<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/NCT04505384</url>
  </required_header>
  <id_info>
    <org_study_id>ZS-LBBPvsBVP</org_study_id>
    <nct_id>NCT04505384</nct_id>
  </id_info>
  <brief_title>Acute Effects of LBBP Versus BVP for CRT</brief_title>
  <official_title>Acute Effects of Left Bundle Branch Pacing Versus Biventricular Pacing for Cardiac Resynchronization Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study was designed to compare the acute effects of left bundle branch pacing (LBBP) with&#xD;
      biventricular pacing (BVP) in patients with left ventricular ejection fraction (LVEF) &lt;=35%&#xD;
      with left bundle branch block (LBBB).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The metrics include electrocardiographic, echocardiographic and hemodynamic parameters to&#xD;
      evaluate and compare LBBP with BVP for resynchronization therapy in patients with heart&#xD;
      failure and LBBB.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">September 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hemodynamic parameter LV dP/dt(max)</measure>
    <time_frame>1 hour</time_frame>
    <description>LV dP/dt(max) will be obtained during implant procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Electrical synchrony parameters including QRS duration and QRS area</measure>
    <time_frame>0.5 hour</time_frame>
    <description>Acquired from EP system during procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mechanical parameters including Ts-SD and IVMD</measure>
    <time_frame>0.5 hour</time_frame>
    <description>Acquired by an echocardiologist during procedure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Heart Failure</condition>
  <condition>Cardiac Pacing, Artificial</condition>
  <condition>Cardiac Resynchronization Therapy</condition>
  <arm_group>
    <arm_group_label>Left bundle branch pacing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Left bundle branch pacing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biventricular pacing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Biventricular pacing</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>left bundle branch pacing</intervention_name>
    <description>left bundle branch pacing</description>
    <arm_group_label>Left bundle branch pacing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>biventricular pacing</intervention_name>
    <description>biventricular pacing</description>
    <arm_group_label>Biventricular pacing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  NYHA class II-IV;&#xD;
&#xD;
          -  LVEF &lt;=35%;&#xD;
&#xD;
          -  LBBB with QRS duration &gt;=130ms.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  moderate-to-severe aortic stenosis;&#xD;
&#xD;
          -  frequent premature ventricular complexes;&#xD;
&#xD;
          -  signiﬁcant peripheral vascular disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yangang Su, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Shanghai Zhongshan Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>180 Fenglin Road</name>
      <address>
        <city>Shanghai</city>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>January 19, 2022</last_update_submitted>
  <last_update_submitted_qc>January 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2022</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>
  </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/NCT04505384
org study id: ZS-LBBPvsBVP
nct id: NCT04505384
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study was designed to compare the acute effects of left bundle branch pacing (LBBP) with
      biventricular pacing (BVP) in patients with left ventricular ejection fraction (LVEF) <=35%
      with left bundle branch block (LBBB).
The metrics include electrocardiographic, echocardiographic and hemodynamic parameters to
      evaluate and compare LBBP with BVP for resynchronization therapy in patients with heart
      failure and LBBB.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Hemodynamic parameter LV dP/dt(max)
time frame: 1 hour
description: LV dP/dt(max) will be obtained during implant procedure.
measure: Electrical synchrony parameters including QRS duration and QRS area
time frame: 0.5 hour
description: Acquired from EP system during procedure
measure: Mechanical parameters including Ts-SD and IVMD
time frame: 0.5 hour
description: Acquired by an echocardiologist during procedure
arm group label: Left bundle branch pacing
arm group type: Experimental
description: Left bundle branch pacing
arm group label: Biventricular pacing
arm group type: Active Comparator
description: Biventricular pacing
intervention type: Procedure
intervention name: left bundle branch pacing
description: left bundle branch pacing
arm group label: Left bundle branch pacing
intervention type: Procedure
intervention name: biventricular pacing
description: biventricular pacing
arm group label: Biventricular pacing
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yangang Su, MD
role: Study Chair
affiliation: Shanghai Zhongshan Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No