<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/NCT01733368</url>
  </required_header>
  <id_info>
    <org_study_id>CR-1 2-015-SP-HF</org_study_id>
    <nct_id>NCT01733368</nct_id>
  </id_info>
  <brief_title>QUARTO-II Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead</brief_title>
  <acronym>QUARTO-II</acronym>
  <official_title>Observational Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Devices</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Optimization and evolution of the patient will be evaluated over 6 months after the implant.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patient will be enrolled into the study after Informed Consent signature and&#xD;
      CRT-D+quadripolar (QuartetTM) LV lead.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Responder Patients (Structural Remodelling)</measure>
    <time_frame>6 months after implant</time_frame>
    <description>Structural remodelling is defined as a reduction &gt;15% in Left Ventricle End Systolic Volume (LVESV), measured 6 months after implant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety Outcomes in CRT Responders and Non-Responders</measure>
    <time_frame>6 months after implant</time_frame>
    <description>Mortality rate,&#xD;
Rate of cardiovascular hospitalizations and for any cause or&#xD;
Combined endpoint (death and all-cause hospitalization)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Responder Patients With Non-conventional Left Ventricular Pacing Vector</measure>
    <time_frame>6 months after implant</time_frame>
    <description>Response is defined as a reduction &gt;15% in LVESV, measured 6 months after implant.&#xD;
Non-conventional pacing vectors are the pacing vectors exclusive to the Quartet LV quadripolar lead, not available in the conventional bipolar leads.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Responder Patients With Conventional Left Ventricular Pacing Vector</measure>
    <time_frame>6 months after implant</time_frame>
    <description>Response is defined as a reduction &gt;15% in LVESV, measured 6 months after implant.&#xD;
Conventional pacing vectors are the pacing vectors available both in the Quartet LV quadripolar lead and in the conventional bipolar leads.</description>
  </secondary_outcome>
  <enrollment type="Actual">198</enrollment>
  <condition>Heart Failure</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Heart failure patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with implanted CRT-D device and a QuartetTM quadripolar lead by St. Jude&#xD;
             Medical in the left ventricle.&#xD;
&#xD;
          -  Patient with an echocardiographic study performed during 1 month prior to the implant&#xD;
             and in whom End Systolic Volume of the Left Ventricle (LVESV) has been measured&#xD;
&#xD;
          -  Patients who have granted their informed consent.&#xD;
&#xD;
          -  Patients above 18 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients that have been previously resynchronized.&#xD;
&#xD;
          -  Patients with aortic stenosis or aortic valve prosthesis&#xD;
&#xD;
          -  Patients who are or may potentially be pregnant.&#xD;
&#xD;
          -  Patients with a life expectancy &lt;12 months.&#xD;
&#xD;
          -  Patients who cannot attend the monitoring visits established by the protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Javier Alzueta, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clínico Universitario Virgen de la Victoria</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de la Victoria</name>
      <address>
        <city>Málaga</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <results_first_submitted>May 31, 2017</results_first_submitted>
  <results_first_submitted_qc>February 26, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">March 1, 2018</results_first_posted>
  <last_update_submitted>January 31, 2019</last_update_submitted>
  <last_update_submitted_qc>January 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CRT</keyword>
  <keyword>Optimization</keyword>
  <keyword>Responders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Quadripolar Left Ventricular Lead (Quartet Lead)</title>
          <description>Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="198"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="167"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Quadripolar Left Ventricular Lead (Quartet Lead)</title>
          <description>Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="198"/>
          </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="66.01" spread="10.22"/>
                  </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="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="146"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>New York Heart Association (NYHA) Classification</title>
          <description>The NYHA Functional Classification provides a simple way of classifying the extent of heart failure:&#xD;
I Cardiac disease, but no symptoms and no limitation in ordinary physical activity.&#xD;
II Mild symptoms and slight limitation during ordinary activity. III Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest.&#xD;
IV Severe limitations. Experiences symptoms even while at rest.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>NYHA I</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>NYHA II</title>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>NYHA III</title>
                  <measurement_list>
                    <measurement group_id="B1" value="111"/>
                  </measurement_list>
                </category>
                <category>
                  <title>NYHA IV</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cardiovascular Etiology: Ischemic, Non-ischemic</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Ischemic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-ischemic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>QRS Duration</title>
          <units>miliseconds (ms)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="168" spread="22.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>QRS Morphology</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Left Bundle Branch Block (LBBB)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="168"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Right Bundle Branch Block (RBBB)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Interventricular Conduction Delay (IVCD)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ejection Fraction (EF)</title>
          <units>percentage (%)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.87" spread="7.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Left Ventricular End Systolic Volume (LVESV)</title>
          <units>milliliters (ml)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="155.17" spread="75.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Responder Patients (Structural Remodelling)</title>
        <description>Structural remodelling is defined as a reduction &gt;15% in Left Ventricle End Systolic Volume (LVESV), measured 6 months after implant.</description>
        <time_frame>6 months after implant</time_frame>
        <population>Patients with the 6-month follow-up completed and echocardiographic measurements available</population>
        <group_list>
          <group group_id="O1">
            <title>Quadripolar Left Ventricular Lead (Quartet Lead)</title>
            <description>Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Responder Patients (Structural Remodelling)</title>
          <description>Structural remodelling is defined as a reduction &gt;15% in Left Ventricle End Systolic Volume (LVESV), measured 6 months after implant.</description>
          <population>Patients with the 6-month follow-up completed and echocardiographic measurements available</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="146"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Safety Outcomes in CRT Responders and Non-Responders</title>
        <description>Mortality rate,&#xD;
Rate of cardiovascular hospitalizations and for any cause or&#xD;
Combined endpoint (death and all-cause hospitalization)</description>
        <time_frame>6 months after implant</time_frame>
        <population>Patients experiencing clinical safety event prior to the 6-month follow-up visit.</population>
        <group_list>
          <group group_id="O1">
            <title>6-Month CRT Responder</title>
            <description>Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead and classified as a responder at 6 months of follow-up.</description>
          </group>
          <group group_id="O2">
            <title>6-Month CRT Non-Responder</title>
            <description>Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead and classified as a non-responder at 6 months of follow-up.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety Outcomes in CRT Responders and Non-Responders</title>
          <description>Mortality rate,&#xD;
Rate of cardiovascular hospitalizations and for any cause or&#xD;
Combined endpoint (death and all-cause hospitalization)</description>
          <population>Patients experiencing clinical safety event prior to the 6-month follow-up visit.</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="94"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>All-cause hospitalization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Deaths &amp; Hospitalizations</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Responder Patients With Non-conventional Left Ventricular Pacing Vector</title>
        <description>Response is defined as a reduction &gt;15% in LVESV, measured 6 months after implant.&#xD;
Non-conventional pacing vectors are the pacing vectors exclusive to the Quartet LV quadripolar lead, not available in the conventional bipolar leads.</description>
        <time_frame>6 months after implant</time_frame>
        <population>Patients with the 6-month follow-up completed, echocardiographic measurements available and programmed with non-conventional LV pacing vector</population>
        <group_list>
          <group group_id="O1">
            <title>Quadripolar Left Ventricular Lead (Quartet Lead)</title>
            <description>Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Responder Patients With Non-conventional Left Ventricular Pacing Vector</title>
          <description>Response is defined as a reduction &gt;15% in LVESV, measured 6 months after implant.&#xD;
Non-conventional pacing vectors are the pacing vectors exclusive to the Quartet LV quadripolar lead, not available in the conventional bipolar leads.</description>
          <population>Patients with the 6-month follow-up completed, echocardiographic measurements available and programmed with non-conventional LV pacing vector</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="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Responder Patients With Conventional Left Ventricular Pacing Vector</title>
        <description>Response is defined as a reduction &gt;15% in LVESV, measured 6 months after implant.&#xD;
Conventional pacing vectors are the pacing vectors available both in the Quartet LV quadripolar lead and in the conventional bipolar leads.</description>
        <time_frame>6 months after implant</time_frame>
        <population>Patients with the 6-month follow-up completed, echocardiographic measurements available and programmed with a conventional pacing vector</population>
        <group_list>
          <group group_id="O1">
            <title>Quadripolar Left Ventricular Lead (Quartet Lead)</title>
            <description>Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Responder Patients With Conventional Left Ventricular Pacing Vector</title>
          <description>Response is defined as a reduction &gt;15% in LVESV, measured 6 months after implant.&#xD;
Conventional pacing vectors are the pacing vectors available both in the Quartet LV quadripolar lead and in the conventional bipolar leads.</description>
          <population>Patients with the 6-month follow-up completed, echocardiographic measurements available and programmed with a conventional pacing vector</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="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months after CRT implant</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Quadripolar Left Ventricular Lead (Quartet Lead)</title>
          <description>Patients implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and the Quartet Left Ventricular (LV) quadripolar lead</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="198"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="50" subjects_at_risk="198"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial or Ventricular arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="198"/>
              </event>
              <event>
                <sub_title>Cardiac arrest and death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
              </event>
              <event>
                <sub_title>Cardiac Tamponade</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="198"/>
              </event>
              <event>
                <sub_title>Exacerbacion of Heart Failulre</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="198"/>
              </event>
              <event>
                <sub_title>Exacerbacion of Heart Failulre and Death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
              </event>
              <event>
                <sub_title>Myocardial infartion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
              </event>
              <event>
                <sub_title>stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Malignant tumor</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Calculous Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis due to amiodarone and statins treatment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Elevated Pacing Thresholds</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
              </event>
              <event>
                <sub_title>Lead Dislodgement</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="198"/>
              </event>
              <event>
                <sub_title>Phrenic Nerve/Diaphragmatic/Extracardiac stimulation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="198"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Bleeding/Hematoma</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="198"/>
              </event>
              <event>
                <sub_title>Cardiac perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="198"/>
              </event>
              <event>
                <sub_title>Sepsis and Death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="198"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Inappropriate ATP</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
              </event>
              <event>
                <sub_title>phrenic nerve/diaphragmatic/extracardiac stimulation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="198"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Upgrade of the device to DDD by adding atrial lead</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
              </event>
              <event>
                <sub_title>Shiver and physical discomfort during implant</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
              </event>
              <event>
                <sub_title>Bleeding/Hematoma</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="198"/>
              </event>
              <event>
                <sub_title>carbon dioxide narcosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
              </event>
              <event>
                <sub_title>Coronary sinus dissection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
              </event>
              <event>
                <sub_title>Nause and vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
              </event>
              <event>
                <sub_title>Pain in the implant site</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="198"/>
              </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 NOT 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>Dr. Javier Alzueta Rodríguez</name_or_title>
      <organization>Hospital Clinico Universitario Virgen de la Victoria</organization>
      <phone>951 03 20 00</phone>
      <email>jalzueta@telefonica.net</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/NCT01733368
org study id: CR-1 2-015-SP-HF
nct id: NCT01733368
lead sponsor: 
has dmc: No
Optimization and evolution of the patient will be evaluated over 6 months after the implant.
Patient will be enrolled into the study after Informed Consent signature and
      CRT-D+quadripolar (QuartetTM) LV lead.
observational model: Other
time perspective: Prospective
measure: Number of Responder Patients (Structural Remodelling)
time frame: 6 months after implant
description: Structural remodelling is defined as a reduction >15% in Left Ventricle End Systolic Volume (LVESV), measured 6 months after implant.
measure: Safety Outcomes in CRT Responders and Non-Responders
time frame: 6 months after implant
description: Mortality rate,
Rate of cardiovascular hospitalizations and for any cause or
Combined endpoint (death and all-cause hospitalization)
measure: Number of Responder Patients With Non-conventional Left Ventricular Pacing Vector
time frame: 6 months after implant
description: Response is defined as a reduction >15% in LVESV, measured 6 months after implant.
Non-conventional pacing vectors are the pacing vectors exclusive to the Quartet LV quadripolar lead, not available in the conventional bipolar leads.
measure: Number of Responder Patients With Conventional Left Ventricular Pacing Vector
time frame: 6 months after implant
description: Response is defined as a reduction >15% in LVESV, measured 6 months after implant.
Conventional pacing vectors are the pacing vectors available both in the Quartet LV quadripolar lead and in the conventional bipolar leads.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Javier Alzueta, MD
role: Principal Investigator
affiliation: Hospital Clínico Universitario Virgen de la Victoria
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No
ipd description: No plan
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 