<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/NCT03803995</url>
  </required_header>
  <id_info>
    <org_study_id>CRD 969</org_study_id>
    <nct_id>NCT03803995</nct_id>
  </id_info>
  <brief_title>Mapping and Pacing of the His Bundle for Heart Failure Patients With Left Bundle Branch Block</brief_title>
  <acronym>MAP HIS HF</acronym>
  <official_title>Mapping and Pacing of the His Bundle for Heart Failure Patients With Left Bundle Branch Block</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Devices</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, single-arm, non-randomized, non-blinded study designed to characterize&#xD;
      the locations of His Bundle (HB) pacing that results in correction of electrical dyssynchrony&#xD;
      and to characterize morphology and activation time of local intracardiac electrogram (IEGM)&#xD;
      with an electro-anatomical mapping system during a device implant procedure and secondarily&#xD;
      to assess the efficacy of HB pacing or HB plus LV pacing (when indicated) in correction of&#xD;
      electrical dyssynchrony in heart failure patients with left bundle branch block.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 20, 2019</start_date>
  <completion_date type="Anticipated">June 20, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 20, 2024</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>Successful HB pacing sites</measure>
    <time_frame>At device implant procedure</time_frame>
    <description>Collect 3D Locations and electrogram characteristics (morphology and activation time) at the sites where His Bundle (HB) pacing is associated with left bundle recruitment and corrects electrical dyssynchrony at HB pacing implant procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Success rate of HB pacing</measure>
    <time_frame>At device implant procedure</time_frame>
    <description>Measure success rate of HB pacing or HB plus Left ventricular (LV) pacing in the correction of electrical dyssynchrony at implant procedure;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventricular activation during HB pacing</measure>
    <time_frame>At device implant procedure</time_frame>
    <description>Collect ventricular activation times during HB pacing or HB plus LV pacing as compared with intrinsic rhythm and other pacing configurations at implant procedure;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Echocardiographic measurements of LV ejection fraction</measure>
    <time_frame>At three-month follow-up</time_frame>
    <description>Collect echo measurements of LV ejection fraction at three-month follow-up visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Echocardiographic measurements of LV end-systolic volume</measure>
    <time_frame>At three-month follow-up</time_frame>
    <description>Collect echo measurements of LV end-systolic volume at three-month follow-up visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Capture threshold of HB pacing</measure>
    <time_frame>Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit</time_frame>
    <description>Measure capture threshold in volts of HB pacing at implant and at follow-up visits post implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lead impedance of HB pacing lead</measure>
    <time_frame>Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit</time_frame>
    <description>Measure lead impedance in ohms of HB pacing lead at implant and at follow-up visits post implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensing amplitude of HB pacing lead</measure>
    <time_frame>Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit</time_frame>
    <description>Measure sensing amplitude in millivolts of HB pacing lead at implant and at follow-up visits post implant</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Heart Failure</condition>
  <condition>Left Bundle-Branch Block</condition>
  <arm_group>
    <arm_group_label>Mapping and Pacing the His Bundle</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All patients will be in this arm. Mapping and Pacing the His Bundle will be performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mapping and Pacing the His Bundle</intervention_name>
    <description>During the device implant procedure, 3D electro-anatomical mapping of the His Bundle region will be performed using EnSite™ Precision™ mapping system and Advisor™ HD Grid mapping catheter. This procedure might be part of the standard-of-care at the participating centers.</description>
    <arm_group_label>Mapping and Pacing the His Bundle</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Placing a guidewire in Coronary sinus for measurement of Q-LV during His Bundle pacing or, if needed, for LV pacing</intervention_name>
    <description>During the device implant procedure, a VisionWire coronary guidewire will also be placed into a branch of coronary sinus (CS), targeting a lateral branch. This guidewire could be used for collecting local left ventricle (LV) activation time (Q-LV) or pacing the LV. This guidewire could also be used to deliver a LV lead at physician's discretion. This procedure might be part of the standard-of-care at the participating centers.</description>
    <arm_group_label>Mapping and Pacing the His Bundle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients are undergoing implant of an Abbott pacemaker or CRT device under standard&#xD;
             indications&#xD;
&#xD;
          2. An ECG with a wide QRS complex (&gt;130 ms)&#xD;
&#xD;
          3. ECG morphology of typical complete LBBB,&#xD;
&#xD;
          4. Patients have heart failure with NYHA Class II-IV symptoms,&#xD;
&#xD;
          5. LV EF &lt;50%&#xD;
&#xD;
          6. At least 18 years old and not pregnant.&#xD;
&#xD;
          7. Must provide written informed consent prior to any clinical investigation related&#xD;
             procedure.&#xD;
&#xD;
          8. Willing to comply with study evaluation requirements&#xD;
&#xD;
          9. Female subjects of child-bearing potential are required to have a negative pregnancy&#xD;
             test done within 7 days prior to the implant procedure per site standard test. Female&#xD;
             patients of childbearing potential should be instructed to use safe contraception&#xD;
             (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants,&#xD;
             transdermal patches hormonal vaginal devices, injections with prolonged release.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients have non-specific intraventricular conduction delay or right bundle branch&#xD;
             block&#xD;
&#xD;
          2. Previously implanted cardiac devices with three or more permanent leads&#xD;
&#xD;
          3. History of aortic valve repair or replacement&#xD;
&#xD;
          4. History of tricuspid valve replacement&#xD;
&#xD;
          5. Pregnant or nursing subjects and those who plan pregnancy during the clinical&#xD;
             investigation follow-up period.&#xD;
&#xD;
          6. Recent (&lt; 3 months) myocardial infarction, ablation, electrolyte imbalance, or any&#xD;
             condition within the last 90 days that would contraindicate for pacemaker or CRT&#xD;
             implant in the opinion of the investigator&#xD;
&#xD;
          7. Presence of other anatomic or comorbid conditions, or other medical, social, or&#xD;
             psychological conditions that, in the investigator's opinion, could limit the&#xD;
             subject's ability to participate in the clinical investigation or to comply with&#xD;
             follow-up requirements, or impact the scientific soundness of the clinical&#xD;
             investigation results.&#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_contact>
    <last_name>Wenwen Li, PhD</last_name>
    <phone>4085226207</phone>
    <email>wenwen.li@abbott.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tampa General Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bengt Herweg, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>April 3, 2023</last_update_submitted>
  <last_update_submitted_qc>April 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Bundle-Branch Block</mesh_term>
    <mesh_term>Heart Block</mesh_term>
  </condition_browse>
  <!-- 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/NCT03803995
org study id: CRD 969
nct id: NCT03803995
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a prospective, single-arm, non-randomized, non-blinded study designed to characterize
      the locations of His Bundle (HB) pacing that results in correction of electrical dyssynchrony
      and to characterize morphology and activation time of local intracardiac electrogram (IEGM)
      with an electro-anatomical mapping system during a device implant procedure and secondarily
      to assess the efficacy of HB pacing or HB plus LV pacing (when indicated) in correction of
      electrical dyssynchrony in heart failure patients with left bundle branch block.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Successful HB pacing sites
time frame: At device implant procedure
description: Collect 3D Locations and electrogram characteristics (morphology and activation time) at the sites where His Bundle (HB) pacing is associated with left bundle recruitment and corrects electrical dyssynchrony at HB pacing implant procedure.
measure: Success rate of HB pacing
time frame: At device implant procedure
description: Measure success rate of HB pacing or HB plus Left ventricular (LV) pacing in the correction of electrical dyssynchrony at implant procedure;
measure: Ventricular activation during HB pacing
time frame: At device implant procedure
description: Collect ventricular activation times during HB pacing or HB plus LV pacing as compared with intrinsic rhythm and other pacing configurations at implant procedure;
measure: Echocardiographic measurements of LV ejection fraction
time frame: At three-month follow-up
description: Collect echo measurements of LV ejection fraction at three-month follow-up visit
measure: Echocardiographic measurements of LV end-systolic volume
time frame: At three-month follow-up
description: Collect echo measurements of LV end-systolic volume at three-month follow-up visit
measure: Capture threshold of HB pacing
time frame: Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit
description: Measure capture threshold in volts of HB pacing at implant and at follow-up visits post implant
measure: Lead impedance of HB pacing lead
time frame: Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit
description: Measure lead impedance in ohms of HB pacing lead at implant and at follow-up visits post implant
measure: Sensing amplitude of HB pacing lead
time frame: Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit
description: Measure sensing amplitude in millivolts of HB pacing lead at implant and at follow-up visits post implant
arm group label: Mapping and Pacing the His Bundle
arm group type: Other
description: All patients will be in this arm. Mapping and Pacing the His Bundle will be performed.
intervention type: Procedure
intervention name: Mapping and Pacing the His Bundle
description: During the device implant procedure, 3D electro-anatomical mapping of the His Bundle region will be performed using EnSite™ Precision™ mapping system and Advisor™ HD Grid mapping catheter. This procedure might be part of the standard-of-care at the participating centers.
arm group label: Mapping and Pacing the His Bundle
intervention type: Procedure
intervention name: Placing a guidewire in Coronary sinus for measurement of Q-LV during His Bundle pacing or, if needed, for LV pacing
description: During the device implant procedure, a VisionWire coronary guidewire will also be placed into a branch of coronary sinus (CS), targeting a lateral branch. This guidewire could be used for collecting local left ventricle (LV) activation time (Q-LV) or pacing the LV. This guidewire could also be used to deliver a LV lead at physician's discretion. This procedure might be part of the standard-of-care at the participating centers.
arm group label: Mapping and Pacing the His Bundle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wenwen Li, PhD
phone: 4085226207
email: wenwen.li@abbott.com
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Bundle-Branch Block
mesh term: Heart Block