<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/NCT02232984</url>
  </required_header>
  <id_info>
    <org_study_id>CROSSX4</org_study_id>
    <nct_id>NCT02232984</nct_id>
  </id_info>
  <brief_title>Quadripolar CRT-D On Currently Approved Lead SystemS</brief_title>
  <acronym>CROSS X4</acronym>
  <official_title>Quadripolar CRT-D On Currently Approved Lead SystemS</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>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate different ways to program around extracardiac&#xD;
      stimulation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Vectors With Phrenic Nerve Stimulation (PNS)</measure>
    <time_frame>Pre-discharge (up to 7 days post implant)</time_frame>
    <description>The primary objective of this study was to characterize the performance of Boston Scientific (BSC) unique pacing vectors vs. BSC/St Jude Medical (STJ) common pacing vectors to prevent phrenic nerve stimulation (PNS) based on the selected pacing cathode. BSC unique vectors are those that are only available with Boston Scientific's (BSC) quadripolar (X4) CRT-Ds while common vectors are those that are available for both BSC and STJ systems.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Final Pacing Treshold at Pre-discharge</measure>
    <time_frame>Pre-discharge (up to 7 days post implant)</time_frame>
    <description>Characterize the electrical performance of BSC pacing vectors using pacing thresholds. Summary statistics for LV Tip1 to LV Ring 2 pacing thresholds for the BSC pacing vectors were reported. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Final LV Lead Impedance at Pre-discharge</measure>
    <time_frame>Pre-discharge (up to 7 days post implant)</time_frame>
    <description>Characterize the electrical performance of BSC pacing vectors using impedance measurements. Summary Statistics Were Provided for LV Tip 1 to LV Ring 2 Measurements. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Final Sensing Amplitude at Pre-discharge</measure>
    <time_frame>Pre-discharge (up to 7 days post implant)</time_frame>
    <description>Characterize the electrical performance of BSC pacing vectors using sensing amplitudes. Summary statistics were provided for LV Tip 1 to LV Ring 2 measurements. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems</measure>
    <time_frame>At time of implantation (0 to 30 days post consent signature)</time_frame>
    <description>Characterize the performance of the BSC ACUITY Pro delivery system versus competitive delivery systems in the placement of LV leads. Data collected on the use of the ACUITY Pro delivery system and competitive systems were characterized by presenting summary statistics by system (all competitive devices maybe combined for purposes of reporting), and differences between the ACUITY Pro system and competitive systems were reported as appropriate.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">749</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>All study patients</arm_group_label>
    <description>All study patients will be implanted with a Boston Scientific (BSC) quadripolar Cardiac Resynchronization Therapy (CRT-D) and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors will be tested in order to assess their respective performance.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be selected from the center's general population who are indicated for a&#xD;
        CRT-D. All study subjects will be implanted with the BSC DYNAGEN or INOGEN X4 CRT-D (or any&#xD;
        future FDA approved BSC X4 CRT-D). Subjects may have a previously implanted/will be&#xD;
        receiving an approved quadripolar left ventricular lead.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is medically indicated for implantation with a Boston Scientific (BSC) DYNAGEN&#xD;
             or INOGEN X4 CRT-D (or any future FDA approved BSC X4 CRT-D) and already implanted&#xD;
             with/scheduled to receive a commercially available quadripolar left ventricular lead&#xD;
&#xD;
          -  Subject is willing and capable of providing informed consent and participating in all&#xD;
             testing and study visits associated with this investigation at an approved center and&#xD;
             at the intervals defined by this protocol&#xD;
&#xD;
          -  Subject is age 18 or above, or of legal age to give informed consent specific to state&#xD;
             and national law&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has a known or suspected sensitivity to dexamethasone acetate (DXA)&#xD;
&#xD;
          -  Subject is enrolled in any other concurrent study, without prior approval from BSC&#xD;
&#xD;
          -  Women of childbearing potential who are or might be pregnant at the time of study&#xD;
             enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christopher R Ellis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center, Nashville, TN</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mercy Gilbert Medical Center</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85297</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Phoenix Cardiovascular Research Group/ Heart &amp; Vascular Center of Arizona</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph's Hospital</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yuma Regional Medical Center</name>
      <address>
        <city>Yuma</city>
        <state>Arizona</state>
        <zip>85364</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Associates of Northeast Arkansas</name>
      <address>
        <city>Jonesboro</city>
        <state>Arkansas</state>
        <zip>72401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Arkansas Veterans Healthcare System</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cardiovascular Medical Group</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiac Device Rhythm Specialists, Inc</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Desert Heart Rhythm</name>
      <address>
        <city>Palm Springs</city>
        <state>California</state>
        <zip>92262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bradenton Cardiology Center</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Florida Regional Medical Center</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Florida VA</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeast Cardiology Clinic</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Watson Center Clinic for Research</name>
      <address>
        <city>Lakeland</city>
        <state>Florida</state>
        <zip>33805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charlotte Heart</name>
      <address>
        <city>Port Charlotte</city>
        <state>Florida</state>
        <zip>33952</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brevard Cardiovascular Res. Associates</name>
      <address>
        <city>Rockledge</city>
        <state>Florida</state>
        <zip>32955</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northside Hospital</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33709</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Florida Regional</name>
      <address>
        <city>Sanford</city>
        <state>Florida</state>
        <zip>32771</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarasota Memorial Hosptial</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tallahassee Memorial</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Heart Specialist</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AnMed Health</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>29621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Georgia Heart Foundation</name>
      <address>
        <city>Gainesville</city>
        <state>Georgia</state>
        <zip>30501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeast Georgia Medical Center</name>
      <address>
        <city>Gainesville</city>
        <state>Georgia</state>
        <zip>30501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Suburban Hospital</name>
      <address>
        <city>Oak Park</city>
        <state>Illinois</state>
        <zip>60302</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central DuPage Medical Center</name>
      <address>
        <city>Winfield</city>
        <state>Illinois</state>
        <zip>60190</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lutheran Hospital</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkview Hospital</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46843</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Hospital</name>
      <address>
        <city>Munster</city>
        <state>Indiana</state>
        <zip>46321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Health Lexington</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ark-La-Tex Cardiology, APMC</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Willis Knighton</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. John Hospital and Medical Center</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hurley Hospital</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48532</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Genesys Medical Center</name>
      <address>
        <city>Grand Blanc</city>
        <state>Michigan</state>
        <zip>48439</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegiance Health</name>
      <address>
        <city>Jackson</city>
        <state>Michigan</state>
        <zip>49201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lakeland Medical Center</name>
      <address>
        <city>Saint Joseph</city>
        <state>Michigan</state>
        <zip>49085</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HealthEast St. Joseph's Hospital</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Desert Springs</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Catholic Medical Center</name>
      <address>
        <city>Manchester</city>
        <state>New Hampshire</state>
        <zip>03102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanticare Regional Medical Center</name>
      <address>
        <city>Atlantic City</city>
        <state>New Jersey</state>
        <zip>08401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital/ Buffalo Heart Group</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Genesis Health System</name>
      <address>
        <city>Zanesville</city>
        <state>Ohio</state>
        <zip>43701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bryn Mawr Hospital</name>
      <address>
        <city>Bryn Mawr</city>
        <state>Pennsylvania</state>
        <zip>19010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercer Bucks Cardiology</name>
      <address>
        <city>Newtown</city>
        <state>Pennsylvania</state>
        <zip>18940</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Hospital of Scranton</name>
      <address>
        <city>Scranton</city>
        <state>Pennsylvania</state>
        <zip>18510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Core CV Research</name>
      <address>
        <city>Jackson</city>
        <state>Tennessee</state>
        <zip>38305</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>Houston Arrhythmia Associates</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Cardiovascular Associates</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart Institute of East Texas</name>
      <address>
        <city>Lufkin</city>
        <state>Texas</state>
        <zip>75904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Woodlands North Houston Heart Ctr</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>17350</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Vermont Medical Center</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hunter Holmes VA Medical Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Mason Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Belin Healthcare</name>
      <address>
        <city>Green Bay</city>
        <state>Wisconsin</state>
        <zip>54301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <results_first_submitted>March 31, 2017</results_first_submitted>
  <results_first_submitted_qc>October 2, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">February 18, 2019</results_first_posted>
  <last_update_submitted>April 1, 2019</last_update_submitted>
  <last_update_submitted_qc>April 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Heart Failure</keyword>
  <keyword>Cardiac Resynchronization Therapy (CRT)</keyword>
  <keyword>CRT-D</keyword>
  <keyword>Quadripolar pacing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 749 subjects were enrolled. Of these, 7 did not complete baseline demographics due to early withdrawals and 1 additional was withdrawn due to LV lead not placed. Therefore, baseline demographics is based on a maximum of 742 subjects.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>All Study Patients</title>
          <description>All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were tested in order to assess their respective performance.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="749">Enrolled subjects</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Successfully Implanted</title>
              <participants_list>
                <participants group_id="P1" count="675">Successfully implanted subjects</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="672">Total number of subjects who completed study</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="77"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Investigator withdrawal</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Device implant unsuccessful</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>not disclosed by site</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Of the 749 enrolled subjects, 742 subjects provided baseline demographics information. Six were early withdrawals and one additional was not implanted with LV lead.</population>
      <group_list>
        <group group_id="B1">
          <title>All Study Patients</title>
          <description>All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were tested in order to assess their respective performance.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="742"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="742"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.2" spread="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="742"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="180"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="562"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="742"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="742"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Left Ventricular Ejection Fraction (LVEF) %</title>
          <population>Number of subjects with this baseline characteristic is smaller than overall population because this information was not collected/provided by the centers for all patients.</population>
          <units>%</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="738"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.5" spread="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>QRS width</title>
          <population>Number of subjects with this baseline characteristic is smaller than overall population because this information was not collected/provided by the centers for all patients.</population>
          <units>ms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="736"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="153.7" spread="28.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Vectors With Phrenic Nerve Stimulation (PNS)</title>
        <description>The primary objective of this study was to characterize the performance of Boston Scientific (BSC) unique pacing vectors vs. BSC/St Jude Medical (STJ) common pacing vectors to prevent phrenic nerve stimulation (PNS) based on the selected pacing cathode. BSC unique vectors are those that are only available with Boston Scientific's (BSC) quadripolar (X4) CRT-Ds while common vectors are those that are available for both BSC and STJ systems.</description>
        <time_frame>Pre-discharge (up to 7 days post implant)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Study Patients</title>
            <description>All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were tested in order to assess their respective performance.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Vectors With Phrenic Nerve Stimulation (PNS)</title>
          <description>The primary objective of this study was to characterize the performance of Boston Scientific (BSC) unique pacing vectors vs. BSC/St Jude Medical (STJ) common pacing vectors to prevent phrenic nerve stimulation (PNS) based on the selected pacing cathode. BSC unique vectors are those that are only available with Boston Scientific's (BSC) quadripolar (X4) CRT-Ds while common vectors are those that are available for both BSC and STJ systems.</description>
          <units>Number of Pacing vectors with PNS</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="672"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Unique pacing vectors with PNS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="181"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Common vectors with PNS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="189"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Final Pacing Treshold at Pre-discharge</title>
        <description>Characterize the electrical performance of BSC pacing vectors using pacing thresholds. Summary statistics for LV Tip1 to LV Ring 2 pacing thresholds for the BSC pacing vectors were reported. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.</description>
        <time_frame>Pre-discharge (up to 7 days post implant)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Study Patients</title>
            <description>All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were tested in order to assess their respective performance.</description>
          </group>
        </group_list>
        <measure>
          <title>Final Pacing Treshold at Pre-discharge</title>
          <description>Characterize the electrical performance of BSC pacing vectors using pacing thresholds. Summary statistics for LV Tip1 to LV Ring 2 pacing thresholds for the BSC pacing vectors were reported. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.</description>
          <units>Volts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="672"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.93" spread="1.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Final LV Lead Impedance at Pre-discharge</title>
        <description>Characterize the electrical performance of BSC pacing vectors using impedance measurements. Summary Statistics Were Provided for LV Tip 1 to LV Ring 2 Measurements. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.</description>
        <time_frame>Pre-discharge (up to 7 days post implant)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Study Patients</title>
            <description>All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were be tested in order to assess their respective performance. Performance of the LV lead delivery system (Acuity Pro vs other LV delivery systems) were assessed. Although use of Acuity Pro was recommended, choice of delivery system was at the physician's discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Final LV Lead Impedance at Pre-discharge</title>
          <description>Characterize the electrical performance of BSC pacing vectors using impedance measurements. Summary Statistics Were Provided for LV Tip 1 to LV Ring 2 Measurements. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.</description>
          <units>Ohms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="672"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1034.7" spread="310.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Final Sensing Amplitude at Pre-discharge</title>
        <description>Characterize the electrical performance of BSC pacing vectors using sensing amplitudes. Summary statistics were provided for LV Tip 1 to LV Ring 2 measurements. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.</description>
        <time_frame>Pre-discharge (up to 7 days post implant)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Study Patients</title>
            <description>All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were be tested in order to assess their respective performance. Performance of the LV lead delivery system (Acuity Pro vs other LV delivery systems) were assessed. Although use of Acuity Pro was recommended, choice of delivery system was at the physician's discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Final Sensing Amplitude at Pre-discharge</title>
          <description>Characterize the electrical performance of BSC pacing vectors using sensing amplitudes. Summary statistics were provided for LV Tip 1 to LV Ring 2 measurements. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.</description>
          <units>Milivolts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="672"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.30" spread="6.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems</title>
        <description>Characterize the performance of the BSC ACUITY Pro delivery system versus competitive delivery systems in the placement of LV leads. Data collected on the use of the ACUITY Pro delivery system and competitive systems were characterized by presenting summary statistics by system (all competitive devices maybe combined for purposes of reporting), and differences between the ACUITY Pro system and competitive systems were reported as appropriate.</description>
        <time_frame>At time of implantation (0 to 30 days post consent signature)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Acuity Pro LV Lead Delivery System</title>
            <description>All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were be tested in order to assess their respective performance. Performance of the LV lead delivery system (Acuity Pro vs other LV delivery systems) were assessed. Although use of Acuity Pro was recommended, choice of delivery system was at the physician's discretion.</description>
          </group>
          <group group_id="O2">
            <title>Other LV Lead Delivery Systems</title>
            <description>All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors will be tested in order to assess their respective performance. Performance of the LV lead delivery system (Acuity Pro vs other LV delivery systems) was assessed. Although use of Acuity Pro was recommended, choice of delivery system was at the physician's discretion.</description>
          </group>
        </group_list>
        <measure>
          <title>Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems</title>
          <description>Characterize the performance of the BSC ACUITY Pro delivery system versus competitive delivery systems in the placement of LV leads. Data collected on the use of the ACUITY Pro delivery system and competitive systems were characterized by presenting summary statistics by system (all competitive devices maybe combined for purposes of reporting), and differences between the ACUITY Pro system and competitive systems were reported as appropriate.</description>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="394"/>
                <count group_id="O2" value="281"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Skin to skin time (min)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.4" spread="38.9"/>
                    <measurement group_id="O2" value="87.8" spread="38.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lead placement time (min)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.5" spread="23.5"/>
                    <measurement group_id="O2" value="29.8" spread="24.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CS Canulation Time (min)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2" spread="9.4"/>
                    <measurement group_id="O2" value="7.8" spread="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall catheter in the body time (min)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.9" spread="21.8"/>
                    <measurement group_id="O2" value="32.7" spread="25.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From enrollment through pre-discharge (up to 7 days post-implant). Study was completed at pre-discharge.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>All Study Patients</title>
          <description>All study patients were implanted with a BSC quadripolar CRT-D and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors were be tested in order to assess their respective performance.</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="1" subjects_at_risk="749"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="749"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Inadvertent VT/VF</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="749"/>
              </event>
              <event>
                <sub_title>Dislodgement - undersensing RV</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="749"/>
              </event>
              <event>
                <sub_title>Dislodgement - no reported signs - RA</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="749"/>
              </event>
              <event>
                <sub_title>Elevated threshold - RV</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="749"/>
              </event>
              <event>
                <sub_title>Dislodgment - no reported signs - LV</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="749"/>
              </event>
              <event>
                <sub_title>Dislodgment - no reported signs - RV</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="749"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Adverse reaction - general</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="749"/>
              </event>
              <event>
                <sub_title>Adverse drug reaction - respiratory</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="749"/>
              </event>
              <event>
                <sub_title>Hematoma pocket &lt;= 30 days</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="749"/>
              </event>
              <event>
                <sub_title>Coronary venous dissection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="749"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0.5</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="11" subjects_at_risk="749"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Dislodgement - no reported signs - RA</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="749"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Coronary Venous dissection</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="749"/>
              </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>Eszter Pais</name_or_title>
      <organization>Boston Scientific</organization>
      <phone>6515825307</phone>
      <email>eszter.pais@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/NCT02232984
org study id: CROSSX4
nct id: NCT02232984
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to evaluate different ways to program around extracardiac
      stimulation.
observational model: Cohort
time perspective: Prospective
measure: Number of Vectors With Phrenic Nerve Stimulation (PNS)
time frame: Pre-discharge (up to 7 days post implant)
description: The primary objective of this study was to characterize the performance of Boston Scientific (BSC) unique pacing vectors vs. BSC/St Jude Medical (STJ) common pacing vectors to prevent phrenic nerve stimulation (PNS) based on the selected pacing cathode. BSC unique vectors are those that are only available with Boston Scientific's (BSC) quadripolar (X4) CRT-Ds while common vectors are those that are available for both BSC and STJ systems.
measure: Final Pacing Treshold at Pre-discharge
time frame: Pre-discharge (up to 7 days post implant)
description: Characterize the electrical performance of BSC pacing vectors using pacing thresholds. Summary statistics for LV Tip1 to LV Ring 2 pacing thresholds for the BSC pacing vectors were reported. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.
measure: Final LV Lead Impedance at Pre-discharge
time frame: Pre-discharge (up to 7 days post implant)
description: Characterize the electrical performance of BSC pacing vectors using impedance measurements. Summary Statistics Were Provided for LV Tip 1 to LV Ring 2 Measurements. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.
measure: Final Sensing Amplitude at Pre-discharge
time frame: Pre-discharge (up to 7 days post implant)
description: Characterize the electrical performance of BSC pacing vectors using sensing amplitudes. Summary statistics were provided for LV Tip 1 to LV Ring 2 measurements. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.
measure: Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems
time frame: At time of implantation (0 to 30 days post consent signature)
description: Characterize the performance of the BSC ACUITY Pro delivery system versus competitive delivery systems in the placement of LV leads. Data collected on the use of the ACUITY Pro delivery system and competitive systems were characterized by presenting summary statistics by system (all competitive devices maybe combined for purposes of reporting), and differences between the ACUITY Pro system and competitive systems were reported as appropriate.
arm group label: All study patients
description: All study patients will be implanted with a Boston Scientific (BSC) quadripolar Cardiac Resynchronization Therapy (CRT-D) and a currently approved quadripolar left ventricular lead. At the pre-discharge visit, multiple vectors will be tested in order to assess their respective performance.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christopher R Ellis, MD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center, Nashville, TN
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country: United States
responsible party type: Sponsor
mesh term: Heart Failure
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