<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/NCT02243696</url>
  </required_header>
  <id_info>
    <org_study_id>P980023/S057</org_study_id>
    <nct_id>NCT02243696</nct_id>
  </id_info>
  <brief_title>Protego DF4 Post Approval Registry</brief_title>
  <official_title>Protego DF4 Post Approval Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biotronik, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biotronik, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this registry study is to confirm the long-term safety and reliability of the&#xD;
      Protego DF4 right ventricular lead.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    On April 15, 2019, BIOTRONIK received FDA approval to transition the ongoing Protego DF4 Post&#xD;
    Approval Registry to a new EP PASSION real-world data methodology.&#xD;
  </why_stopped>
  <start_date type="Actual">September 27, 2014</start_date>
  <completion_date type="Actual">April 17, 2019</completion_date>
  <primary_completion_date type="Actual">April 17, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Percentage of Subjects With No Protego DF4 Lead Adverse Event</measure>
    <time_frame>Up to 4.5 years</time_frame>
    <description>Evaluate the percentage of subjects without an adverse event related to the Protego DF4 lead or header through 5 years. The endpoint is analyzed as the adverse event free-rate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Protego DF4 Lead Safety-Individual Adverse Event-Free Rate</measure>
    <time_frame>Up to 4.5 years</time_frame>
    <description>Evaluate the individual types of adverse events contributing to primary outcome measure 'Protego DF4 Lead Safety-Overall Adverse Event-Free Rate'.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Protego DF4 Lead Pacing Threshold Measurement</measure>
    <time_frame>Up to 4.5 years</time_frame>
    <description>Pacing threshold measurements at pulse width of 0.4 or 0.5 ms for the Protego DF4 leads through 5 years of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Protego DF4 Lead Shock Impedance</measure>
    <time_frame>Up to 4.5 years</time_frame>
    <description>Shock impedance measurements for the Protego DF4 leads through 5 years of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With no Adverse Events Excluded From Primary Objectives</measure>
    <time_frame>Up to 4.5 years</time_frame>
    <description>The overall percentage of patients without adverse events that were excluded from the primary objectives and occurred through 5 years of follow-up. This was evaluated as an adverse event free-rate (AEFR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Protego DF4 Lead Sensing</measure>
    <time_frame>Up to 4.5 years</time_frame>
    <description>Sensing measurements for the Protego DF4 leads through 5 years of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Protego DF4 Lead Pacing Impedance</measure>
    <time_frame>Up to 4.5 years</time_frame>
    <description>Pacing impedance measurements for the Protego DF4 leads through 5 years of follow-up.</description>
  </secondary_outcome>
  <enrollment type="Actual">1694</enrollment>
  <condition>Implantable Defibrillator User</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The patients selected for participation should be from the investigators' general patient&#xD;
        population according to the inclusion and exclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Implanted within the last 30 days or candidate for implantation of a BIOTRONIK ICD or&#xD;
             CRT-D DF4 compatible system along with the Protego DF4 lead&#xD;
&#xD;
          -  Meets ICD or CRT-D system implant recommendations as defined in guidelines published&#xD;
             by relevant professional societies&#xD;
&#xD;
          -  Able to understand the nature of the registry and provide informed consent&#xD;
&#xD;
          -  Available for follow-up visits on a regular basis at the investigational site for the&#xD;
             expected 5 years of follow-up&#xD;
&#xD;
          -  Age greater than or equal to 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Enrolled in any investigational cardiac device trial&#xD;
&#xD;
          -  Planned cardiac surgical procedures or interventional measures within the next 6&#xD;
             months&#xD;
&#xD;
          -  Expected to receive heart transplantation or ventricular assist device within 1 year&#xD;
&#xD;
          -  Life expectancy of less than 1 year&#xD;
&#xD;
          -  Presence of another life-threatening, underlying illness separate from their cardiac&#xD;
             disorder&#xD;
&#xD;
          -  Patients reporting pregnancy at the time of enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Gadsden</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Avondale</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Peoria</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Escondido</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fountain Valley</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hawthorne</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santa Barbara</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Temecula</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Norwalk</city>
        <state>Connecticut</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brooksville</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Daytona Beach</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kissimmee</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New Smyrna Beach</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Winter Park</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Zephyrhills</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Alton</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Aurora</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Schaumburg</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Owensboro</city>
        <state>Kentucky</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lafayette</city>
        <state>Louisiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lake Charles</city>
        <state>Louisiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bangor</city>
        <state>Maine</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cumberland</city>
        <state>Maryland</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rochester Hills</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wyoming</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ypsilanti</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Clifton</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Middletown</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Steubenville</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Anderson</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lancaster</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rock Hill</city>
        <state>South Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Corpus Christi</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kingwood</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tomball</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chesapeake</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fredericksburg</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <results_first_submitted>April 8, 2020</results_first_submitted>
  <results_first_submitted_qc>April 8, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 22, 2020</results_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 14, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT02243696/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>BIOTRONIK Protego DF4 Lead</title>
          <description>Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1694"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1694"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="282"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="79"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject No Longer has Study System</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject Withdrawn by Investigator</title>
              <participants_list>
                <participants group_id="P1" count="273"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Terminated for EP PASSION</title>
              <participants_list>
                <participants group_id="P1" count="961"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>BIOTRONIK Protego DF4 Lead</title>
          <description>Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1694"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1694"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.5" spread="12.49"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1694"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="481"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1213"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1694"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="177"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1326"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="191"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1694"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="340"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1130"/>
                  </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="181"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <population>Baseline characteristics are provided when available, subjects without an available baseline characteristic are not included in the number of participants analyzed for that characteristic.</population>
          <units>pounds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1656"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="196.3" spread="51.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <population>Baseline characteristics are provided when available, subjects without an available baseline characteristic are not included in the number of participants analyzed for that characteristic.</population>
          <units>inches</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1653"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.7" spread="4.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects With No Protego DF4 Lead Adverse Event</title>
        <description>Evaluate the percentage of subjects without an adverse event related to the Protego DF4 lead or header through 5 years. The endpoint is analyzed as the adverse event free-rate.</description>
        <time_frame>Up to 4.5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>BIOTRONIK Protego DF4 Lead</title>
            <description>Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With No Protego DF4 Lead Adverse Event</title>
          <description>Evaluate the percentage of subjects without an adverse event related to the Protego DF4 lead or header through 5 years. The endpoint is analyzed as the adverse event free-rate.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1694"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.7" lower_limit="98.04" upper_limit="99.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Protego DF4 Lead Safety-Individual Adverse Event-Free Rate</title>
        <description>Evaluate the individual types of adverse events contributing to primary outcome measure 'Protego DF4 Lead Safety-Overall Adverse Event-Free Rate'.</description>
        <time_frame>Up to 4.5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>BIOTRONIK Protego DF4 Lead</title>
            <description>Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header.</description>
          </group>
        </group_list>
        <measure>
          <title>Protego DF4 Lead Safety-Individual Adverse Event-Free Rate</title>
          <description>Evaluate the individual types of adverse events contributing to primary outcome measure 'Protego DF4 Lead Safety-Overall Adverse Event-Free Rate'.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1694"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lead oversensing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.41" lower_limit="0.17" upper_limit="0.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lead conductor fracture</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.30" lower_limit="0.10" upper_limit="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lead dislodgement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18" lower_limit="0.03" upper_limit="0.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lead impedance our of range, high</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" lower_limit="0.01" upper_limit="0.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lead impedance out of range, low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" lower_limit="0.01" upper_limit="0.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cardiac perforation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" lower_limit="0.01" upper_limit="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inability to extend helix</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" lower_limit="0.01" upper_limit="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lead failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" lower_limit="0.01" upper_limit="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Protego DF4 Lead Pacing Threshold Measurement</title>
        <description>Pacing threshold measurements at pulse width of 0.4 or 0.5 ms for the Protego DF4 leads through 5 years of follow-up.</description>
        <time_frame>Up to 4.5 years</time_frame>
        <population>A threshold measurement for the Protego lead using a pulse width of 0.4 or 0.5 ms was unavailable for one subject. This patient was excluded from the analysis of this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>BIOTRONIK Protego DF4 Lead</title>
            <description>Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header.</description>
          </group>
        </group_list>
        <measure>
          <title>Protego DF4 Lead Pacing Threshold Measurement</title>
          <description>Pacing threshold measurements at pulse width of 0.4 or 0.5 ms for the Protego DF4 leads through 5 years of follow-up.</description>
          <population>A threshold measurement for the Protego lead using a pulse width of 0.4 or 0.5 ms was unavailable for one subject. This patient was excluded from the analysis of this outcome measure.</population>
          <units>volts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1693"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.67" spread="0.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Protego DF4 Lead Shock Impedance</title>
        <description>Shock impedance measurements for the Protego DF4 leads through 5 years of follow-up.</description>
        <time_frame>Up to 4.5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>BIOTRONIK Protego DF4 Lead</title>
            <description>Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header.</description>
          </group>
        </group_list>
        <measure>
          <title>Protego DF4 Lead Shock Impedance</title>
          <description>Shock impedance measurements for the Protego DF4 leads through 5 years of follow-up.</description>
          <units>Ohms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1694"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.5" spread="13.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects With no Adverse Events Excluded From Primary Objectives</title>
        <description>The overall percentage of patients without adverse events that were excluded from the primary objectives and occurred through 5 years of follow-up. This was evaluated as an adverse event free-rate (AEFR).</description>
        <time_frame>Up to 4.5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>BIOTRONIK Protego DF4 Lead</title>
            <description>Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With no Adverse Events Excluded From Primary Objectives</title>
          <description>The overall percentage of patients without adverse events that were excluded from the primary objectives and occurred through 5 years of follow-up. This was evaluated as an adverse event free-rate (AEFR).</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1694"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.73" lower_limit="89.25" upper_limit="92.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Protego DF4 Lead Sensing</title>
        <description>Sensing measurements for the Protego DF4 leads through 5 years of follow-up.</description>
        <time_frame>Up to 4.5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>BIOTRONIK Protego DF4 Lead</title>
            <description>Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header.</description>
          </group>
        </group_list>
        <measure>
          <title>Protego DF4 Lead Sensing</title>
          <description>Sensing measurements for the Protego DF4 leads through 5 years of follow-up.</description>
          <units>millivolts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1694"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.70" spread="5.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Protego DF4 Lead Pacing Impedance</title>
        <description>Pacing impedance measurements for the Protego DF4 leads through 5 years of follow-up.</description>
        <time_frame>Up to 4.5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>BIOTRONIK Protego DF4 Lead</title>
            <description>Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header.</description>
          </group>
        </group_list>
        <measure>
          <title>Protego DF4 Lead Pacing Impedance</title>
          <description>Pacing impedance measurements for the Protego DF4 leads through 5 years of follow-up.</description>
          <units>Ohms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1694"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="552.3" spread="121.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 4.5 years</time_frame>
      <desc>According to the study protocol, sites were required to report all patient deaths and all adverse events that were considered related to the implant procedure, implanted pulse generator, or implanted leads. Adverse events determined to be not related to the implant procedure, implanted pulse generator, or implanted leads were not collected.&#xD;
Reported adverse events were defined as a serious or 'other' adverse event according to the clinicaltrials.gov definition.</desc>
      <group_list>
        <group group_id="E1">
          <title>BIOTRONIK Protego DF4 Lead</title>
          <description>Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header.</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="282" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="145" subjects_at_risk="1694"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial lead conductor fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Atrial lead dislodgement</sub_title>
                <counts group_id="E1" events="21" subjects_affected="21" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Atrial lead high pacing threshold</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Cardiac perforation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Inability to defibrillate successfully with the Protego lead</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>LV lead diaphragmatic stimulation</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>LV lead dislodgement</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>LV lead high pacing threshold</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>LV lead impedance out of range, high impedance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>LV lead intermittent capture / no lead capture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Premature battery depletion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Pulse generator failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Pulse generator migration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>RV lead conductor fracture</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>RV lead dislodgement</sub_title>
                <counts group_id="E1" events="27" subjects_affected="26" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>RV lead failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>RV lead high pacing threshold</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>RV lead impedance out of range, high impedance</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>RV lead impedance out of range, low impedance</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>RV lead intermittent capture / no lead capture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>RV lead oversensing not due to external noise</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>RV lead undersensing or loss of sensing</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1694"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Twiddler's syndrome</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1694"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Primary infection</sub_title>
                <counts group_id="E1" events="21" subjects_affected="21" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Secondary infection</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="1694"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin erosion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1694"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Cardiac perforation with or without tamponade</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Coronary sinus dissection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Loose set-screw</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Pocket pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Venous occlusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1694"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>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="144" subjects_at_risk="1694"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial lead dislodgement</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Atrial lead high pacing threshold</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Atrial lead impedance out of range, high impedance</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Atrial lead impedance out of range, low impedance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Atrial lead intermittent capture / no lead capture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Bent connector pin noted during implant procedure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Inability to extend helix during implant procedure</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Inability to successfully implant Protego lead</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>LV lead diaphragmatic stimulation</sub_title>
                <counts group_id="E1" events="38" subjects_affected="31" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>LV lead dislodgement</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>LV lead high pacing threshold</sub_title>
                <counts group_id="E1" events="67" subjects_affected="59" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>LV lead impedance out of range, high impedance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>LV lead intermittent capture / no lead capture</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>LV lead oversensing not due to external noise</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Pulse generator back-up mode initiated</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>RV lead diaphragmatic stimulation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>RV lead high pacing threshold</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>RV lead impedance out of range, high impedance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>RV lead impedance out of range, low impedance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>RV lead intermittent capture / no lead capture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>RV lead oversensing not due to external noise</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>RV lead undersensing or loss of sensing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1694"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Lightheadedness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1694"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin erosion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1694"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Damage to lead during procedure (e.g. accidental cut to lead body during pocket revision, device rep</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Inability to successfully implant Protego lead due to patient anatomy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Pocket pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>RA lead dislodgement during a procedure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>RV lead dislodgement during a procedure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Venous occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1694"/>
              </event>
              <event>
                <sub_title>Venous thrombosis without pulmonary embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1694"/>
              </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>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Studies Engineer Manager</name_or_title>
      <organization>BIOTRONIK, Inc.</organization>
      <phone>1-800-547-0394</phone>
      <email>crystal.miller@biotronik.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/NCT02243696
org study id: P980023/S057
nct id: NCT02243696
lead sponsor: 
has dmc: No
The purpose of this registry study is to confirm the long-term safety and reliability of the
      Protego DF4 right ventricular lead.
observational model: Case-Only
time perspective: Prospective
measure: Percentage of Subjects With No Protego DF4 Lead Adverse Event
time frame: Up to 4.5 years
description: Evaluate the percentage of subjects without an adverse event related to the Protego DF4 lead or header through 5 years. The endpoint is analyzed as the adverse event free-rate.
measure: Protego DF4 Lead Safety-Individual Adverse Event-Free Rate
time frame: Up to 4.5 years
description: Evaluate the individual types of adverse events contributing to primary outcome measure 'Protego DF4 Lead Safety-Overall Adverse Event-Free Rate'.
measure: Protego DF4 Lead Pacing Threshold Measurement
time frame: Up to 4.5 years
description: Pacing threshold measurements at pulse width of 0.4 or 0.5 ms for the Protego DF4 leads through 5 years of follow-up.
measure: Protego DF4 Lead Shock Impedance
time frame: Up to 4.5 years
description: Shock impedance measurements for the Protego DF4 leads through 5 years of follow-up.
measure: Percentage of Subjects With no Adverse Events Excluded From Primary Objectives
time frame: Up to 4.5 years
description: The overall percentage of patients without adverse events that were excluded from the primary objectives and occurred through 5 years of follow-up. This was evaluated as an adverse event free-rate (AEFR).
measure: Protego DF4 Lead Sensing
time frame: Up to 4.5 years
description: Sensing measurements for the Protego DF4 leads through 5 years of follow-up.
measure: Protego DF4 Lead Pacing Impedance
time frame: Up to 4.5 years
description: Pacing impedance measurements for the Protego DF4 leads through 5 years of follow-up.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: United States
responsible party type: Sponsor
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