<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/NCT01688843</url>
  </required_header>
  <id_info>
    <org_study_id>BSC-CDM00048360</org_study_id>
    <nct_id>NCT01688843</nct_id>
  </id_info>
  <brief_title>Safety and Performance Study of the INGEVITY Lead</brief_title>
  <official_title>INGEVITY(TM) Active Fixation and Passive Fixation Pace/ Sense Lead Clinical Study</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>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to gather data to establish the safety, performance and&#xD;
      effectiveness of the INGEVITY pace/ sense leads.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to gather data to establish the safety, performance and&#xD;
      effectiveness of the INGEVITY pace/ sense leads&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">February 2019</completion_date>
  <primary_completion_date type="Actual">January 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety 1 - Percentage of Leads Free From Complication (0 - 3 Months)</measure>
    <time_frame>Lead implant through 3 month follow up</time_frame>
    <description>Lead-related complication-free rate from lead implant through the three month follow-up, based on complications that are related to the INGEVITY Lead. The performance goal based on similar leads was set in collaboration with FDA at 91.4%</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety 2 - Percentage of Leads Free From Complication (3 - 24 Months)</measure>
    <time_frame>3 months through 12 months post implant</time_frame>
    <description>Lead-related complication-free rate from three months post-implant through twelve months post implant, based on complications that are related to the INGEVITY Lead. The performance goal based on similar leads was set in collaboration with FDA at 94%.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety 3 - Hazard Rate of Lead-Related Complications</measure>
    <time_frame>Implant through 12 months (including available data beyond 12 months)</time_frame>
    <description>Hazard rate of lead-related complications over time. This endpoint will use the Weibull distribution to estimate the hazard over time by evaluating the Weibull shape parameter. A Weibull shape greater than one (&gt;1), equal to one (=1) and less than one (&lt;1) indicates accelerating, constant, and decelerating hazard of lead-related complications over time, respectively. This endpoint requires the Weibull shape estimate to be less than 1.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effectiveness 1</measure>
    <time_frame>Lead implant through 3 month follow up</time_frame>
    <description>The bipolar pacing threshold at 0.5 ms at three months post-implant &lt; 1.5 V</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effectiveness 2(Right Atrium)</measure>
    <time_frame>Lead implant through 3 month follow up</time_frame>
    <description>P-wave sensed amplitude at three months post-implant &gt; 1.5 mV</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effectiveness 2(Right Ventricle)</measure>
    <time_frame>Lead implant through 3 month follow up</time_frame>
    <description>R-wave sensed amplitude at three months post-implant &gt; 5 mV</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effectiveness 3</measure>
    <time_frame>Lead implant through 3 month follow up</time_frame>
    <description>Clinically acceptable pacing impedance between 300 Ω and 1300 Ω</description>
  </primary_outcome>
  <other_outcome>
    <measure>Ancillary Safety</measure>
    <time_frame>From 3 to 60 months post-implant</time_frame>
    <description>Lead-related complication-free rate</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1060</enrollment>
  <condition>Bradycardia</condition>
  <condition>Sinus Node Dysfunction</condition>
  <arm_group>
    <arm_group_label>INGEVITY lead</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>INGEVITY lead implant</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>INGEVITY lead</intervention_name>
    <arm_group_label>INGEVITY lead</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is willing and capable of providing informed consent&#xD;
&#xD;
          -  Subject has a Class I or II indication for implantation of a single(VVI (R) only) or&#xD;
             dual chamber pacemaker or a CRT-P system according to the ACC/AHA/HRS, or ESC&#xD;
             guidelines&#xD;
&#xD;
          -  Subject is willing and capable of participating in all testing/ visits associated with&#xD;
             this clinical study at an approved clinical study center and at the intervals defined&#xD;
             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 or has had any pacing or ICD system implants&#xD;
&#xD;
          -  Subject has a sensitivity to dexamethasone acetate (DXA)&#xD;
&#xD;
          -  Subject has a mechanical tricuspid heart valve&#xD;
&#xD;
          -  Subject is enrolled in any other concurrent study, with the exception of local&#xD;
             mandatory governmental registries and observational studies/registries&#xD;
&#xD;
          -  Subjects with documented permanent or persistent AF where the physician intends to&#xD;
             implant dual chamber pulse generator (single chamber VVIR pulse generators in these&#xD;
             subjects is acceptable)&#xD;
&#xD;
          -  Subject is currently on the active heart transplant list&#xD;
&#xD;
          -  Subject has documented life expectancy of less than 12 months&#xD;
&#xD;
          -  Women of childbearing potential who are or might be pregnant at the time of study&#xD;
             enrollment or INGEVITY Lead implant&#xD;
&#xD;
          -  Subjects currently requiring dialysis&#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>Charles Love, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</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>Cardiovascular Consultants, LTD</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pima Heart Physicians, PC</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sharp Grossmont Hospital</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orange County Heart Institute</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisenhower Medical Center</name>
      <address>
        <city>Rancho Mirage</city>
        <state>California</state>
        <zip>92270-3221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sharp Memorial Hospital</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Danbury Hospital</name>
      <address>
        <city>Danbury</city>
        <state>Connecticut</state>
        <zip>06810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Associates of Fairfield County</name>
      <address>
        <city>Trumbull</city>
        <state>Connecticut</state>
        <zip>06611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Florida Cardiology Network, LLC</name>
      <address>
        <city>Largo</city>
        <state>Florida</state>
        <zip>33770</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Community Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellstar Research Institute</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent's Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University Health La Porte Hospital</name>
      <address>
        <city>LaPorte</city>
        <state>Indiana</state>
        <zip>46350</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Kentucky Heart Institute</name>
      <address>
        <city>Bowling Green</city>
        <state>Kentucky</state>
        <zip>42101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Clinic Foundation</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan CardioVascular Institute</name>
      <address>
        <city>Saginaw</city>
        <state>Michigan</state>
        <zip>48601</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>Cardiovascular Associates of the Delaware Valley</name>
      <address>
        <city>Sewell</city>
        <state>New Jersey</state>
        <zip>08080</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Methodist Hospital</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rochester General Hospital</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Staten Island University Hospital</name>
      <address>
        <city>Staten Island</city>
        <state>New York</state>
        <zip>10309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Forsyth Medical Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aultman Hospital</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lindner Center for Research and Education at Christ Hosp</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital, Inc.</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Ohio Cardiology Consultants</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Cardiology</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spartanburg Regional Medical Center</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Austin Hospital</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78745</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart Hospital of Austin</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Texas Heart Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Plaza Medical Center of Fort Worth</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trinity Mother Frances Health System</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah Hospital and Clinics</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bon Secours Heart &amp; Vascular Institute</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PeaceHealth St. Joseph Medical Center</name>
      <address>
        <city>Bellingham</city>
        <state>Washington</state>
        <zip>98225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monongalia General Hospital</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wheeling Hospital Inc.</name>
      <address>
        <city>Wheeling</city>
        <state>West Virginia</state>
        <zip>26003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wheaton Franciscan Healthcare</name>
      <address>
        <city>Glendale</city>
        <state>Wisconsin</state>
        <zip>53212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Mary's Madison</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53715</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Andrew's War Memorial Hospital</name>
      <address>
        <city>Brisbane</city>
        <state>Queensland</state>
        <zip>4001</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Prince Charles Hospital</name>
      <address>
        <city>Chermside</city>
        <state>Queensland</state>
        <zip>4032</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Univ.-Kliniken Graz</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AKH Linz</name>
      <address>
        <city>Linz</city>
        <zip>4021</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Wels-Grieskirchen GmbH</name>
      <address>
        <city>Wels</city>
        <zip>4600</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Groeninge Campus</name>
      <address>
        <city>Kortrijk</city>
        <zip>8500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Columbian Hospital</name>
      <address>
        <city>New Westminster</city>
        <state>British Columbia</state>
        <zip>V3L 3W7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamilton General Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8L 2X2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Hotel Dieu du Centre Hospitalier de l'Universite de Montreal</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2W IT7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skejby Sygehus</name>
      <address>
        <city>Aarhus</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Roskilde University Hospital</name>
      <address>
        <city>Roskilde</city>
        <zip>4000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU La Timone Hospital</name>
      <address>
        <city>Marseille Cedex 05</city>
        <zip>13005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NCN Nouvelles Cliniques Nantaises</name>
      <address>
        <city>Nantes Cedex 2</city>
        <zip>44277</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kardiologische Gemeinschaftspraxis Kaltofen Schubert Gerner</name>
      <address>
        <city>Chemnitz</city>
        <zip>09116</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniklinik Köln</name>
      <address>
        <city>Cologne</city>
        <zip>50931</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Erlangen</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Otto-von-Guericke-Universitaet Magdeburg</name>
      <address>
        <city>Magdeburg</city>
        <zip>39120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Shatin</city>
        <zip>999077</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Integrata di Verona</name>
      <address>
        <city>Verona</city>
        <zip>37126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Jantung Negara</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>50400</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Malaya Medical Centre</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>50603</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar do Porto - Hospital de Santo Antonio</name>
      <address>
        <city>Porto</city>
        <zip>4099 - 001</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Santarem</name>
      <address>
        <city>Santarem</city>
        <zip>2005-177</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Y Provincial</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Nuestra Senora de Candelaria</name>
      <address>
        <city>Santa Cruz de Tenerife</city>
        <zip>38010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Doctor Peset</name>
      <address>
        <city>Valencia</city>
        <zip>46017</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinico de Valladolid</name>
      <address>
        <city>Valladolid</city>
        <zip>47012</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sahlgrenska University Hospital</name>
      <address>
        <city>Göteborg</city>
        <zip>41345</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska University Hospital</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiang Mai Heart Center Medical School Hospital</name>
      <address>
        <city>Chiang Mai</city>
        <zip>50200</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Basildon and Thurrock University Hospitals NHS</name>
      <address>
        <city>Basildon</city>
        <state>Essex</state>
        <zip>SS16 5NL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Belfast City Hospital</name>
      <address>
        <city>Belfast</city>
        <zip>BT9 7</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wrexham Maelor Hospital</name>
      <address>
        <city>Wrexham</city>
        <zip>LL13 7TD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hong Kong</country>
    <country>Italy</country>
    <country>Malaysia</country>
    <country>Portugal</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Thailand</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 20, 2012</study_first_posted>
  <results_first_submitted>April 3, 2017</results_first_submitted>
  <results_first_submitted_qc>October 16, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">November 17, 2017</results_first_posted>
  <last_update_submitted>March 2, 2020</last_update_submitted>
  <last_update_submitted_qc>March 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bradycardia</keyword>
  <keyword>sinus node dysfunction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bradycardia</mesh_term>
    <mesh_term>Sick Sinus Syndrome</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>INGEVITY Study Participants</title>
          <description>Each participant was allowed to have up to 2 INGEVITY leads contribute to endpoint analyses -- one per chamber (right atrium and right ventricle). Final lead implanted or attempted during initial procedure per chamber was used for analysis.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1060"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1060"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>INGEVITY Lead</title>
          <description>INGEVITY lead implant</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1060"/>
          </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="74.3" spread="10.6"/>
                  </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="478"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="582"/>
                  </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>Hong Kong</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="603"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaysia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thailand</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Portugal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Austria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sweden</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Denmark</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Safety 1 - Percentage of Leads Free From Complication (0 - 3 Months)</title>
        <description>Lead-related complication-free rate from lead implant through the three month follow-up, based on complications that are related to the INGEVITY Lead. The performance goal based on similar leads was set in collaboration with FDA at 91.4%</description>
        <time_frame>Lead implant through 3 month follow up</time_frame>
        <population>Final lead implanted or attempted during initial procedure per chamber was used for analysis. Analysis leads were from participants who met inclusion/exclusion criteria and were implanted or attempted with INGEVITY lead(s). Of the 1060 enrolled participants, 24 did not meet these criteria and were excluded from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>INGEVITY Lead</title>
            <description>Implanted/Attempted Leads</description>
          </group>
        </group_list>
        <measure>
          <title>Safety 1 - Percentage of Leads Free From Complication (0 - 3 Months)</title>
          <description>Lead-related complication-free rate from lead implant through the three month follow-up, based on complications that are related to the INGEVITY Lead. The performance goal based on similar leads was set in collaboration with FDA at 91.4%</description>
          <population>Final lead implanted or attempted during initial procedure per chamber was used for analysis. Analysis leads were from participants who met inclusion/exclusion criteria and were implanted or attempted with INGEVITY lead(s). Of the 1060 enrolled participants, 24 did not meet these criteria and were excluded from the analysis.</population>
          <units>percentage of leads complication-free</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Implant/Attempted Leads</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1036"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Implant/Attempted Leads</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1599"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.4" lower_limit="97.7" upper_limit="NA">One-sided confidence interval</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Safety 2 - Percentage of Leads Free From Complication (3 - 24 Months)</title>
        <description>Lead-related complication-free rate from three months post-implant through twelve months post implant, based on complications that are related to the INGEVITY Lead. The performance goal based on similar leads was set in collaboration with FDA at 94%.</description>
        <time_frame>3 months through 12 months post implant</time_frame>
        <population>Leads still in service and implanted in actively followed participants at 92 days were included in analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>INGEVITY Lead</title>
            <description>Implanted/Attempted Leads</description>
          </group>
        </group_list>
        <measure>
          <title>Safety 2 - Percentage of Leads Free From Complication (3 - 24 Months)</title>
          <description>Lead-related complication-free rate from three months post-implant through twelve months post implant, based on complications that are related to the INGEVITY Lead. The performance goal based on similar leads was set in collaboration with FDA at 94%.</description>
          <population>Leads still in service and implanted in actively followed participants at 92 days were included in analysis.</population>
          <units>percentage of leads complication-free</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Implant/Attempted Leads</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1009"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Implant/Attempted Leads</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1545"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.7" lower_limit="99.4" upper_limit="NA">One-sided confidence interval</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Safety 3 - Hazard Rate of Lead-Related Complications</title>
        <description>Hazard rate of lead-related complications over time. This endpoint will use the Weibull distribution to estimate the hazard over time by evaluating the Weibull shape parameter. A Weibull shape greater than one (&gt;1), equal to one (=1) and less than one (&lt;1) indicates accelerating, constant, and decelerating hazard of lead-related complications over time, respectively. This endpoint requires the Weibull shape estimate to be less than 1.</description>
        <time_frame>Implant through 12 months (including available data beyond 12 months)</time_frame>
        <population>Final lead implanted or attempted during initial procedure per chamber was used for analysis. Analysis leads were from participants who met inclusion/exclusion criteria and were implanted or attempted with INGEVITY lead(s). Of the 1060 enrolled participants, 24 did not meet these criteria and were excluded from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>INGEVITY Lead</title>
            <description>Implanted/Attempted Leads</description>
          </group>
        </group_list>
        <measure>
          <title>Safety 3 - Hazard Rate of Lead-Related Complications</title>
          <description>Hazard rate of lead-related complications over time. This endpoint will use the Weibull distribution to estimate the hazard over time by evaluating the Weibull shape parameter. A Weibull shape greater than one (&gt;1), equal to one (=1) and less than one (&lt;1) indicates accelerating, constant, and decelerating hazard of lead-related complications over time, respectively. This endpoint requires the Weibull shape estimate to be less than 1.</description>
          <population>Final lead implanted or attempted during initial procedure per chamber was used for analysis. Analysis leads were from participants who met inclusion/exclusion criteria and were implanted or attempted with INGEVITY lead(s). Of the 1060 enrolled participants, 24 did not meet these criteria and were excluded from the analysis.</population>
          <units>hazard rate of lead-related complication</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Leads Implanted/Attempted</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1036"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Leads Implanted/Attempted</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1599"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.23" lower_limit="NA" upper_limit="0.3">One-sided confidence interval</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Effectiveness 1</title>
        <description>The bipolar pacing threshold at 0.5 ms at three months post-implant &lt; 1.5 V</description>
        <time_frame>Lead implant through 3 month follow up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>INGEVITY Lead</title>
            <description>INGEVITY lead implant</description>
          </group>
        </group_list>
        <measure>
          <title>Effectiveness 1</title>
          <description>The bipolar pacing threshold at 0.5 ms at three months post-implant &lt; 1.5 V</description>
          <units>volts</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Implant/Attempted Leads</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="982"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Implant/Attempted Leads</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1482"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.67" lower_limit="0.65" upper_limit="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Effectiveness 2(Right Atrium)</title>
        <description>P-wave sensed amplitude at three months post-implant &gt; 1.5 mV</description>
        <time_frame>Lead implant through 3 month follow up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>INGEVITY Lead</title>
            <description>INGEVITY lead implant</description>
          </group>
        </group_list>
        <measure>
          <title>Effectiveness 2(Right Atrium)</title>
          <description>P-wave sensed amplitude at three months post-implant &gt; 1.5 mV</description>
          <units>mV</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Implant/Attempted Leads</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="521"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Implant/Attempted Leads</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="521"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" lower_limit="4.6" upper_limit="NA">One-sided confidence interval</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Effectiveness 2(Right Ventricle)</title>
        <description>R-wave sensed amplitude at three months post-implant &gt; 5 mV</description>
        <time_frame>Lead implant through 3 month follow up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>INGEVITY Lead</title>
            <description>INGEVITY lead implant</description>
          </group>
        </group_list>
        <measure>
          <title>Effectiveness 2(Right Ventricle)</title>
          <description>R-wave sensed amplitude at three months post-implant &gt; 5 mV</description>
          <units>mV</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Implant/Attempted Leads</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="914"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Implant/Attempted Leads</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="914"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.5" lower_limit="16.2" upper_limit="NA">One-sided confidence interval</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Effectiveness 3</title>
        <description>Clinically acceptable pacing impedance between 300 Ω and 1300 Ω</description>
        <time_frame>Lead implant through 3 month follow up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>INGEVITY Lead</title>
            <description>INGEVITY lead implant</description>
          </group>
        </group_list>
        <measure>
          <title>Effectiveness 3</title>
          <description>Clinically acceptable pacing impedance between 300 Ω and 1300 Ω</description>
          <units>Ω</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Implant/Attempted Leads</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="995"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Implant/Attempted Leads</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1526"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="773" lower_limit="766" upper_limit="779"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Ancillary Safety</title>
        <description>Lead-related complication-free rate</description>
        <time_frame>From 3 to 60 months post-implant</time_frame>
        <population>Leads eligible for endpoint analyses</population>
        <group_list>
          <group group_id="O1">
            <title>INGEVITY Lead</title>
            <description>INGEVITY lead implant&#xD;
INGEVITY lead</description>
          </group>
        </group_list>
        <measure>
          <title>Ancillary Safety</title>
          <description>Lead-related complication-free rate</description>
          <population>Leads eligible for endpoint analyses</population>
          <units>percentage of leads complication-free</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Leads</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1038"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Leads</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1599"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.1" lower_limit="98.6" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Entire follow-up (median participant follow-up = 30.9 months)</time_frame>
      <desc>All-cause mortality evaluated in all enrolled participants (N = 1060). Adverse events evaluated in participants implanted or attempted with at least one INGEVITY lead (N = 1041). Individual adverse event categories evaluated in participants at risk for that event category (e.g., Pulse generator events evaluated in participants with a pulse generator).</desc>
      <group_list>
        <group group_id="E1">
          <title>INGEVITY Study Participants</title>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="93" subjects_at_risk="1060"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="532" subjects_at_risk="1041"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiovascular - Heart Failure</sub_title>
                <counts group_id="E1" events="163" subjects_affected="101" subjects_at_risk="1041"/>
              </event>
              <event>
                <sub_title>Cardiovascular - Non-Heart Failure</sub_title>
                <counts group_id="E1" events="326" subjects_affected="241" subjects_at_risk="1041"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Other</sub_title>
                <counts group_id="E1" events="54" subjects_affected="49" subjects_at_risk="1041"/>
              </event>
              <event>
                <sub_title>Non-cardiovascular</sub_title>
                <counts group_id="E1" events="705" subjects_affected="357" subjects_at_risk="1041"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Unclassified</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="1041"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Pulse Generator</sub_title>
                <description>Includes:&#xD;
Oversensing - Defibrillation Rate response inappropriate Inappropriate AV delay Pacemaker-mediated tachycardia (PMT) Erosion Infection (&gt; 30 days post-implant) Migration</description>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="1041"/>
              </event>
              <event>
                <sub_title>Right Atrial (RA) Lead - INGEVITY Related</sub_title>
                <description>564 patients were attempted/implanted with a INGEVITY RA lead, therefore that is the number at risk for an adverse event</description>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="564"/>
              </event>
              <event>
                <sub_title>RA Lead - Other (Non-INGEVITY Lead)</sub_title>
                <description>858 patients were attempted/implanted with an OTHER (non-INGEVITY) RA lead, therefore that is the number at risk for an adverse event</description>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="858"/>
              </event>
              <event>
                <sub_title>Right Ventricular (RV) Lead - INGEVITY-related</sub_title>
                <description>Includes:&#xD;
Unable to capture - RV - INGEVITY-related Elevated threshold - RV - INGEVITY-related Extracardiac stimulation - RV - INGEVITY-related Conductor coil fracture - RV - INGEVITY-related Dislodgment - RV - INGEVITY-related</description>
                <counts group_id="E1" events="20" subjects_affected="15" subjects_at_risk="1041"/>
              </event>
              <event>
                <sub_title>RV Lead - Other (Non-INGEVITY Lead)</sub_title>
                <description>Includes:&#xD;
Other - RV Lead - Other</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1041"/>
              </event>
              <event>
                <sub_title>Left-Ventricular (LV) Lead</sub_title>
                <description>Includes:&#xD;
Elevated threshold - LV Extracardiac stimulation - LV Dislodgment - LV</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1041"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Procedure</sub_title>
                <counts group_id="E1" events="26" subjects_affected="26" subjects_at_risk="1041"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="621" subjects_at_risk="1041"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiovascular - HF</sub_title>
                <counts group_id="E1" events="74" subjects_affected="61" subjects_at_risk="1041"/>
              </event>
              <event>
                <sub_title>Cardiovascular - Non-HF</sub_title>
                <counts group_id="E1" events="720" subjects_affected="412" subjects_at_risk="1041"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Other</sub_title>
                <counts group_id="E1" events="103" subjects_affected="89" subjects_at_risk="1041"/>
              </event>
              <event>
                <sub_title>Unclassified</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="1041"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Pulse Generator</sub_title>
                <counts group_id="E1" events="37" subjects_affected="32" subjects_at_risk="1041"/>
              </event>
              <event>
                <sub_title>RA Lead - INGEVITY-related</sub_title>
                <description>564 patients were attempted/implanted with an INGEVITY RA lead, therefore that is the number at risk for an adverse event</description>
                <counts group_id="E1" events="17" subjects_affected="16" subjects_at_risk="564"/>
              </event>
              <event>
                <sub_title>RA Lead - Other</sub_title>
                <description>858 patients were attempted/implanted with an OTHER (non-INGEVITY) RA lead, therefore that is the number at risk for an adverse event</description>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="858"/>
              </event>
              <event>
                <sub_title>RV Lead - INGEVITY-related</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="1041"/>
              </event>
              <event>
                <sub_title>LV Lead</sub_title>
                <description>47 patients were attempted/implanted with any LV lead, therefore that is the number at risk for an adverse event</description>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Procedure</sub_title>
                <counts group_id="E1" events="66" subjects_affected="58" subjects_at_risk="1041"/>
              </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>Gena Kantor, MPH</name_or_title>
      <organization>Boston Scientific</organization>
      <phone>1-800-227-3422</phone>
      <email>gena.kantor@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/NCT01688843
org study id: BSC-CDM00048360
nct id: NCT01688843
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The objective of this study is to gather data to establish the safety, performance and
      effectiveness of the INGEVITY pace/ sense leads.
The objective of this study is to gather data to establish the safety, performance and
      effectiveness of the INGEVITY pace/ sense leads
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety 1 - Percentage of Leads Free From Complication (0 - 3 Months)
time frame: Lead implant through 3 month follow up
description: Lead-related complication-free rate from lead implant through the three month follow-up, based on complications that are related to the INGEVITY Lead. The performance goal based on similar leads was set in collaboration with FDA at 91.4%
measure: Safety 2 - Percentage of Leads Free From Complication (3 - 24 Months)
time frame: 3 months through 12 months post implant
description: Lead-related complication-free rate from three months post-implant through twelve months post implant, based on complications that are related to the INGEVITY Lead. The performance goal based on similar leads was set in collaboration with FDA at 94%.
measure: Safety 3 - Hazard Rate of Lead-Related Complications
time frame: Implant through 12 months (including available data beyond 12 months)
description: Hazard rate of lead-related complications over time. This endpoint will use the Weibull distribution to estimate the hazard over time by evaluating the Weibull shape parameter. A Weibull shape greater than one (>1), equal to one (=1) and less than one (<1) indicates accelerating, constant, and decelerating hazard of lead-related complications over time, respectively. This endpoint requires the Weibull shape estimate to be less than 1.
measure: Effectiveness 1
time frame: Lead implant through 3 month follow up
description: The bipolar pacing threshold at 0.5 ms at three months post-implant < 1.5 V
measure: Effectiveness 2(Right Atrium)
time frame: Lead implant through 3 month follow up
description: P-wave sensed amplitude at three months post-implant > 1.5 mV
measure: Effectiveness 2(Right Ventricle)
time frame: Lead implant through 3 month follow up
description: R-wave sensed amplitude at three months post-implant > 5 mV
measure: Effectiveness 3
time frame: Lead implant through 3 month follow up
description: Clinically acceptable pacing impedance between 300 Ω and 1300 Ω
measure: Ancillary Safety
time frame: From 3 to 60 months post-implant
description: Lead-related complication-free rate
arm group label: INGEVITY lead
arm group type: Experimental
description: INGEVITY lead implant
intervention type: Device
intervention name: INGEVITY lead
arm group label: INGEVITY lead
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Charles Love, MD
role: Principal Investigator
affiliation: Johns Hopkins University
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country: Australia
country: Austria
country: Belgium
country: Canada
country: Denmark
country: France
country: Germany
country: Hong Kong
country: Italy
country: Malaysia
country: Portugal
country: Spain
country: Sweden
country: Thailand
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Bradycardia
mesh term: Sick Sinus Syndrome
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