<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/NCT03294317</url>
  </required_header>
  <id_info>
    <org_study_id>IMAGE-HBP</org_study_id>
    <nct_id>NCT03294317</nct_id>
  </id_info>
  <brief_title>Imaging Study of Lead Implant for His Bundle Pacing</brief_title>
  <acronym>(IMAGE-HBP)</acronym>
  <official_title>Imagining Study of Lead Implant for His Bundle Pacing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Cardiac Rhythm and Heart Failure</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Cardiac Rhythm and Heart Failure</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 purpose of this research study is to assess the implant success proportion of the&#xD;
      Medtronic SelectSecure MRI SureScan Model 3830 pacing lead at the bundle of His for His&#xD;
      bundle pacing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will evaluate implant lead electrical measurements and changes over time, estimate&#xD;
      the correlation between lead location and selective vs non-selective His bundle pacing, and&#xD;
      estimate the correlation between long-term lead performance and implant characteristics. Data&#xD;
      from the study may be used to standardize the implant workflow to help improve the ease and&#xD;
      predictability of His bundle pacing implants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 29, 2017</start_date>
  <completion_date type="Actual">January 24, 2020</completion_date>
  <primary_completion_date type="Actual">April 24, 2019</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>Implant Success</measure>
    <time_frame>Day of implant</time_frame>
    <description>To determine the proportion implant successes from all subjects who undergo an implant attempt of a lead at the bundle of His for His bundle pacing. Implant success will be defined as the presence of a H wave on the implanted lead EGM and a His-bundle pacing capture threshold equal to or less than 2.5V at 1.0ms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Association Between the Lead Position and Selective vs. Nonselective HBP Occurrence at Implant</measure>
    <time_frame>Day of implant</time_frame>
    <description>Relationship between lead position (anterior septum, mid septum, posterior septum) and His-bundle pacing selectivity (selective vs. non-selective)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in His-bundle Pacing Capture Thresholds Over Time</measure>
    <time_frame>12 months</time_frame>
    <description>The change in the His-bundle pacing capture threshold from implant to 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Impedance Over Time</measure>
    <time_frame>12 months</time_frame>
    <description>To evaluate impedance from implant to 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in R-wave Amplitude Over Time</measure>
    <time_frame>12 months</time_frame>
    <description>To evaluate R-wave amplitude from implant to 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in QRS Duration Over Time</measure>
    <time_frame>12 months</time_frame>
    <description>Intrinsic QRS duration measured prior to implant procedure and compared to measurements during follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association Between Lead Location and Long-term Lead Electrical Performance</measure>
    <time_frame>12 months</time_frame>
    <description>To assess the association between lead location and long-term lead electrical performance defined by the His-bundle pacing capture threshold at 12 months post-implant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation Between His-bundle Pacing Capture Threshold at Implant and Long-term Lead Electrical Performance</measure>
    <time_frame>12 months</time_frame>
    <description>To assess the correlation between His-bundle pacing capture threshold at implant and long-term lead electrical performance defined by the His-bundle pacing capture threshold at 12 months post-implant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation Between Paced QRS Duration at Implant and Long-term Lead Electrical Performance</measure>
    <time_frame>12 months</time_frame>
    <description>To assess the correlation between paced QRS duration at implant and long-term lead electrical performance defined by the His-bundle pacing capture threshold at 12 months post-implant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications Related to the Procedure or the Lead for His Bundle Pacing</measure>
    <time_frame>12 months</time_frame>
    <description>Adverse events that are complications related to the procedure or the lead for His bundle pacing will be summarized</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>Cardiac Pacemaker, Artificial</condition>
  <arm_group>
    <arm_group_label>His Bundle Pacing</arm_group_label>
    <description>Patient will be implanted per indications for single or dual chamber pacemaker. Lead for His bundle pacing will be implanted.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>His bundle pacing</intervention_name>
    <description>Medtronic SelectSecure SureScan MRI model 3830 lead</description>
    <arm_group_label>His Bundle Pacing</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Bradycardia patients, AV Block patients, Sinus Node Dysfunction patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has a Class I or II indication for implantation of an implantable pacemaker&#xD;
&#xD;
          -  Subject (or legally authorized representative) has signed and dated the study-specific&#xD;
             Consent Form&#xD;
&#xD;
          -  Subject is 18 years of age or older, or is of legal age to give informed consent per&#xD;
             local and national law&#xD;
&#xD;
          -  Subject is expected to remain available for follow-up visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is contraindicated for Cardiac CT&#xD;
&#xD;
          -  Subject has an existing or prior pacemaker, ICD or CRT device implant&#xD;
&#xD;
          -  Subject is intended to receive an implant of a LV lead or CRT device&#xD;
&#xD;
          -  Subject life expectancy is less than 1 year&#xD;
&#xD;
          -  Pregnant women or breastfeeding women, or women of child bearing potential and who are&#xD;
             not on a reliable form of birth regulation method or abstinence&#xD;
&#xD;
          -  Subjects with exclusion criteria required by local law (e.g. age or other)&#xD;
&#xD;
          -  Subject with a medical condition that precludes the patient from participation in the&#xD;
             opinion of the investigator&#xD;
&#xD;
          -  Subject is enrolled in a concurrent study that may confound the results of this study.&#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>Pugazhendhi Vijayaraman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Geisinger Wyoming Valley Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Indiana University - Krannert Institute of Cardiology</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geisinger Wyoming Valley Medical Center</name>
      <address>
        <city>Wilkes-Barre</city>
        <state>Pennsylvania</state>
        <zip>18711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University Health System</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <results_first_submitted>April 13, 2021</results_first_submitted>
  <results_first_submitted_qc>May 28, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 1, 2021</results_first_posted>
  <last_update_submitted>May 28, 2021</last_update_submitted>
  <last_update_submitted_qc>May 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>His bundle pacing</keyword>
  <keyword>Pacemaker</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 19, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT03294317/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 26, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT03294317/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 26, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT03294317/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>70 subjects signed consent. Per the protocol , a subject is considered enrolled in the study upon signing and dating the informed consent. Of the 70 who signed informed consent, 69 were considered &quot;enrolled&quot; per the protocol. 1 was &quot;screen failure&quot;, i.e they signed informed consent, but ended up failing inclusion/exclusion</recruitment_details>
      <pre_assignment_details>Of the 70 subjects who signed informed consent, 1 failed inclusion/exclusion criteria and was exited from the study and left us with 69 subjects. 8 of the 69 subjects were &quot;Implant Attempted&quot; i.e they failed HB lead implant and was exited from the study. 61 subjects had the lead placed at the His-bundle and for various reasons, such as lost to follow-up, physician decision, subject withdrew, received CRT 11 of the subjects were exited leaving us with 50 subjects who completed the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>His Bundle Pacing</title>
          <description>Patient will be implanted per indications for single or dual chamber pacemaker. Lead for His bundle pacing will be implanted.&#xD;
His bundle pacing: Medtronic SelectSecure SureScan MRI model 3830 lead</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Implanted With Lead at HIS Bundle</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Subjects With Available CT</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did not meet inclusion/exclusion criteria</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Failed HB lead implant</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Received CRT instead</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Exited after lead revision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline demographics and medical history were summarized for all subjects with an implant attempt in the study.</population>
      <group_list>
        <group group_id="B1">
          <title>His Bundle Pacing</title>
          <description>Patient will be implanted per indications for single or dual chamber pacemaker. Lead for His bundle pacing will be implanted.&#xD;
His bundle pacing: Medtronic SelectSecure SureScan MRI model 3830 lead</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="69"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</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="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74" spread="12"/>
                  </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="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                  </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>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Implant Success</title>
        <description>To determine the proportion implant successes from all subjects who undergo an implant attempt of a lead at the bundle of His for His bundle pacing. Implant success will be defined as the presence of a H wave on the implanted lead EGM and a His-bundle pacing capture threshold equal to or less than 2.5V at 1.0ms.</description>
        <time_frame>Day of implant</time_frame>
        <population>The primary objective is to assess the implant success proportion of the Medtronic Model 3830 pacing lead at the bundle of His for His Bundle Pacing. The observed implant success proportion was calculated as follows:&#xD;
Implant Success Proportion= ( # Subjects with implant success)/( # Subjects with implant attempt) The observed implant success proportion was 75.36% and the 95% confidence interval is 64.04% - 84.01%.</population>
        <group_list>
          <group group_id="O1">
            <title>His Bundle Pacing</title>
            <description>Patient will be implanted per indications for single or dual chamber pacemaker. Lead for His bundle pacing will be implanted.&#xD;
His bundle pacing: Medtronic SelectSecure SureScan MRI model 3830 lead</description>
          </group>
        </group_list>
        <measure>
          <title>Implant Success</title>
          <description>To determine the proportion implant successes from all subjects who undergo an implant attempt of a lead at the bundle of His for His bundle pacing. Implant success will be defined as the presence of a H wave on the implanted lead EGM and a His-bundle pacing capture threshold equal to or less than 2.5V at 1.0ms.</description>
          <population>The primary objective is to assess the implant success proportion of the Medtronic Model 3830 pacing lead at the bundle of His for His Bundle Pacing. The observed implant success proportion was calculated as follows:&#xD;
Implant Success Proportion= ( # Subjects with implant success)/( # Subjects with implant attempt) The observed implant success proportion was 75.36% and the 95% confidence interval is 64.04% - 84.01%.</population>
          <units>% of subjects with successful implant</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.36" lower_limit="64.04" upper_limit="84.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Association Between the Lead Position and Selective vs. Nonselective HBP Occurrence at Implant</title>
        <description>Relationship between lead position (anterior septum, mid septum, posterior septum) and His-bundle pacing selectivity (selective vs. non-selective)</description>
        <time_frame>Day of implant</time_frame>
        <population>The lead position is analyzed using two variables. The first variable is whether the lead tip is on the atrial or ventricular side of the TV annulus. The second variable is whether the lead tip is above or below the CS line, on the atrial side, or the RV line, on the ventricular side of the TV. The relationship between lead position was assessed using a logistic regression where the dependent variable was HB pacing type and the independent variables were the two lead position variables.</population>
        <group_list>
          <group group_id="O1">
            <title>His Bundle Pacing</title>
            <description>Patient will be implanted per indications for single or dual chamber pacemaker. Lead for His bundle pacing will be implanted.&#xD;
His bundle pacing: Medtronic SelectSecure SureScan MRI model 3830 lead</description>
          </group>
        </group_list>
        <measure>
          <title>Association Between the Lead Position and Selective vs. Nonselective HBP Occurrence at Implant</title>
          <description>Relationship between lead position (anterior septum, mid septum, posterior septum) and His-bundle pacing selectivity (selective vs. non-selective)</description>
          <population>The lead position is analyzed using two variables. The first variable is whether the lead tip is on the atrial or ventricular side of the TV annulus. The second variable is whether the lead tip is above or below the CS line, on the atrial side, or the RV line, on the ventricular side of the TV. The relationship between lead position was assessed using a logistic regression where the dependent variable was HB pacing type and the independent variables were the two lead position variables.</population>
          <units>odds ratio</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Atrial/Ventricular side of TV annulus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.27" lower_limit="0.24" upper_limit="6.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Above/Below side of CS/RV line</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.57" lower_limit="0.14" upper_limit="2.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in His-bundle Pacing Capture Thresholds Over Time</title>
        <description>The change in the His-bundle pacing capture threshold from implant to 12 months</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>His Bundle Pacing</title>
            <description>Patient will be implanted per indications for single or dual chamber pacemaker. Lead for His bundle pacing will be implanted.&#xD;
His bundle pacing: Medtronic SelectSecure SureScan MRI model 3830 lead</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in His-bundle Pacing Capture Thresholds Over Time</title>
          <description>The change in the His-bundle pacing capture threshold from implant to 12 months</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="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.82" spread="1.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Impedance Over Time</title>
        <description>To evaluate impedance from implant to 12 months</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>His Bundle Pacing</title>
            <description>Patient will be implanted per indications for single or dual chamber pacemaker. Lead for His bundle pacing will be implanted.&#xD;
His bundle pacing: Medtronic SelectSecure SureScan MRI model 3830 lead</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Impedance Over Time</title>
          <description>To evaluate impedance from implant to 12 months</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="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="429.72" spread="79.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in R-wave Amplitude Over Time</title>
        <description>To evaluate R-wave amplitude from implant to 12 months</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>His Bundle Pacing</title>
            <description>Patient will be implanted per indications for single or dual chamber pacemaker. Lead for His bundle pacing will be implanted.&#xD;
His bundle pacing: Medtronic SelectSecure SureScan MRI model 3830 lead</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in R-wave Amplitude Over Time</title>
          <description>To evaluate R-wave amplitude from implant to 12 months</description>
          <units>millivolts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.10" spread="2.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in QRS Duration Over Time</title>
        <description>Intrinsic QRS duration measured prior to implant procedure and compared to measurements during follow-up</description>
        <time_frame>12 months</time_frame>
        <population>The QRS duration measurements evaluated include both intrinsic, paced QRS duration during pacing threshold testing, and paced QRS duration at final programming. Longitudinal analysis was conducted to estimate differences in QRS duration measurements from implant to subsequent follow-up visits using a mixed effects model.</population>
        <group_list>
          <group group_id="O1">
            <title>His Bundle Pacing</title>
            <description>Patient will be implanted per indications for single or dual chamber pacemaker. Lead for His bundle pacing will be implanted.&#xD;
His bundle pacing: Medtronic SelectSecure SureScan MRI model 3830 lead</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in QRS Duration Over Time</title>
          <description>Intrinsic QRS duration measured prior to implant procedure and compared to measurements during follow-up</description>
          <population>The QRS duration measurements evaluated include both intrinsic, paced QRS duration during pacing threshold testing, and paced QRS duration at final programming. Longitudinal analysis was conducted to estimate differences in QRS duration measurements from implant to subsequent follow-up visits using a mixed effects model.</population>
          <units>milliseconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105.00" spread="32.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Association Between Lead Location and Long-term Lead Electrical Performance</title>
        <description>To assess the association between lead location and long-term lead electrical performance defined by the His-bundle pacing capture threshold at 12 months post-implant.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>His Bundle Pacing</title>
            <description>Patient will be implanted per indications for single or dual chamber pacemaker. Lead for His bundle pacing will be implanted.&#xD;
His bundle pacing: Medtronic SelectSecure SureScan MRI model 3830 lead</description>
          </group>
        </group_list>
        <measure>
          <title>Association Between Lead Location and Long-term Lead Electrical Performance</title>
          <description>To assess the association between lead location and long-term lead electrical performance defined by the His-bundle pacing capture threshold at 12 months post-implant.</description>
          <units>Regression coefficient</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Atrial/Ventricular side of TV annulus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.070681015" lower_limit="-0.587845" upper_limit="0.729207"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Above/Below side of CS/RV line</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.106436807" lower_limit="-0.439328" upper_limit="0.652202"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Correlation Between His-bundle Pacing Capture Threshold at Implant and Long-term Lead Electrical Performance</title>
        <description>To assess the correlation between His-bundle pacing capture threshold at implant and long-term lead electrical performance defined by the His-bundle pacing capture threshold at 12 months post-implant.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>His Bundle Pacing</title>
            <description>Patient will be implanted per indications for single or dual chamber pacemaker. Lead for His bundle pacing will be implanted.&#xD;
His bundle pacing: Medtronic SelectSecure SureScan MRI model 3830 lead</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation Between His-bundle Pacing Capture Threshold at Implant and Long-term Lead Electrical Performance</title>
          <description>To assess the correlation between His-bundle pacing capture threshold at implant and long-term lead electrical performance defined by the His-bundle pacing capture threshold at 12 months post-implant.</description>
          <units>Regression coefficient</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.308729841" lower_limit="0.008103" upper_limit="0.609357"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Correlation Between Paced QRS Duration at Implant and Long-term Lead Electrical Performance</title>
        <description>To assess the correlation between paced QRS duration at implant and long-term lead electrical performance defined by the His-bundle pacing capture threshold at 12 months post-implant.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>His Bundle Pacing</title>
            <description>Patient will be implanted per indications for single or dual chamber pacemaker. Lead for His bundle pacing will be implanted.&#xD;
His bundle pacing: Medtronic SelectSecure SureScan MRI model 3830 lead</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation Between Paced QRS Duration at Implant and Long-term Lead Electrical Performance</title>
          <description>To assess the correlation between paced QRS duration at implant and long-term lead electrical performance defined by the His-bundle pacing capture threshold at 12 months post-implant.</description>
          <units>Regression coefficient</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.001329355" lower_limit="-0.012422" upper_limit="0.009763"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Complications Related to the Procedure or the Lead for His Bundle Pacing</title>
        <description>Adverse events that are complications related to the procedure or the lead for His bundle pacing will be summarized</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>His Bundle Pacing</title>
            <description>Patient will be implanted per indications for single or dual chamber pacemaker. Lead for His bundle pacing will be implanted.&#xD;
His bundle pacing: Medtronic SelectSecure SureScan MRI model 3830 lead</description>
          </group>
        </group_list>
        <measure>
          <title>Complications Related to the Procedure or the Lead for His Bundle Pacing</title>
          <description>Adverse events that are complications related to the procedure or the lead for His bundle pacing will be summarized</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected over a period of 12 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>His Bundle Pacing</title>
          <description>Patient will be implanted per indications for single or dual chamber pacemaker. Lead for His bundle pacing will be implanted.&#xD;
His bundle pacing: Medtronic SelectSecure SureScan MRI model 3830 lead</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Device capturing issue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Device pacing issue</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="69"/>
              </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="3" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Device pacing issue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Bundle branch block right</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="69"/>
              </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>Investigator and Participating Institution shall submit any contemplated publication or presentation of this study to Medtronic for review at least 60 days prior to submission, If notified by Medtronic within such 60- day period that such publication or presentation contains Confidential Information, Investigator and Participating Institution each agree to delete Confidential Information, other than Study results, prior to any publication or presentation.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Nonye Harcourt</name_or_title>
      <organization>Medtronic CRM Clinical</organization>
      <phone>6122421785</phone>
      <email>nonye.o.harcourt@medtronic.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/NCT03294317
org study id: IMAGE-HBP
nct id: NCT03294317
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this research study is to assess the implant success proportion of the
      Medtronic SelectSecure MRI SureScan Model 3830 pacing lead at the bundle of His for His
      bundle pacing.
The study will evaluate implant lead electrical measurements and changes over time, estimate
      the correlation between lead location and selective vs non-selective His bundle pacing, and
      estimate the correlation between long-term lead performance and implant characteristics. Data
      from the study may be used to standardize the implant workflow to help improve the ease and
      predictability of His bundle pacing implants.
observational model: Cohort
time perspective: Prospective
measure: Implant Success
time frame: Day of implant
description: To determine the proportion implant successes from all subjects who undergo an implant attempt of a lead at the bundle of His for His bundle pacing. Implant success will be defined as the presence of a H wave on the implanted lead EGM and a His-bundle pacing capture threshold equal to or less than 2.5V at 1.0ms.
measure: Association Between the Lead Position and Selective vs. Nonselective HBP Occurrence at Implant
time frame: Day of implant
description: Relationship between lead position (anterior septum, mid septum, posterior septum) and His-bundle pacing selectivity (selective vs. non-selective)
measure: Changes in His-bundle Pacing Capture Thresholds Over Time
time frame: 12 months
description: The change in the His-bundle pacing capture threshold from implant to 12 months
measure: Changes in Impedance Over Time
time frame: 12 months
description: To evaluate impedance from implant to 12 months
measure: Changes in R-wave Amplitude Over Time
time frame: 12 months
description: To evaluate R-wave amplitude from implant to 12 months
measure: Changes in QRS Duration Over Time
time frame: 12 months
description: Intrinsic QRS duration measured prior to implant procedure and compared to measurements during follow-up
measure: Association Between Lead Location and Long-term Lead Electrical Performance
time frame: 12 months
description: To assess the association between lead location and long-term lead electrical performance defined by the His-bundle pacing capture threshold at 12 months post-implant.
measure: Correlation Between His-bundle Pacing Capture Threshold at Implant and Long-term Lead Electrical Performance
time frame: 12 months
description: To assess the correlation between His-bundle pacing capture threshold at implant and long-term lead electrical performance defined by the His-bundle pacing capture threshold at 12 months post-implant.
measure: Correlation Between Paced QRS Duration at Implant and Long-term Lead Electrical Performance
time frame: 12 months
description: To assess the correlation between paced QRS duration at implant and long-term lead electrical performance defined by the His-bundle pacing capture threshold at 12 months post-implant.
measure: Complications Related to the Procedure or the Lead for His Bundle Pacing
time frame: 12 months
description: Adverse events that are complications related to the procedure or the lead for His bundle pacing will be summarized
arm group label: His Bundle Pacing
description: Patient will be implanted per indications for single or dual chamber pacemaker. Lead for His bundle pacing will be implanted.
intervention type: Device
intervention name: His bundle pacing
description: Medtronic SelectSecure SureScan MRI model 3830 lead
arm group label: His Bundle Pacing
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pugazhendhi Vijayaraman, MD
role: Principal Investigator
affiliation: Geisinger Wyoming Valley Medical Center
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 