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/NCT06023784</url>
    </required_header>
    <id_info>
      <org_study_id>the July study</org_study_id>
      <nct_id>NCT06023784</nct_id>
    </id_info>
    <brief_title>The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block</brief_title>
    <official_title>The Impact of Left Bundle Branch Area Pacing Versus Right Ventricular Pacing on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block: a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking Union Medical College Hospital</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 single-center, randomized controlled study. The aim of this study is to compare the&#xD;
        impact of left bundle branch area pacing versus traditional right ventricular pacing on the&#xD;
        incidence of atrial fibrillation in patients with atrioventricular block.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2030</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2028</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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>the incidence of new-onset atrial fibrillation</measure>
      <time_frame>within two years after device implantation</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>all-cause mortality</measure>
      <time_frame>within two years after device implantation</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>hospitalization for heart failure</measure>
      <time_frame>within two years after device implantation</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>an device upgrade for heart failure</measure>
      <time_frame>within two years after device implantation</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>alteration of quality of life score</measure>
      <time_frame>within two years after device implantation</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Improvement of left ventricular, right ventricular and left atrial function measured by echocardiography</measure>
      <time_frame>within two years after device implantation</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pacemaker-associated cardiomyopathy</measure>
      <time_frame>within two years after device implantation</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">530</enrollment>
    <condition>Left Bundle Branch Area Pacing</condition>
    <condition>Right Ventricular Pacing</condition>
    <condition>Atrioventricular Block</condition>
    <condition>Atrial Fibrillation</condition>
    <arm_group>
      <arm_group_label>left bundle branch area pacing</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>right ventricular pacing</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>left bundle branch area pacing</intervention_name>
      <description>Left bundle branch area pacing(LBBAP) is a novel physiological pacing form for ventricular pacing. In patients received LBBAP, the pacing lead will be placed at left bundle branch area to achieve narrow paced QRS duration.</description>
      <arm_group_label>left bundle branch area pacing</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>right ventricular pacing</intervention_name>
      <description>Right ventricular pacing is the traditional pacing modality for ventricular pacing. The pacing lead was placed in the apex or septum of right ventricle.</description>
      <arm_group_label>right ventricular pacing</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients aged 18-85;&#xD;
  &#xD;
            -  AV block patients with ventricular pacing indications and the expected rate of&#xD;
               ventricular pacing(VP)&gt; 40%, including (a) third-degree AV block; (b) second degree AV&#xD;
               block (type II); (c) intermittent advanced AV block with expected VP&gt;40%; (d)&#xD;
               symptomatic first degree AV block and PR interval on ECG &gt; 300ms;&#xD;
  &#xD;
            -  Signed informed consent;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Baseline echocardiographic assessment of patients with impaired LV function&#xD;
               (LVEF&lt;50%);&#xD;
  &#xD;
            -  Patients with the history of atrial fibrillation;&#xD;
  &#xD;
            -  Having difficulties in follow-up: Those who cannot accept 2-year follow-up on time due&#xD;
               to physical condition or other reasons;&#xD;
  &#xD;
            -  Pacemaker replacement without new implanted ventricular electrodes;&#xD;
  &#xD;
            -  Surgery is required within 1 year due to severe structural heart disease;&#xD;
  &#xD;
            -  Patients with tricuspid mechanical valve replacement, or congenital heart disease&#xD;
               (including transposition of the great arteries, or permanent left superior vena cava,&#xD;
               etc);&#xD;
  &#xD;
            -  AV block resulting from: (a) Hypertrophic cardiomyopathy(HCM), (b) ventricular septal&#xD;
               defect repair, and those who are unlikely to achieve successful LBBAP procedure.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Taibo Chen, PhD.</last_name>
      <role>Study Chair</role>
      <affiliation>Peking Union Medical College Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Deyan Yang, PhD.</last_name>
      <phone>+86 (010)69155068</phone>
      <email>swallow_sums@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Chinese Academy of Medical Sciences &amp; Peking Union Medical College, Peking Union Medical College Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100730</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Taibo Chen, PhD.</last_name>
        <phone>+86 (010)69155068</phone>
      </contact>
      <contact_backup>
        <last_name>Deyan Yang, PhD.</last_name>
        <phone>+86 (010)69155068</phone>
        <email>swallow_sums@163.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>September 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 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>Atrial Fibrillation</mesh_term>
      <mesh_term>Atrioventricular Block</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/NCT06023784
  org study id: the July study
  nct id: NCT06023784
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a single-center, randomized controlled study. The aim of this study is to compare the
        impact of left bundle branch area pacing versus traditional right ventricular pacing on the
        incidence of atrial fibrillation in patients with atrioventricular block.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: the incidence of new-onset atrial fibrillation
  time frame: within two years after device implantation
  measure: all-cause mortality
  time frame: within two years after device implantation
  measure: hospitalization for heart failure
  time frame: within two years after device implantation
  measure: an device upgrade for heart failure
  time frame: within two years after device implantation
  measure: alteration of quality of life score
  time frame: within two years after device implantation
  measure: Improvement of left ventricular, right ventricular and left atrial function measured by echocardiography
  time frame: within two years after device implantation
  measure: pacemaker-associated cardiomyopathy
  time frame: within two years after device implantation
  arm group label: left bundle branch area pacing
  arm group type: Experimental
  arm group label: right ventricular pacing
  arm group type: Active Comparator
  intervention type: Procedure
  intervention name: left bundle branch area pacing
  description: Left bundle branch area pacing(LBBAP) is a novel physiological pacing form for ventricular pacing. In patients received LBBAP, the pacing lead will be placed at left bundle branch area to achieve narrow paced QRS duration.
  arm group label: left bundle branch area pacing
  intervention type: Procedure
  intervention name: right ventricular pacing
  description: Right ventricular pacing is the traditional pacing modality for ventricular pacing. The pacing lead was placed in the apex or septum of right ventricle.
  arm group label: right ventricular pacing
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Taibo Chen, PhD.
  role: Study Chair
  affiliation: Peking Union Medical College Hospital
  last name: Deyan Yang, PhD.
  phone: +86 (010)69155068
  email: swallow_sums@163.com
  facility: 
  contact: 
  contact backup: 
  country: China
  responsible party type: Sponsor
  mesh term: Atrial Fibrillation
  mesh term: Atrioventricular Block
  sharing ipd: No