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/NCT06003478</url>
    </required_header>
    <id_info>
      <org_study_id>KY20232228-C-1</org_study_id>
      <nct_id>NCT06003478</nct_id>
    </id_info>
    <brief_title>The Safety and Influencing Factors of Liwen Procedure in The Treatment of Hypertrophic Cardiomyopathy</brief_title>
    <official_title>The Safety and Influencing Factors of Ultrasound-guided Percutaneous Intramyocardial Septal Radiofrequency Ablation (Liwen Procedure) in The Treatment of Hypertrophic Cardiomyopathy</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>
        Liwen procedure is generally safe and effective in treating hypertrophic cardiomyopathy, but&#xD;
        a small proportion of patients have complications after the operation.&#xD;
  &#xD;
        The goal of this observational study is to explore the incidence of postoperative&#xD;
        complications of the Liwen procedure in hypertrophic cardiomyopathy patients underwent Liwen&#xD;
        procedure in Xijing Hospital. The main question it aims to answer are:&#xD;
  &#xD;
          -  What is the incidence of complications in HCM patients underwent Liwen Procedure during&#xD;
             postoperative hospitalization and a short-term follow-up period?&#xD;
  &#xD;
          -  What is the relevant factors of complications in HCM patients who underwent Liwen&#xD;
             Procedure during postoperative hospitalization and short-term follow-up period? Can the&#xD;
             complications of surgical patients during postoperative hospitalization be predicted?&#xD;
             Participants have been evaluated using a variety of medical examinations before they&#xD;
             underwent Liwen Procedure. Variants collected from medical examination and case history&#xD;
             were used to analyze the association with each postoperative complication.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 21, 2023</start_date>
    <completion_date type="Anticipated">May 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 30, 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>Postoperative Complications During Hospitalization</measure>
      <time_frame>From date of procedure until the date of first documented occurrence of symptomatic hypotension, or date of dischargement from hospital, assessed up to 1 month.</time_frame>
      <description>Complications including symptomatic postoperative hypotension observed during hospitalization after PIMSRA. The symptomatic postoperative hypotension is defined as systolic blood pressure lower than 90 mmHg documented by invasive or noninvasive blood pressure measurement accompanied by symptoms including dizziness, and cephalalgia, without regard to the duration of hypotension.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Postoperative Complications During Follow-up Period</measure>
      <time_frame>From date of dischargement until the date of first diagnosis of chronic hypotension or orthostatic hypotension, assessed up to 1 year.</time_frame>
      <description>Complications including chronic hypotension or orthostatic hypotension observed during the follow-up period. Chronic hypotension is defined as mean systolic/diastolic blood pressure lower than 90/60 mmHg documented by ambulatory blood pressure monitoring of more than 23 hours. Orthostatic hypotension is defined as a frop of standing and mean sitting SBP ≥20 mm Hg or diastolic BP ≥10 mm Hg, with complaining of dizziness or fall.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">486</enrollment>
    <condition>Hypertrophic Obstructive Cardiomyopathy</condition>
    <arm_group>
      <arm_group_label>Hypertrophic Obstructive Cardiomyopathy Patients</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 for up to 12 min and the ablation power is gradually increased 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</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 October to 2023 July.&#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>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 20, 2023</last_update_submitted>
    <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 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>
    <keyword>Cardiomyopathy, hypertrophic</keyword>
    <keyword>Hypotension</keyword>
    <keyword>Postoperative Complication</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiomyopathies</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/NCT06003478
  org study id: KY20232228-C-1
  nct id: NCT06003478
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Liwen procedure is generally safe and effective in treating hypertrophic cardiomyopathy, but
        a small proportion of patients have complications after the operation.
  
        The goal of this observational study is to explore the incidence of postoperative
        complications of the Liwen procedure in hypertrophic cardiomyopathy patients underwent Liwen
        procedure in Xijing Hospital. The main question it aims to answer are:
  
          -  What is the incidence of complications in HCM patients underwent Liwen Procedure during
             postoperative hospitalization and a short-term follow-up period?
  
          -  What is the relevant factors of complications in HCM patients who underwent Liwen
             Procedure during postoperative hospitalization and short-term follow-up period? Can the
             complications of surgical patients during postoperative hospitalization be predicted?
             Participants have been evaluated using a variety of medical examinations before they
             underwent Liwen Procedure. Variants collected from medical examination and case history
             were used to analyze the association with each postoperative complication.
  observational model: Cohort
  time perspective: Retrospective
  measure: Postoperative Complications During Hospitalization
  time frame: From date of procedure until the date of first documented occurrence of symptomatic hypotension, or date of dischargement from hospital, assessed up to 1 month.
  description: Complications including symptomatic postoperative hypotension observed during hospitalization after PIMSRA. The symptomatic postoperative hypotension is defined as systolic blood pressure lower than 90 mmHg documented by invasive or noninvasive blood pressure measurement accompanied by symptoms including dizziness, and cephalalgia, without regard to the duration of hypotension.
  measure: Postoperative Complications During Follow-up Period
  time frame: From date of dischargement until the date of first diagnosis of chronic hypotension or orthostatic hypotension, assessed up to 1 year.
  description: Complications including chronic hypotension or orthostatic hypotension observed during the follow-up period. Chronic hypotension is defined as mean systolic/diastolic blood pressure lower than 90/60 mmHg documented by ambulatory blood pressure monitoring of more than 23 hours. Orthostatic hypotension is defined as a frop of standing and mean sitting SBP ≥20 mm Hg or diastolic BP ≥10 mm Hg, with complaining of dizziness or fall.
  arm group label: Hypertrophic Obstructive Cardiomyopathy Patients
  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 for up to 12 min and the ablation power is gradually increased 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
  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: Cardiomyopathy, Hypertrophic
  mesh term: Hypertrophy