 days and 180 days.</description>
        <time_frame>90 days or 180 days</time_frame>
        <population>Patients with data available at 90 days</population>
        <group_list>
          <group group_id="O1">
            <title>ICD Patients (Single Arm Study)</title>
            <description>Patients with an indication for an ICD implantation according to the guidelines treated with a Protecta™, Protecta™ XT or any equivalent following product</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With All Smart Shock Algorithms Are Programmed on</title>
          <description>Endpoint: Patients, in which none of the Smart Shock algorithms is programmed &quot;OFF&quot; during the first Follow-Up after a maximum length of 90 days and 180 days.</description>
          <population>Patients with data available at 90 days</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="427"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="300"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients, Without Shock Delivery Due to Smart Shock Technology</title>
        <description>Endpoint: Patients without shock delivery due to Smart Shock technology</description>
        <time_frame>24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ICD Patients (Single Arm Study)</title>
            <description>Patients with an indication for an ICD implantation according to the guidelines treated with a Protecta™, Protecta™ XT or any equivalent following product</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients, Without Shock Delivery Due to Smart Shock Technology</title>
          <description>Endpoint: Patients without shock delivery due to Smart Shock technology</description>
          <units>pat. w. at least 1 shock prevented in %</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="459"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Analysis of the Number of Patients With Primary Preventive Indication for an ICD That Develop VF Episodes.</title>
        <description>Endpoint: Number of primary prevention patients with at least one ventricular fibrillation (VF) episode detected and successfully treated by the ICD</description>
        <time_frame>24 months</time_frame>
        <population>Of all 272 patients with primary preventive indication, only 265 patients had device data available for the Follow-Up period.</population>
        <group_list>
          <group group_id="O1">
            <title>ICD Patients</title>
            <description>Patients with an indication for an ICD implantation according to the guidelines treated with a Protecta™, Protecta™ XT or any equivalent following product</description>
          </group>
        </group_list>
        <measure>
          <title>Analysis of the Number of Patients With Primary Preventive Indication for an ICD That Develop VF Episodes.</title>
          <description>Endpoint: Number of primary prevention patients with at least one ventricular fibrillation (VF) episode detected and successfully treated by the ICD</description>
          <population>Of all 272 patients with primary preventive indication, only 265 patients had device data available for the Follow-Up period.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="265"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients That Developed AT/AF</title>
        <description>Endpoint: patients with &gt;5 min atrial tachycardia/atrial fibrillation (AT/AF) in 'Daily Log' (Cardiac Compass)</description>
        <time_frame>24 months</time_frame>
        <population>Out of all patients analyzed (N=504), the patients with Single-Chamber-ICDs were excluded as these devices had no feature to identify AT/AF. This lead to N=367. Out of these 367 patients only 337 had Follow-Up data available whereas 30 patients only had implant data.</population>
        <group_list>
          <group group_id="O1">
            <title>ICD Patients (Single Arm Study)</title>
            <description>Patients with an indication for an ICD implantation according to the guidelines treated with a Protecta™, Protecta™ XT or any equivalent following product</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients That Developed AT/AF</title>
          <description>Endpoint: patients with &gt;5 min atrial tachycardia/atrial fibrillation (AT/AF) in 'Daily Log' (Cardiac Compass)</description>
          <population>Out of all patients analyzed (N=504), the patients with Single-Chamber-ICDs were excluded as these devices had no feature to identify AT/AF. This lead to N=367. Out of these 367 patients only 337 had Follow-Up data available whereas 30 patients only had implant data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="337"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Analysis of the Proportion of Patients in Which ICD Parameters Remain on Nominal Programming.</title>
        <description>Endpoint: Deviation of ICD parameter programming in comparison to nominal programming at the first Follow-Up ≥ 90 days post-implant.&#xD;
Nominals for dual chamber ICD or cardiac resynchronization therapy (CRT) devices:&#xD;
Lead Noise Discrimination = 'OnWithTimeout'&#xD;
Lead Failure Predictor = 'On'&#xD;
PR-Logic: AfibAflutter Rejection Rule = 'On'&#xD;
PR-Logic: Sinus Tach Rejection Rule = 'On'&#xD;
PR-Logic: Other 1:1 Rejection Rule = 'On'&#xD;
High Rate Timeout = 'Off'&#xD;
VF High Rate Timeout = 'Off'&#xD;
Wavelet Rejection Rule = 'On'&#xD;
VF Detection Interval = 320 and SVT Minimum Cycle Length = 260&#xD;
T-Wave Oversensing Discrimination = 'On'&#xD;
ATP During Charging = 'DuringCharging'&#xD;
Nominals for single chamber ICDs:&#xD;
Lead Noise Discrimination = 'OnWithTimeout'&#xD;
Lead Failure Predictor = 'On'&#xD;
High Rate Timeout = 'Off'&#xD;
VF High Rate Timeout = '0.75 min'&#xD;
Wavelet Rejection Rule = 'On'&#xD;
VF Detection Interval = 320 and SVT Minimum Cycle Length = 260&#xD;
T-Wave Oversensing D</description>
        <time_frame>At the first Follow-Up ≥ 90 days post-implant</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ICD Patients (Single Arm Study)</title>
            <description>Patients with an indication for an ICD implantation according to the guidelines treated with a Protecta™, Protecta™ XT or any equivalent following product</description>
          </group>
        </group_list>
        <measure>
          <title>Analysis of the Proportion of Patients in Which ICD Parameters Remain on Nominal Programming.</title>
          <description>Endpoint: Deviation of ICD parameter programming in comparison to nominal programming at the first Follow-Up ≥ 90 days post-implant.&#xD;
Nominals for dual chamber ICD or cardiac resynchronization therapy (CRT) devices:&#xD;
Lead Noise Discrimination = 'OnWithTimeout'&#xD;
Lead Failure Predictor = 'On'&#xD;
PR-Logic: AfibAflutter Rejection Rule = 'On'&#xD;
PR-Logic: Sinus Tach Rejection Rule = 'On'&#xD;
PR-Logic: Other 1:1 Rejection Rule = 'On'&#xD;
High Rate Timeout = 'Off'&#xD;
VF High Rate Timeout = 'Off'&#xD;
Wavelet Rejection Rule = 'On'&#xD;
VF Detection Interval = 320 and SVT Minimum Cycle Length = 260&#xD;
T-Wave Oversensing Discrimination = 'On'&#xD;
ATP During Charging = 'DuringCharging'&#xD;
Nominals for single chamber ICDs:&#xD;
Lead Noise Discrimination = 'OnWithTimeout'&#xD;
Lead Failure Predictor = 'On'&#xD;
High Rate Timeout = 'Off'&#xD;
VF High Rate Timeout = '0.75 min'&#xD;
Wavelet Rejection Rule = 'On'&#xD;
VF Detection Interval = 320 and SVT Minimum Cycle Length = 260&#xD;
T-Wave Oversensing D</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="427"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="421"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Analysis of the Positive Predictive Value of the Investigated ICD Oversensing Algorithms</title>
        <description>Endpoint: Episode classified by the device as T-wave Oversensing or 'Noise'.</description>
        <time_frame>through study completion</time_frame>
        <population>In total, 71 episodes were detected by the device and classified as T-wave Oversensing or Noise, but only 20 had electrogram (EGM) strips available. The analysis of the positive predictive value (PPV) was performed on these 20 episodes only. The number of true positives was 20. The number of false positives was 0.</population>
        <group_list>
          <group group_id="O1">
            <title>ICD Patients (Single Arm Study)</title>
            <description>Patients with an indication for an ICD implantation according to the guidelines treated with a Protecta™, Protecta™ XT or any equivalent following product</description>
          </group>
        </group_list>
        <measure>
          <title>Analysis of the Positive Predictive Value of the Investigated ICD Oversensing Algorithms</title>
          <description>Endpoint: Episode classified by the device as T-wave Oversensing or 'Noise'.</description>
          <population>In total, 71 episodes were detected by the device and classified as T-wave Oversensing or Noise, but only 20 had electrogram (EGM) strips available. The analysis of the positive predictive value (PPV) was performed on these 20 episodes only. The number of true positives was 20. The number of false positives was 0.</population>
          <units>Positive Predictive Value in %</units>
          <param>Number</param>
          <units_analyzed>episodes with EGM strips</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>episodes with EGM strips</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All devices that were used in this study are market-released and were only used within their approved indication. Therefore vigilance reporting was performed in the context of Post Market Surveillance. Adverse event information was therefore not collected during this study.</time_frame>
      <desc>All devices that were used in this study are market-released and were only used within their approved indication. Therefore vigilance reporting was performed in the context of Post Market Surveillance. Adverse event information was therefore not collected during this study.</desc>
      <group_list>
        <group group_id="E1">
          <title>ICD Patients (Single Arm Study)</title>
          <description>Patients with an indication for an ICD implantation according to the guidelines treated with a Protecta™, Protecta™ XT or any equivalent following product</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </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="0"/>
              </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 sponsor reviews publication within 3 weeks after submission of a manuscript. The sponsor can deny publication if the publication is not in accordance with the protocol, the publication would compromise business secrets or the issuing of patents or if the content of the publication is technically incorrect or may compromise other interests of the sponsor.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>No electronic case report form data available / only device data used&#xD;
Appropriateness of classification of Smart Shock algorithms not established; i.e. episode classification was limited to secondary endpoint 6&#xD;
No source data verification</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>ProSA clinical research contact</name_or_title>
      <organization>Medtronic GmbH</organization>
      <phone>004921598149 ext 0</phone>
      <email>rs.dusclinicalcooperation@medtronic.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/NCT01714921
org study id: CEN_G_CA_13
nct id: NCT01714921
lead sponsor: 
collaborator: 
has dmc: No
ProSA is a prospective, non-randomized, multicenter, observational study investigating the
      utilization and effectiveness of the Smart Shock™ algorithm in ICD patients treated with a
      Protecta™, Protecta™ XT or any equivalent following product.
observational model: Cohort
time perspective: Prospective
measure: Analysis of Change of Episodes Inappropriately Treated by Shock Therapy Due to Smart Shock™ Technology.
time frame: 24 months
description: Smart Shock technology is a suite of algorithms that are designed to prevent inappropriate shocks in ICD&CRT patients.
Endpoints for the primary objective:
Episodes with shock therapy
Episodes without shock delivery due to Smart Shock™ technology
Episodes classified as supraventricular tachycardia (SVT) by PR Logic
Episodes classified as SVT by Wavelet
Shock therapy suppressed by T-wave Discrimination
Shock therapy suppressed by Lead Noise Discrimination
Shock therapy suppressed by Confirmation +
Episode with successful anti-tachycardia pacing (ATP) During Charging
measure: Number of Patients With All Smart Shock Algorithms Are Programmed on
time frame: 90 days or 180 days
description: Endpoint: Patients, in which none of the Smart Shock algorithms is programmed "OFF" during the first Follow-Up after a maximum length of 90 days and 180 days.
measure: Percentage of Patients, Without Shock Delivery Due to Smart Shock Technology
time frame: 24 months
description: Endpoint: Patients without shock delivery due to Smart Shock technology
measure: Analysis of the Number of Patients With Primary Preventive Indication for an ICD That Develop VF Episodes.
time frame: 24 months
description: Endpoint: Number of primary prevention patients with at least one ventricular fibrillation (VF) episode detected and successfully treated by the ICD
measure: Number of Patients That Developed AT/AF
time frame: 24 months
description: Endpoint: patients with >5 min atrial tachycardia/atrial fibrillation (AT/AF) in 'Daily Log' (Cardiac Compass)
measure: Analysis of the Proportion of Patients in Which ICD Parameters Remain on Nominal Programming.
time frame: At the first Follow-Up ≥ 90 days post-implant
description: Endpoint: Deviation of ICD parameter programming in comparison to nominal programming at the first Follow-Up ≥ 90 days post-implant.
Nominals for dual chamber ICD or cardiac resynchronization therapy (CRT) devices:
Lead Noise Discrimination = 'OnWithTimeout'
Lead Failure Predictor = 'On'
PR-Logic: AfibAflutter Rejection Rule = 'On'
PR-Logic: Sinus Tach Rejection Rule = 'On'
PR-Logic: Other 1:1 Rejection Rule = 'On'
High Rate Timeout = 'Off'
VF High Rate Timeout = 'Off'
Wavelet Rejection Rule = 'On'
VF Detection Interval = 320 and SVT Minimum Cycle Length = 260
T-Wave Oversensing Discrimination = 'On'
ATP During Charging = 'DuringCharging'
Nominals for single chamber ICDs:
Lead Noise Discrimination = 'OnWithTimeout'
Lead Failure Predictor = 'On'
High Rate Timeout = 'Off'
VF High Rate Timeout = '0.75 min'
Wavelet Rejection Rule = 'On'
VF Detection Interval = 320 and SVT Minimum Cycle Length = 260
T-Wave Oversensing D
measure: Analysis of the Positive Predictive Value of the Investigated ICD Oversensing Algorithms
time frame: through study completion
description: Endpoint: Episode classified by the device as T-wave Oversensing or 'Noise'.
arm group label: ICD patients
description: Patients with an indication for an ICD implantation according to the guidelines treated with a Protecta™, Protecta™ XT or any equivalent following product
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: No electronic case report form data available / only device data used
Appropriateness of classification of Smart Shock algorithms not established; i.e. episode classification was limited to secondary endpoint 6
No source data verification
point of contact: 