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/NCT06031519</url>
    </required_header>
    <id_info>
      <org_study_id>KY-20232259-C-1</org_study_id>
      <nct_id>NCT06031519</nct_id>
    </id_info>
    <brief_title>Impact of Liwen Procedure in Obstructive Hypertrophic Cardiomyopathy on Arrhythmias</brief_title>
    <official_title>Impact of Percutaneous Intramyocardial Septal Radiofrequency Ablation in Obstructive Hypertrophic Cardiomyopathy on Arrhythmias</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Xijing Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Xijing 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>
        The goal of this observational study is to learn about the occurrence of various arrhythmias&#xD;
        ( tachyarrhythmia and bradyarrhythmia ) during or after Percutaneous Intramyocardial Septal&#xD;
        Radiofrequency Ablation. The main questions it aims to answer are:&#xD;
  &#xD;
          -  To investigate the occurrence of various arrhythmias ( tachyarrhythmia and&#xD;
             bradyarrhythmia ) during procedure and its relationship with clinical characteristics&#xD;
             and procedural parameters&#xD;
  &#xD;
          -  To analyze the changes of 12-lead electrocardiogram and 24-hour dynamic&#xD;
             electrocardiogram before and after Percutaneous Intramyocardial Septal Radiofrequency&#xD;
             Ablation and their relationships with clinical characteristics and procedural parameters&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">August 22, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2024</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>All-cause and cardiovascular mortality</measure>
      <time_frame>From date of procedure until the date of first occurrence of outcome, assessed up to 1 years</time_frame>
      <description>All-cause and cardiovascular mortality (defined as sudden cardiac death, Heart Failure-related death, and heart transplant) were the primary outcomes.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Ventricular tacharrhythmia composite outcome</measure>
      <time_frame>From date of procedure until the date of first occurrence of outcome, assessed up to 1 years</time_frame>
      <description>Unexplained syncope, resuscitated cardiac arrests, or appropriate implantable cardioverter-defibrillator charge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Arrhythmia</measure>
      <time_frame>From date of procedure until the date of first occurrence of outcome, assessed up to 1 years</time_frame>
      <description>Complete heart block, new permanent pacemaker implantation, non-sustained ventricular tachycardia, sustained ventricular tachycardia, left bundle branch block, right bundle branch block, premature ventricular contractions burden more than 10% monitored by Holter.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">350</enrollment>
    <condition>Hypertrophic Cardiomyopathy</condition>
    <condition>Arrhythmia</condition>
    <arm_group>
      <arm_group_label>Hypertrophic Obstructive Cardiomyopathy Patients underwent Liwen Procedure</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Percutaneous Intramyocardial Septal Radiofrequency Ablation for hypertrophic obstructive cardiomyopathy (Liwen Procedure)</intervention_name>
      <description>Under transthoracic echocardiography (TTE) guidance, the puncture site is positioned at the apex. A guiding line is applied along the septal long axis and the radiofrequency ablation electrode needle(17G, Cool-tip™ RF Ablation System and Switching Controller; Medtronic, Minneapolis, MN, USA) pierced towards the hypertrophic anterior interventricular septum (AIVS) 8-10 mm from the subaortic valve. Each ablation lasts up to 12 min, and the ablation power gradually increases from 30-40W. Then, the ablation needle is withdrawn 10 mm to prepare for the next application. Overall, 3-4 applications are performed in each patient. The ablation creates an area of thermal coagulative myocardial necrosis that appears as a hyperechogenic reflection detected by TTE. If deemed necessary, we repeat the procedure at the posterior interventricular septum (PIVS).</description>
      <arm_group_label>Hypertrophic Obstructive Cardiomyopathy Patients underwent Liwen Procedure</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who are diagnosed with obstructive HCM and with drug-refractory symptoms underwent&#xD;
          Liwen Procedure in Xijing Hospital from 2016 to 2023.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subject with symptoms that limit daily activities (New York Heart Association&#xD;
               functional class &gt;II, exercise-induced syncope) despite adequate medical treatment or&#xD;
               when medical treatment is not tolerated&#xD;
  &#xD;
            2. Subject with a peak LVOT gradient≥50 mm Hg&#xD;
  &#xD;
            3. Subject volunteers for the Liwen procedure and received the procedure at the&#xD;
               Hypertrophic Cardiomyopathy Center of Xijing Hospital.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subject with a peak instantaneous Doppler LVOT gradient of &lt;50 mm Hg&#xD;
  &#xD;
            2. Subject with an indication for septal reduction therapy and other lesions requiring&#xD;
               surgical intervention (e.g., mitral valve repair/replacement and papillary muscle&#xD;
               intervention)&#xD;
  &#xD;
            3. Subject has end-stage heart failure&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Ultrasound Medicine Department of Xijing Hospital, Fourth Military Medical University</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <zip>710032</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Xijing Hospital</investigator_affiliation>
      <investigator_full_name>Liu Liwen</investigator_full_name>
      <investigator_title>Director</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiomyopathies</mesh_term>
      <mesh_term>Arrhythmias, Cardiac</mesh_term>
      <mesh_term>Cardiomyopathy, Hypertrophic</mesh_term>
      <mesh_term>Hypertrophy</mesh_term>
    </condition_browse>
    <!-- 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/NCT06031519
  org study id: KY-20232259-C-1
  nct id: NCT06031519
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to learn about the occurrence of various arrhythmias
        ( tachyarrhythmia and bradyarrhythmia ) during or after Percutaneous Intramyocardial Septal
        Radiofrequency Ablation. The main questions it aims to answer are:
  
          -  To investigate the occurrence of various arrhythmias ( tachyarrhythmia and
             bradyarrhythmia ) during procedure and its relationship with clinical characteristics
             and procedural parameters
  
          -  To analyze the changes of 12-lead electrocardiogram and 24-hour dynamic
             electrocardiogram before and after Percutaneous Intramyocardial Septal Radiofrequency
             Ablation and their relationships with clinical characteristics and procedural parameters
  observational model: Cohort
  time perspective: Retrospective
  measure: All-cause and cardiovascular mortality
  time frame: From date of procedure until the date of first occurrence of outcome, assessed up to 1 years
  description: All-cause and cardiovascular mortality (defined as sudden cardiac death, Heart Failure-related death, and heart transplant) were the primary outcomes.
  measure: Ventricular tacharrhythmia composite outcome
  time frame: From date of procedure until the date of first occurrence of outcome, assessed up to 1 years
  description: Unexplained syncope, resuscitated cardiac arrests, or appropriate implantable cardioverter-defibrillator charge.
  measure: Arrhythmia
  time frame: From date of procedure until the date of first occurrence of outcome, assessed up to 1 years
  description: Complete heart block, new permanent pacemaker implantation, non-sustained ventricular tachycardia, sustained ventricular tachycardia, left bundle branch block, right bundle branch block, premature ventricular contractions burden more than 10% monitored by Holter.
  arm group label: Hypertrophic Obstructive Cardiomyopathy Patients underwent Liwen Procedure
  intervention type: Procedure
  intervention name: Percutaneous Intramyocardial Septal Radiofrequency Ablation for hypertrophic obstructive cardiomyopathy (Liwen Procedure)
  description: Under transthoracic echocardiography (TTE) guidance, the puncture site is positioned at the apex. A guiding line is applied along the septal long axis and the radiofrequency ablation electrode needle(17G, Cool-tip™ RF Ablation System and Switching Controller; Medtronic, Minneapolis, MN, USA) pierced towards the hypertrophic anterior interventricular septum (AIVS) 8-10 mm from the subaortic valve. Each ablation lasts up to 12 min, and the ablation power gradually increases from 30-40W. Then, the ablation needle is withdrawn 10 mm to prepare for the next application. Overall, 3-4 applications are performed in each patient. The ablation creates an area of thermal coagulative myocardial necrosis that appears as a hyperechogenic reflection detected by TTE. If deemed necessary, we repeat the procedure at the posterior interventricular septum (PIVS).
  arm group label: Hypertrophic Obstructive Cardiomyopathy Patients underwent Liwen Procedure
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Xijing Hospital
  investigator full name: Liu Liwen
  investigator title: Director
  mesh term: Cardiomyopathies
  mesh term: Arrhythmias, Cardiac
  mesh term: Cardiomyopathy, Hypertrophic
  mesh term: Hypertrophy