<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/NCT03257436</url>
  </required_header>
  <id_info>
    <org_study_id>92050975</org_study_id>
    <nct_id>NCT03257436</nct_id>
  </id_info>
  <brief_title>Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918)</brief_title>
  <acronym>SMARTMSP</acronym>
  <official_title>Strategic Management to Improve CRT Using Multi-Site Pacing Post Approval Study (Reference # C1918)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Scientific Corporation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, multi-center, single arm, post approval study to be conducted in the United&#xD;
      States.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evaluate the effectiveness of Boston Scientific (BSC)'s LV MSP (Left Ventricular MultiSite&#xD;
      Pacing) feature in the Resonate family of CRT-D devices and confirm safety in a post approval&#xD;
      study when used in accordance with its approved labeling.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 5, 2018</start_date>
  <completion_date type="Actual">November 19, 2020</completion_date>
  <primary_completion_date type="Actual">November 19, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>LV MSP Feature Related Complication-Free Rate</measure>
    <time_frame>Between 6 month visit and the 12 month visit in non-responders with LV MSP on for any duration.</time_frame>
    <description>Proportion of subjects free from LVMSP feature related complications at 12 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of LV MSP Group Subjects With an Improved Clinical Composite Score at 12 Months</measure>
    <time_frame>12 Month Follow Up</time_frame>
    <description>Proportion of non-responders with LV MSP enabled at 6 months who were responders at 12 months. Responders were defined as having an Improved Clinical Composite Score at 12 Months.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">586</enrollment>
  <condition>Left Ventricular Dysfunction</condition>
  <arm_group>
    <arm_group_label>Single Arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CRT-D</intervention_name>
    <description>Left Ventricular MultiSite Pacing</description>
    <arm_group_label>Single Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects who received de novo implantation of BSC's Resonate family of CRT-D devices&#xD;
             with the LV MSP feature4 and BSC's ACUITYTM X4 LV Quadripolar leads. A Resonate family&#xD;
             of CRT-D device upgrade from previous single or dual chamber pacemaker or ICD&#xD;
             implantation is allowed.&#xD;
&#xD;
          2. Subjects must meet BSC labeled indication for CRT-D implantation.&#xD;
&#xD;
          3. Subjects must have a functional RA lead and RV lead implanted&#xD;
&#xD;
          4. Subjects who are willing and capable of providing informed consent&#xD;
&#xD;
          5. Subjects who are willing and capable of participating in all testing/visits associated&#xD;
             with this clinical study at an approved clinical study center and at the intervals&#xD;
             defined by this protocol&#xD;
&#xD;
          6. Subjects who are age 18 and above, or of legal age to give informed consent specific&#xD;
             to state and national law&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who received LV pacing prior to receiving the Resonate family of CRT-D system&#xD;
             implantation.&#xD;
&#xD;
          2. Subjects who received the LV MSP therapy post CRT-D implantation but prior to&#xD;
             enrollment&#xD;
&#xD;
          3. Subjects with documented history of permanent AF&#xD;
&#xD;
          4. Subjects with documented permanent complete AV block&#xD;
&#xD;
          5. Subjects who are expected to receive a heart transplant during the 12 months course of&#xD;
             the study&#xD;
&#xD;
          6. Subjects with documented life expectancy of less than 12 months&#xD;
&#xD;
          7. Subjects who enrolled in any other concurrent study or registry, with the exception of&#xD;
             mandatory national or governmental registry, without prior written approval from BSC&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Saba Samir</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mobile Infirmary Medical Center</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Phoenix Cardiovascular Group</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Associates of NEA</name>
      <address>
        <city>Jonesboro</city>
        <state>Arkansas</state>
        <zip>72401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foothill Cardiology Medical Group</name>
      <address>
        <city>Arcadia</city>
        <state>California</state>
        <zip>91007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chula Vista Cardiac Center</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Los Angeles Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Desert Heart Rhythm Consultants</name>
      <address>
        <city>Palm Springs</city>
        <state>California</state>
        <zip>92262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Associates Medical Group</name>
      <address>
        <city>Ventura</city>
        <state>California</state>
        <zip>93003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delray Medical Center</name>
      <address>
        <city>Delray Beach</city>
        <state>Florida</state>
        <zip>33484</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UF Health Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Hospital Waterman</name>
      <address>
        <city>Lake Mary</city>
        <state>Florida</state>
        <zip>32746</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tallahassee Research Institute</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Augusta University</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alexian Brothers Hospital Network</name>
      <address>
        <city>Elk Grove Village</city>
        <state>Illinois</state>
        <zip>60007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle Foundation Hospital</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkview Hospital Inc</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norton Heart Specialist</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Cardiovascular Specialists</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedStar Heart and Vascular Institute</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ascension St. John Hospital &amp; Medical Center</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Genesys Regional Medical Center</name>
      <address>
        <city>Grand Blanc</city>
        <state>Michigan</state>
        <zip>48439</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Mary's of Michigan Research Institute at Covenant Medical Ceter</name>
      <address>
        <city>Saginaw</city>
        <state>Michigan</state>
        <zip>48601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMMC- Division of Cardiology</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Lukes Hospital</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Billings Clinic</name>
      <address>
        <city>Billings</city>
        <state>Montana</state>
        <zip>59101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Physicians Clinic Heart Consultants</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deborah Heart and Lung Center</name>
      <address>
        <city>Browns Mills</city>
        <state>New Jersey</state>
        <zip>08015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hackensack University Medical Canter</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Durham VA medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WakeMed</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trihealth- Good Samaritan &amp; Bethesda North Hospitals</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Elizabeth Youngstown Hospital</name>
      <address>
        <city>Youngstown</city>
        <state>Ohio</state>
        <zip>44501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Salem Health</name>
      <address>
        <city>Salem</city>
        <state>Oregon</state>
        <zip>97301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn Presbyterian Medical Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Presbyterian</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pinnacle Health Cardiovascular Institute</name>
      <address>
        <city>Wormleysburg</city>
        <state>Pennsylvania</state>
        <zip>17043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Berk Cardiologists</name>
      <address>
        <city>Wyomissing</city>
        <state>Pennsylvania</state>
        <zip>19610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AnMed Health Clinical Research</name>
      <address>
        <city>Anderson</city>
        <state>South Carolina</state>
        <zip>29621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rapid City Regional Health</name>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>75501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stern Cardiovascular Foundation</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heartplace, PA</name>
      <address>
        <city>Bedford</city>
        <state>Texas</state>
        <zip>76021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brooke Army Medical Center</name>
      <address>
        <city>Fort Sam Houston</city>
        <state>Texas</state>
        <zip>78234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Health</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carient Heart and Vascular</name>
      <address>
        <city>Manassas</city>
        <state>Virginia</state>
        <zip>20109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sentara Norfolk General</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Mary's Medical Center</name>
      <address>
        <city>Huntington</city>
        <state>West Virginia</state>
        <zip>25702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <results_first_submitted>December 7, 2021</results_first_submitted>
  <results_first_submitted_qc>December 7, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">January 3, 2022</results_first_posted>
  <last_update_submitted>December 7, 2021</last_update_submitted>
  <last_update_submitted_qc>December 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pacing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ventricular Dysfunction</mesh_term>
    <mesh_term>Ventricular Dysfunction, Left</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>November 15, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT03257436/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Single Arm</title>
          <description>General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use.&#xD;
CRT-D: Left Ventricular MultiSite Pacing</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="584"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="489"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="95"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="76"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Total subjects with non-missing values</population>
      <group_list>
        <group group_id="B1">
          <title>Single Arm</title>
          <description>General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use.&#xD;
CRT-D: Left Ventricular MultiSite Pacing</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="583"/>
          </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="66.7" spread="11"/>
                  </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="211"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="372"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="95"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="460"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="583"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>LV MSP Feature Related Complication-Free Rate</title>
        <description>Proportion of subjects free from LVMSP feature related complications at 12 months</description>
        <time_frame>Between 6 month visit and the 12 month visit in non-responders with LV MSP on for any duration.</time_frame>
        <population>Subjects who are non-responders at the 6 month follow up and who have LVMSP enabled for for any duration between the 6th and 12 month visit</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use.&#xD;
CRT-D: Left Ventricular MultiSite Pacing</description>
          </group>
        </group_list>
        <measure>
          <title>LV MSP Feature Related Complication-Free Rate</title>
          <description>Proportion of subjects free from LVMSP feature related complications at 12 months</description>
          <population>Subjects who are non-responders at the 6 month follow up and who have LVMSP enabled for for any duration between the 6th and 12 month visit</population>
          <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="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99" lower_limit="94.1" upper_limit="NA">As prespecified in the study protocol the lower one-sided 95% confidence bound of the Kaplan-Meier estimate was compared to the performance goal (i.e., only the lower one-side confidence bound was necessary/utilized for hypothesis testing).</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The LV MSP feature-related CFR between the 6 Month Visit and the 12 Month Visit was calculated using Kaplan-Meier methodology.&#xD;
H0: LV MSP feature-related complication-free rate between 6 Month Visit and 12 Month Visit ≤ 90%.&#xD;
The sample size of 61 subjects was required to evaluate the Primary Safety Endpoint using an exact test since a power calculation cannot be directly calculated for a one group Kaplan-Meier analysis.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>A power calculation using a sample size of 61 subjects as the non-responders with the LV MSP on was calculated based on a one-sided exact test for a single binomial proportion, using SAS Version 9.4 with the following assumptions:&#xD;
Performance goal = 90%&#xD;
Expected LV MSP feature-related CFR rate between 6 and 12 Month Visit = 98%&#xD;
Significance level = 5%&#xD;
Power = 80%</non_inferiority_desc>
            <param_type>Kaplan Meir Methodology</param_type>
            <param_value>99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_lower_limit>94.1</ci_lower_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Proportion of LV MSP Group Subjects With an Improved Clinical Composite Score at 12 Months</title>
        <description>Proportion of non-responders with LV MSP enabled at 6 months who were responders at 12 months. Responders were defined as having an Improved Clinical Composite Score at 12 Months.</description>
        <time_frame>12 Month Follow Up</time_frame>
        <population>Non-responders at 6 Months who had LV MSP enabled and had complete clinical composite score data, LV MSP on and achieved &gt;93% LVa and LVb pacing</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use.&#xD;
CRT-D: Left Ventricular MultiSite Pacing</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of LV MSP Group Subjects With an Improved Clinical Composite Score at 12 Months</title>
          <description>Proportion of non-responders with LV MSP enabled at 6 months who were responders at 12 months. Responders were defined as having an Improved Clinical Composite Score at 12 Months.</description>
          <population>Non-responders at 6 Months who had LV MSP enabled and had complete clinical composite score data, LV MSP on and achieved &gt;93% LVa and LVb pacing</population>
          <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="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.3" lower_limit="41.4" upper_limit="NA">The 95% one-sided lower pointwise confidence limit of the response rate was calculated using the one-sided exact methodology for a single binomial proportion and compared to the performance goal of 5%.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The effectiveness endpoint for SMART MSP PAS is the proportion of the LV MSP Group with an Improved CCS. For this endpoint, those subjects in the LV MSP Group that become responders will be defined as having an Improved CCS.&#xD;
H0: Proportion of LV MSP Group subjects with Improved CCS from 6 Month Visit through 12 Month Visit ≤ 5%</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Even though fewer subjects (78) were available for the effectiveness endpoint analysis than originally planned (110), the study was still powered at approximately 90%</non_inferiority_desc>
            <param_type>Proportion</param_type>
            <param_value>51.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_lower_limit>41.1</ci_lower_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected from enrollment until the time the subject's participation ended. Subjects were considered to have completed the study after 12 months of follow up.</time_frame>
      <desc>Reportable adverse events included the following; All Serious Adverse Events, All Heart Failure and Cardiac related Adverse Events requiring IV or invasive therapy, including new onset of cardiac events, or worsening in severity or frequency of preexisting condition, All Adverse Device Effects, All Device Deficiencies, All Adverse Events relate to the protocol required testing, excluding PNS during lead testing ad Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects.</desc>
      <group_list>
        <group group_id="E1">
          <title>Single Arm</title>
          <description>General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use.</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="19" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="131" subjects_at_risk="584"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hematological</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="584"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial Fibrillation (AF)</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Atrial Tachycardia/Other SVT (eg AVRT, AVNRT, EAT)</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Cardiogenic shock</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Chest pain - Heart failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Dyspnea - Heart failure</sub_title>
                <counts group_id="E1" events="22" subjects_affected="15" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Gastrointestinal - Heart failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Incessant VT/VT Storm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Mitral regurgitation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Multi-system failure - Heart failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Multiple Ventricular Arrhythmias</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Multiple heart failure symptoms</sub_title>
                <counts group_id="E1" events="28" subjects_affected="22" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Other - Heart failure patient condition- Cardiovascular</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Other - Patient condition - Cardiovascular</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Pericardial effusion - Unrelated (non study) procedure or device</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Pulmonary edema - Heart failure</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Renal insufficiency/failure - Heart failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Valvular damage/Valvular insufficiency</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Ventricular Fibrillation (VF)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Ventricular Tachycardia (VT)/Monomorphic VT</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Weight gain - Heart failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Atrial (Type 1) Flutter</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Endocrine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Heart failure symptoms - Unspecified</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="584"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="584"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest Pain - Other</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Fatigue and Weakness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>HEENT</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Multi-System Failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Other-Patient Condition-Non-Cardiovascular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Physical Trauma</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="584"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Fever and/or Virus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Infection (&gt;30 days post-implant) - PG System - Subject related</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Localized Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Systemic Infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="584"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Hematoma - Pocket (&lt;=30 days post-implant)</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Post-surgical infection (&lt;=30 days post-implant)</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Seroma - Pocket (&lt;=30 days post-implant)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="584"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Cancer</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="584"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Neurological</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="584"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Dislodgement - LV</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Dislodgement - RA</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Dislodgement - RV</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Erosion - PG System - Subject related</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Inappropriate Tachy Therapy - SVT - PG System Therapy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Inappropriate tachy therapy - SVT - Defibrillation lead</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="584"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Genitourinary</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Renal</sub_title>
                <counts group_id="E1" events="16" subjects_affected="14" subjects_at_risk="584"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>COPD exacerbation</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Pulmonary</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="584"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Integumentary</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular Accident (CVA) - unspecifed</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Coronary Artery Disease</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Hematoma - Unrelated (non study) procedure or device</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Hypotension/Orthostatic Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Myocardial Infacrtion</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Pseudoaneurysm with hematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="584"/>
              </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="72" subjects_at_risk="584"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Premature Atrial Contraction (PAC)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Premature Ventricular Contractions (PVC)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Ventricular Fibrillation (VF)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Ventricular Tachycardia (VT)/Monomorphic VT</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Weight gain - Heart failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="584"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal laboratory values</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Adverse reaction - Medication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Chest pain - Other</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Head, eyes, ears, nose, throat (HEENT)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Multiple symptoms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Other - Patient condition- Non-cardiovascular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Physical trauma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Localized Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Hematoma - Pocket (&lt;=30 days post-implant)</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Post-surgical infection (&lt;=30 days post-implant)</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Post-surgical wound discomfort/bruising/swelling</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Thromboembolic events</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="584"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Dislodgment - RA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Elevated threshold - LV Lead</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Extracardiac stimulation - LV Lead</sub_title>
                <counts group_id="E1" events="22" subjects_affected="21" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Extracardiac stimulation - RV Lead</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Inappropriate tachy therapy - NSR -Defibrillation lead</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Inappropriate tachy therapy - SVT - Defibrillation lead</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Pacemaker Mediated Tachycardia - PG System Therapy</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="584"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Genitourinary</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="584"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Integumentary</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Arterial/venous thrombolytic event</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Chest pain - Ischemic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Hypotension/Orthostatic Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </event>
              <event>
                <sub_title>Peripheral vascular disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="584"/>
              </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>
    <limitations_and_caveats>Because the study was not designed to randomize subjects to conventional CRT or LV MSP, the potential incremental benefit of LV MSP cannot be quantified.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Sharda Mehta</name_or_title>
      <organization>BostonScientific</organization>
      <phone>6785967330</phone>
      <email>sharda.mehta@bsci.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/NCT03257436
org study id: 92050975
nct id: NCT03257436
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Prospective, multi-center, single arm, post approval study to be conducted in the United
      States.
Evaluate the effectiveness of Boston Scientific (BSC)'s LV MSP (Left Ventricular MultiSite
      Pacing) feature in the Resonate family of CRT-D devices and confirm safety in a post approval
      study when used in accordance with its approved labeling.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: LV MSP Feature Related Complication-Free Rate
time frame: Between 6 month visit and the 12 month visit in non-responders with LV MSP on for any duration.
description: Proportion of subjects free from LVMSP feature related complications at 12 months
measure: Proportion of LV MSP Group Subjects With an Improved Clinical Composite Score at 12 Months
time frame: 12 Month Follow Up
description: Proportion of non-responders with LV MSP enabled at 6 months who were responders at 12 months. Responders were defined as having an Improved Clinical Composite Score at 12 Months.
arm group label: Single Arm
arm group type: Other
description: General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use.
intervention type: Device
intervention name: CRT-D
description: Left Ventricular MultiSite Pacing
arm group label: Single Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Saba Samir
role: Principal Investigator
affiliation: University of Pittsburgh Medical Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Ventricular Dysfunction
mesh term: Ventricular Dysfunction, Left
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Because the study was not designed to randomize subjects to conventional CRT or LV MSP, the potential incremental benefit of LV MSP cannot be quantified.
point of contact: 