<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/NCT03008291</url>
  </required_header>
  <id_info>
    <org_study_id>16-005100</org_study_id>
    <nct_id>NCT03008291</nct_id>
  </id_info>
  <brief_title>His Bundle Pacing in Bradycardia and Heart Failure</brief_title>
  <official_title>His Bundle Pacing in Bradycardia and Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yong-Mei Cha</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Participants in this study will either have heart failure (HF) and are scheduled to undergo&#xD;
      pace maker (PM) implantation, cardiac resynchronization therapy pacemaker (CRT-P), cardiac&#xD;
      resynchronization therapy defibrillator (CRT-D) implantation, His bundle pacing (HIBP) or&#xD;
      left bundle area pacing (LBAP) (including HIBP/LBAP for patients with HF, for patients who&#xD;
      have failed CRT implant or patients who are CRT non-responders), or have atrioventricular&#xD;
      (AV) block or bradycardia and are scheduled to undergo dual chamber pacemaker implantation.&#xD;
      In this study additional heart rhythm measurements will be collected during the implant&#xD;
      procedure to better understand how His bundle and/or parahisian pacing (HISP) effects&#xD;
      electrical conduction in the hearts of patients with HF or AV block.&#xD;
&#xD;
      The hypothesis is that His bundle or parahisian pacing (HISP) and left bundle area pacing&#xD;
      (LBAP) may normalize atrioventricular (AV) conduction with a narrow combination of the Q&#xD;
      wave, R wave and S wave (QRS complex) in functional bundle branch block or conduction delay&#xD;
      in patients with heart failure (HF).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">December 2023</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>QRS duration as measured by 12-lead ECG</measure>
    <time_frame>Baseline to 6 months</time_frame>
    <description>The normal duration (interval) of the QRS complex is 0.08 and 0.10 seconds (80 and 100 ms). When the duration is between 0.10 and 0.12 seconds it is intermediate or slightly prolonged. A QRS duration of greater than 0.12 seconds is considered abnormal.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>QRS morphology as measured by 12-lead ECG</measure>
    <time_frame>Baseline to 6 months</time_frame>
    <description>Normal QRS width is 70-100 ms (a duration of 110 ms is sometimes observed in healthy subjects). The QRS width is useful in determining the origin of each QRS complex (e.g. sinus, atrial, junctional or ventricular).</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Bradycardia</condition>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Heart Failure Group</arm_group_label>
    <description>Patients who have any QRS duration and left ventricular ejection fraction (LVEF) ≤ 50% will be enrolled in this arm. The primary care physician will have recommended either PM, CRT-D Implantation, CRT-P Implantation, HIBP or LBAP (including HIBP/LBAP for patients with HF, for patients who have failed CRT implant or patients who are CRT non-responders) . (This is Standard of Care for this patient population; the procedures will occur even if the patient does not participate in the study.)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Atrioventricular Block/Bradycardia Group</arm_group_label>
    <description>Patients who have developed second or third degree atrioventricular block (AV block) or bradycardia will be enrolled in this arm. The primary care physician will have recommended dual chamber pacemaker implantation. (This is Standard of Care for this patient population; the procedures will occur even if the patient does not participate in the study.)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CRT-D Implantation</intervention_name>
    <description>Cardiac resynchronization therapy defibrillator</description>
    <arm_group_label>Heart Failure Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CRT-P Implantation</intervention_name>
    <description>Cardiac resynchronization therapy pacemaker</description>
    <arm_group_label>Heart Failure Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Dual Chamber Pacemaker Implantation</intervention_name>
    <arm_group_label>Atrioventricular Block/Bradycardia Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be recruited from the heart clinic at Mayo Clinic in Rochester, Minnesota.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        HF Group&#xD;
&#xD;
          -  Clinically recommended to undergo PM, CRT-P, or CRT-D implantation or HIBP/LBAP&#xD;
             (including HIBP/LBAP for patients with HF, for patients who have failed CRT implant or&#xD;
             patients who are CRT non-responders)&#xD;
&#xD;
          -  Any QRS duration&#xD;
&#xD;
          -  LVEF ≤ 50%&#xD;
&#xD;
        AV Block/Bradycardia Group&#xD;
&#xD;
          -  Recommended to undergo dual chamber pacemaker implantation&#xD;
&#xD;
          -  Second or third degree AV block or Sinus Bradycardia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Pregnant&#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>Yong-Mei Cha, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yong-Mei Cha, M.D.</last_name>
    <phone>(507) 255-2440</phone>
    <email>ycha@mayo.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Brian W Liddell, B.A.</last_name>
    <phone>(507) 255-8717</phone>
    <email>Liddell.Brian@Mayo.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>November 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>September 28, 2022</last_update_submitted>
  <last_update_submitted_qc>September 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Yong-Mei Cha</investigator_full_name>
    <investigator_title>M.D., Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <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>


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/NCT03008291
org study id: 16-005100
nct id: NCT03008291
lead sponsor: 
has dmc: No
Participants in this study will either have heart failure (HF) and are scheduled to undergo
      pace maker (PM) implantation, cardiac resynchronization therapy pacemaker (CRT-P), cardiac
      resynchronization therapy defibrillator (CRT-D) implantation, His bundle pacing (HIBP) or
      left bundle area pacing (LBAP) (including HIBP/LBAP for patients with HF, for patients who
      have failed CRT implant or patients who are CRT non-responders), or have atrioventricular
      (AV) block or bradycardia and are scheduled to undergo dual chamber pacemaker implantation.
      In this study additional heart rhythm measurements will be collected during the implant
      procedure to better understand how His bundle and/or parahisian pacing (HISP) effects
      electrical conduction in the hearts of patients with HF or AV block.

      The hypothesis is that His bundle or parahisian pacing (HISP) and left bundle area pacing
      (LBAP) may normalize atrioventricular (AV) conduction with a narrow combination of the Q
      wave, R wave and S wave (QRS complex) in functional bundle branch block or conduction delay
      in patients with heart failure (HF).
observational model: Cohort
time perspective: Prospective
measure: QRS duration as measured by 12-lead ECG
time frame: Baseline to 6 months
description: The normal duration (interval) of the QRS complex is 0.08 and 0.10 seconds (80 and 100 ms). When the duration is between 0.10 and 0.12 seconds it is intermediate or slightly prolonged. A QRS duration of greater than 0.12 seconds is considered abnormal.
measure: QRS morphology as measured by 12-lead ECG
time frame: Baseline to 6 months
description: Normal QRS width is 70-100 ms (a duration of 110 ms is sometimes observed in healthy subjects). The QRS width is useful in determining the origin of each QRS complex (e.g. sinus, atrial, junctional or ventricular).
arm group label: Heart Failure Group
description: Patients who have any QRS duration and left ventricular ejection fraction (LVEF) ≤ 50% will be enrolled in this arm. The primary care physician will have recommended either PM, CRT-D Implantation, CRT-P Implantation, HIBP or LBAP (including HIBP/LBAP for patients with HF, for patients who have failed CRT implant or patients who are CRT non-responders) . (This is Standard of Care for this patient population; the procedures will occur even if the patient does not participate in the study.)
arm group label: Atrioventricular Block/Bradycardia Group
description: Patients who have developed second or third degree atrioventricular block (AV block) or bradycardia will be enrolled in this arm. The primary care physician will have recommended dual chamber pacemaker implantation. (This is Standard of Care for this patient population; the procedures will occur even if the patient does not participate in the study.)
intervention type: Procedure
intervention name: CRT-D Implantation
description: Cardiac resynchronization therapy defibrillator
arm group label: Heart Failure Group
intervention type: Procedure
intervention name: CRT-P Implantation
description: Cardiac resynchronization therapy pacemaker
arm group label: Heart Failure Group
intervention type: Procedure
intervention name: Dual Chamber Pacemaker Implantation
arm group label: Atrioventricular Block/Bradycardia Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yong-Mei Cha, M.D.
role: Principal Investigator
affiliation: Mayo Clinic
last name: Yong-Mei Cha, M.D.
phone: (507) 255-2440
email: ycha@mayo.edu
last name: Brian W Liddell, B.A.
phone: (507) 255-8717
email: Liddell.Brian@Mayo.edu
facility: 
status: Recruiting
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Sponsor-Investigator
investigator affiliation: Mayo Clinic
investigator full name: Yong-Mei Cha
investigator title: M.D., Professor of Medicine
mesh term: Heart Failure
mesh term: Bradycardia
sharing ipd: No