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/NCT05985408</url>
    </required_header>
    <id_info>
      <org_study_id>2023-0801</org_study_id>
      <nct_id>NCT05985408</nct_id>
    </id_info>
    <brief_title>LVSP Based CRT vs. RVAP Based CRT</brief_title>
    <official_title>Left Ventricular Septal Pacing Based Rescue CRT Versus Right Ventricular Apical Pacing Based CRT for Chronic Heart Failure: a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fu Wai Hospital, Beijing, China</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fu Wai Hospital, Beijing, China</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        To find out whether left ventricular septal pacing (LVSP)-based cardiac resynchronization&#xD;
        therapy (CRT) is superior to right ventricular apical pacing (RVAP)-based CRT in patients&#xD;
        with failed left bundle branch pacing at the beginning of chronic heart failure.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2025</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>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>left ventricular ejection fraction (LVEF)</measure>
      <time_frame>6 months</time_frame>
      <description>LVEF evaluated by echocardiography，Bi-plane Simpson's method</description>
    </primary_outcome>
    <primary_outcome>
      <measure>left ventricular ejection fraction (LVEF)</measure>
      <time_frame>12 months</time_frame>
      <description>LVEF evaluated by echocardiography，Bi-plane Simpson's method</description>
    </primary_outcome>
    <primary_outcome>
      <measure>left ventricular end-systolic volume (LVESV)</measure>
      <time_frame>6 months</time_frame>
      <description>LVESV evaluated by echocardiography</description>
    </primary_outcome>
    <primary_outcome>
      <measure>left ventricular end-systolic volume (LVESV)</measure>
      <time_frame>12 months</time_frame>
      <description>LVESV evaluated by echocardiography</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>paced QRSd duration.</measure>
      <time_frame>6 months</time_frame>
      <description>QRS duration measurement after the procedure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>paced QRSd duration.</measure>
      <time_frame>12 months</time_frame>
      <description>QRS duration measurement after the procedure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>NT-proBNP</measure>
      <time_frame>6 months</time_frame>
      <description>Serum NT-proBNP level</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>NT-proBNP</measure>
      <time_frame>12 months</time_frame>
      <description>Serum NT-proBNP level</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>6-minute hall walk distance</measure>
      <time_frame>6 months</time_frame>
      <description>6-minute hall walk distance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>6-minute hall walk distance</measure>
      <time_frame>12 months</time_frame>
      <description>6-minute hall walk distance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heart failure rehospitalization</measure>
      <time_frame>6 months</time_frame>
      <description>Rehospitalization due to the exacerbation of heart failure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heart failure rehospitalization</measure>
      <time_frame>12 months</time_frame>
      <description>Rehospitalization due to the exacerbation of heart failure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rehospitalization for cardiovascular adverse events</measure>
      <time_frame>12 months</time_frame>
      <description>Rehospitalization for cardiovascular adverse events</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Malignant ventricular arrhythmias</measure>
      <time_frame>6 months</time_frame>
      <description>ICD therapy for ventricular tachycardia or ventricular fibrillation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Malignant ventricular arrhythmias</measure>
      <time_frame>12 months</time_frame>
      <description>ICD therapy for ventricular tachycardia or ventricular fibrillation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All cause death</measure>
      <time_frame>6 months</time_frame>
      <description>All cause death events</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All cause death</measure>
      <time_frame>12 months</time_frame>
      <description>All cause death events</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Heart Failure</condition>
    <condition>Cardiac Resynchronization Therapy</condition>
    <condition>Left Ventricular Septal Pacing</condition>
    <condition>Right Ventricular Septal Pacing</condition>
    <arm_group>
      <arm_group_label>LVSP-CRT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients received LVSP based CRT implantation; LVSP, left ventricular septal pacing; CRT, cardiac resynchronization therapy.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>RVAP-CRT</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients received RVAP based CRT implantation; RVAP, right ventricular apical pacing; CRT, cardiac resynchronization therapy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>left ventricular septal pacing</intervention_name>
      <description>For left bundle branch pacing (LBBP) failure cases, use left ventricular septal pacing instead of LBBP; others were same as traditional CRT.</description>
      <arm_group_label>LVSP-CRT</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>right ventricular apical pacing</intervention_name>
      <description>For left bundle branch pacing (LBBP) failure cases, use right ventricular apical pacing instead of LBBP; others were same as traditional CRT.</description>
      <arm_group_label>RVAP-CRT</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          1. Chronic heart failure, LVEF ≤35% after at least 3 months of guideline-optimized drug&#xD;
          therapy, NYHA class II-IV with complete left bundle branch block (QRSd≥130 ms), OR&#xD;
          Atrioventricular block with LVEF ≤ 50% with the indication of cardiac pacing; 3. Age&#xD;
          between 18 and 90 years old; 4. The expected survival period is greater than 12 months; 5.&#xD;
          Signed the informed consent form for the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Previous mechanical tricuspid valve replacement.&#xD;
  &#xD;
            2. Previous pacemaker or other devices implanted and for device replacement or upgrading&#xD;
               for this time.&#xD;
  &#xD;
            3. Patients have a history of unstable angina, acute myocardial infarction, CABG, and PCI&#xD;
               surgery within three months.&#xD;
  &#xD;
            4. Persistent atrial fibrillation without AV block, the proportion of biventricular&#xD;
               pacing is not expected to less than 95%.&#xD;
  &#xD;
            5. Patients participated in any of the other studies at the same time, which may confound&#xD;
               the results of this study.&#xD;
  &#xD;
            6. Pregnancy, planning to become pregnant.&#xD;
  &#xD;
          8. Patients with a history of heart transplantation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Fuwai hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100037</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Xiaofei Li, Doctor</last_name>
        <phone>17801013995</phone>
        <email>lixiaofei0103@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <results_reference>
      <citation>Ferrick AM, Raj SR, Deneke T, Kojodjojo P, Lopez-Cabanillas N, Abe H, Boveda S, Chew DS, Choi JI, Dagres N, Dalal AS, Dechert BE, Frazier-Mills CG, Gilbert O, Han JK, Hewit S, Kneeland C, DeEllen Mirza S, Mittal S, Ricci RP, Runte M, Sinclair S, Alkmim-Teixeira R, Vandenberk B, Varma N. 2023 HRS/EHRA/APHRS/LAHRS expert consensus statement on practical management of the remote device clinic. Heart Rhythm. 2023 Sep;20(9):e92-e144. doi: 10.1016/j.hrthm.2023.03.1525. Epub 2023 May 19.</citation>
      <PMID>37211145</PMID>
    </results_reference>
    <results_reference>
      <citation>Zhang J, Zhang Y, Sun Y, Chen M, Wang Z, Ma C. Success rates, challenges and troubleshooting of left bundle branch area pacing as a cardiac resynchronization therapy for treating patients with heart failure. Front Cardiovasc Med. 2023 Jan 10;9:1062372. doi: 10.3389/fcvm.2022.1062372. eCollection 2022.</citation>
      <PMID>36704478</PMID>
    </results_reference>
    <results_reference>
      <citation>Curila K, Jurak P, Jastrzebski M, Prinzen F, Waldauf P, Halamek J, Vernooy K, Smisek R, Karch J, Plesinger F, Moskal P, Susankova M, Znojilova L, Heckman L, Viscor I, Vondra V, Leinveber P, Osmancik P. Left bundle branch pacing compared to left ventricular septal myocardial pacing increases interventricular dyssynchrony but accelerates left ventricular lateral wall depolarization. Heart Rhythm. 2021 Aug;18(8):1281-1289. doi: 10.1016/j.hrthm.2021.04.025. Epub 2021 Apr 28.</citation>
      <PMID>33930549</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fu Wai Hospital, Beijing, China</investigator_affiliation>
      <investigator_full_name>Li Xiaofei</investigator_full_name>
      <investigator_title>Doctor</investigator_title>
    </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>Undecided</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/NCT05985408
  org study id: 2023-0801
  nct id: NCT05985408
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  To find out whether left ventricular septal pacing (LVSP)-based cardiac resynchronization
        therapy (CRT) is superior to right ventricular apical pacing (RVAP)-based CRT in patients
        with failed left bundle branch pacing at the beginning of chronic heart failure.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: left ventricular ejection fraction (LVEF)
  time frame: 6 months
  description: LVEF evaluated by echocardiography，Bi-plane Simpson's method
  measure: left ventricular ejection fraction (LVEF)
  time frame: 12 months
  description: LVEF evaluated by echocardiography，Bi-plane Simpson's method
  measure: left ventricular end-systolic volume (LVESV)
  time frame: 6 months
  description: LVESV evaluated by echocardiography
  measure: left ventricular end-systolic volume (LVESV)
  time frame: 12 months
  description: LVESV evaluated by echocardiography
  measure: paced QRSd duration.
  time frame: 6 months
  description: QRS duration measurement after the procedure
  measure: paced QRSd duration.
  time frame: 12 months
  description: QRS duration measurement after the procedure
  measure: NT-proBNP
  time frame: 6 months
  description: Serum NT-proBNP level
  measure: NT-proBNP
  time frame: 12 months
  description: Serum NT-proBNP level
  measure: 6-minute hall walk distance
  time frame: 6 months
  description: 6-minute hall walk distance
  measure: 6-minute hall walk distance
  time frame: 12 months
  description: 6-minute hall walk distance
  measure: Heart failure rehospitalization
  time frame: 6 months
  description: Rehospitalization due to the exacerbation of heart failure
  measure: Heart failure rehospitalization
  time frame: 12 months
  description: Rehospitalization due to the exacerbation of heart failure
  measure: Rehospitalization for cardiovascular adverse events
  time frame: 12 months
  description: Rehospitalization for cardiovascular adverse events
  measure: Malignant ventricular arrhythmias
  time frame: 6 months
  description: ICD therapy for ventricular tachycardia or ventricular fibrillation
  measure: Malignant ventricular arrhythmias
  time frame: 12 months
  description: ICD therapy for ventricular tachycardia or ventricular fibrillation
  measure: All cause death
  time frame: 6 months
  description: All cause death events
  measure: All cause death
  time frame: 12 months
  description: All cause death events
  arm group label: LVSP-CRT
  arm group type: Experimental
  description: Patients received LVSP based CRT implantation; LVSP, left ventricular septal pacing; CRT, cardiac resynchronization therapy.
  arm group label: RVAP-CRT
  arm group type: Active Comparator
  description: Patients received RVAP based CRT implantation; RVAP, right ventricular apical pacing; CRT, cardiac resynchronization therapy.
  intervention type: Device
  intervention name: left ventricular septal pacing
  description: For left bundle branch pacing (LBBP) failure cases, use left ventricular septal pacing instead of LBBP; others were same as traditional CRT.
  arm group label: LVSP-CRT
  intervention type: Device
  intervention name: right ventricular apical pacing
  description: For left bundle branch pacing (LBBP) failure cases, use right ventricular apical pacing instead of LBBP; others were same as traditional CRT.
  arm group label: RVAP-CRT
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  facility: 
  contact: 
  country: China
  citation: Ferrick AM, Raj SR, Deneke T, Kojodjojo P, Lopez-Cabanillas N, Abe H, Boveda S, Chew DS, Choi JI, Dagres N, Dalal AS, Dechert BE, Frazier-Mills CG, Gilbert O, Han JK, Hewit S, Kneeland C, DeEllen Mirza S, Mittal S, Ricci RP, Runte M, Sinclair S, Alkmim-Teixeira R, Vandenberk B, Varma N. 2023 HRS/EHRA/APHRS/LAHRS expert consensus statement on practical management of the remote device clinic. Heart Rhythm. 2023 Sep;20(9):e92-e144. doi: 10.1016/j.hrthm.2023.03.1525. Epub 2023 May 19.
  PMID: 37211145
  citation: Zhang J, Zhang Y, Sun Y, Chen M, Wang Z, Ma C. Success rates, challenges and troubleshooting of left bundle branch area pacing as a cardiac resynchronization therapy for treating patients with heart failure. Front Cardiovasc Med. 2023 Jan 10;9:1062372. doi: 10.3389/fcvm.2022.1062372. eCollection 2022.
  PMID: 36704478
  citation: Curila K, Jurak P, Jastrzebski M, Prinzen F, Waldauf P, Halamek J, Vernooy K, Smisek R, Karch J, Plesinger F, Moskal P, Susankova M, Znojilova L, Heckman L, Viscor I, Vondra V, Leinveber P, Osmancik P. Left bundle branch pacing compared to left ventricular septal myocardial pacing increases interventricular dyssynchrony but accelerates left ventricular lateral wall depolarization. Heart Rhythm. 2021 Aug;18(8):1281-1289. doi: 10.1016/j.hrthm.2021.04.025. Epub 2021 Apr 28.
  PMID: 33930549
  responsible party type: Principal Investigator
  investigator affiliation: Fu Wai Hospital, Beijing, China
  investigator full name: Li Xiaofei
  investigator title: Doctor
  mesh term: Heart Failure
  sharing ipd: Undecided