xml: <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/NCT06014866</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00113475</org_study_id>
      <nct_id>NCT06014866</nct_id>
    </id_info>
    <brief_title>Conduction System Pacing With INGEVITY+</brief_title>
    <acronym>INSIGHT-LBBA</acronym>
    <official_title>ConductIoN System pacInG witH IngeviTy+ for the Left Bundle Branch Area</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Duke University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Boston Scientific Corporation</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Duke University</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The study is intended to evaluate the safety and effectiveness of the Boston Scientific&#xD;
        INGEVITY+ cardiac pacing lead when implanted in the left bundle branch area (LBBA).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        INSIGHT is a prospectively defined analysis of INGEVITY+ leads that have been previously&#xD;
        implanted in the LBBA for the purpose of anti-bradycardia pacing. The results will provide&#xD;
        complication free rate (safety) and lead measurements (performance).&#xD;
  &#xD;
        Data will be gathered by means of a retrospective, multi-center, US only observational chart&#xD;
        review to obtain data on INGEVITY+ leads implanted in the LBBA. Additional data will be&#xD;
        gathered from the pulse generator and from the LATITUDE remote monitoring system for pacing&#xD;
        thresholds and R-wave amplitude. Consecutive implants will be collected from each site for&#xD;
        evaluating the endpoints.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">February 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Lead-Related Complication Free Rate</measure>
      <time_frame>Implant through 90 days</time_frame>
      <description>Adverse events that require correction with an invasive intervention or resulted in significant loss of device functionality.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pacing Threshold</measure>
      <time_frame>Implant through 90 days</time_frame>
      <description>Percent of INGEVITY+ leads with pacing capture threshold measurement of less than or equal to 2V.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sensed R-wave amplitude</measure>
      <time_frame>Implant through 90 days</time_frame>
      <description>Percent of INGEVITY+ leads with an R-wave amplitude greater than 5mV.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">1500</enrollment>
    <condition>Bradycardia</condition>
    <arm_group>
      <arm_group_label>LBBA INGEVITY+ Pacing</arm_group_label>
      <description>Patients indicated for anti-bradycardia pacing that have been implanted with an INGEVITY+ lead in the LBBA.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Cardiac pacing</intervention_name>
      <description>Patient's previously implanted with the INGEVITY+ lead located in the LBBA</description>
      <arm_group_label>LBBA INGEVITY+ Pacing</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients implanted with an INGEVITY+ lead implanted in the LBBA to provide rate support for&#xD;
          bradycardia.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria for Primary Analysis:&#xD;
  &#xD;
            -  De novo anti-bradycardia pacing pacemaker implant.&#xD;
  &#xD;
            -  INGEVITY+ lead implant attempt in the LBBA as documented in the medical record at&#xD;
               least 90 days ago.&#xD;
  &#xD;
            -  LBBAP implant attempt employed a Boston Scientific SSPC series sheath&#xD;
  &#xD;
          Exclusion Criteria for Primary Analysis:&#xD;
  &#xD;
          -ICD and CRT-D devices&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Day</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Daniel Friedman, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Duke University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Duke University</name>
        <address>
          <city>Durham</city>
          <state>North Carolina</state>
          <zip>27708</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Conduction system pacing</keyword>
    <keyword>Cardiac physiologic pacing</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bradycardia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06014866
  org study id: Pro00113475
  nct id: NCT06014866
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The study is intended to evaluate the safety and effectiveness of the Boston Scientific
        INGEVITY+ cardiac pacing lead when implanted in the left bundle branch area (LBBA).
  INSIGHT is a prospectively defined analysis of INGEVITY+ leads that have been previously
        implanted in the LBBA for the purpose of anti-bradycardia pacing. The results will provide
        complication free rate (safety) and lead measurements (performance).
  
        Data will be gathered by means of a retrospective, multi-center, US only observational chart
        review to obtain data on INGEVITY+ leads implanted in the LBBA. Additional data will be
        gathered from the pulse generator and from the LATITUDE remote monitoring system for pacing
        thresholds and R-wave amplitude. Consecutive implants will be collected from each site for
        evaluating the endpoints.
  observational model: Cohort
  time perspective: Retrospective
  measure: Lead-Related Complication Free Rate
  time frame: Implant through 90 days
  description: Adverse events that require correction with an invasive intervention or resulted in significant loss of device functionality.
  measure: Pacing Threshold
  time frame: Implant through 90 days
  description: Percent of INGEVITY+ leads with pacing capture threshold measurement of less than or equal to 2V.
  measure: Sensed R-wave amplitude
  time frame: Implant through 90 days
  description: Percent of INGEVITY+ leads with an R-wave amplitude greater than 5mV.
  arm group label: LBBA INGEVITY+ Pacing
  description: Patients indicated for anti-bradycardia pacing that have been implanted with an INGEVITY+ lead in the LBBA.
  intervention type: Device
  intervention name: Cardiac pacing
  description: Patient's previously implanted with the INGEVITY+ lead located in the LBBA
  arm group label: LBBA INGEVITY+ Pacing
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 1 Day
  maximum age: N/A
  healthy volunteers: No
  last name: Daniel Friedman, MD
  role: Principal Investigator
  affiliation: Duke University
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Bradycardia
  sharing ipd: No