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/NCT06037447</url>
    </required_header>
    <id_info>
      <org_study_id>2022-GSP-GG-19-2</org_study_id>
      <nct_id>NCT06037447</nct_id>
    </id_info>
    <brief_title>Study of Innovative Strategies for Mitral Valve Repair</brief_title>
    <official_title>A Prospective Controlled Study for the Treatment Effect of Different Intervention Strategies for Pediatric Mitral Regurgitation--A Multicenter Prospective Cohort Study of Innovative Strategies for Mitral Valve Repair</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>China National Center for Cardiovascular Diseases</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Shanghai Children's Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Chinese Academy of Medical Sciences, Fuwai Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Guangzhou Women and Children's Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Children's Hospital of Chongqing Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Fuwai Central China Cardiovascular Hospital, Zhengzhou, China</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>China National Center for Cardiovascular Diseases</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational study is to compare the safety and effectiveness of a 3-steps&#xD;
        standardized repair-oriented strategy with annuloplasty only in pediatric patients with mild&#xD;
        to moderate mitral valve regurgitation.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  Can 3-steps standardized repair-oriented strategy improve both left ventricular and&#xD;
             mitral valve function in pediatric patients with mild to moderate mitral valve&#xD;
             regurgitation?&#xD;
  &#xD;
          -  Can surgical complications caused by the 3-steps standardized repair-oriented strategy&#xD;
             be non-inferior (clinically acceptable) to annuloplasty only? Participants will be&#xD;
             assigned to either the Standardized Group (including subvalvular apparatus&#xD;
             rehabilitation (leaflet plication if chordae absent on leaflet margin, mal-connected&#xD;
             chordae resection if chordae mal-connected to leaflet body, papillary muscle splitting&#xD;
             if short chordae or dysplastic or fused papillary muscle etc.), leaflets repair&#xD;
             (leaflets plication if functional leaflet prolapse, leaflet cleft closure and patch&#xD;
             augmentation for anatomical leaflet defect, etc.) and annuloplasty (posterior&#xD;
             annuloplasty for annular dilatation and shallow leaflet coaptation, etc.)) or the&#xD;
             Annuloplasty Group (annuloplasty only during mitral repair surgeries. Additionally,&#xD;
             echocardiography, electrocardiograms, and measurements of N-terminal pro-brain&#xD;
             natriuretic peptide (NT-proBNP) were conducted before the initiation of surgery and at 1&#xD;
             months, 3 months, and 6 months after mitral repair.&#xD;
  &#xD;
        Researchers will compare the Standardized Group and the Annuloplasty Group to see if the&#xD;
        recurrence rate of moderate to severe mitral valve regurgitation, as assessed by&#xD;
        echocardiography after 6 months of surgery, is lower in the former than in the latter.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 1, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 5, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>6 Months</target_duration>
    <primary_outcome>
      <measure>the recurrence rate of moderate to severe mitral valve regurgitation</measure>
      <time_frame>after 6 months of surgery</time_frame>
      <description>During follow-up visits, echocardiographic examination is conducted to measure the degree of mitral valve regurgitation. If it falls within the moderate to severe range, it is recorded as a recurrence.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Improvement in symptoms</measure>
      <time_frame>after 6 months of surgery</time_frame>
      <description>Based on patient and caregiver descriptions, if symptoms such as chest discomfort, shortness of breath, and delayed development show improvement following physical activity, it is recorded as an improvement in symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in left ventricular function</measure>
      <time_frame>after 6 months of surgery</time_frame>
      <description>Based on the echocardiogram, measurements are taken for left ventricular ejection fraction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in left ventricular function</measure>
      <time_frame>after 6 months of surgery</time_frame>
      <description>Based on the echocardiogram, measurements are taken for left ventricular end-diastolic diameter.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>NT-proBNP level</measure>
      <time_frame>after 6 months of surgery</time_frame>
      <description>The trend in NT-proBNP levels.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence rate of surgical complications</measure>
      <time_frame>after 6 months of surgery</time_frame>
      <description>Incidence rate of surgical complications, including infection, low cardiac output, arrhythmia, cardiac insufficiency, delayed sternal closure, thromboembolism and bleeding events, neurological complications(stroke, seizures and intracerebral hemorrhage).</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">256</enrollment>
    <condition>Congenital Mitral Insufficiency</condition>
    <arm_group>
      <arm_group_label>Standardized Group</arm_group_label>
      <description>Patients in this group will undergo standardized strategy during mitral repair surgeries, including subvalvular apparatus rehabilitation, leaflets repair and annuloplasty.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Annuloplasty Group</arm_group_label>
      <description>Patients in this group will undergo annuloplasty only during mitral repair surgeries.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>3-steps standardized repair-oriented strategy</intervention_name>
      <description>3-steps standardized repair-oriented strategy, including subvalvular apparatus rehabilitation (leaflet plication if chordae absent on leaflet margin, mal-connected chordae resection if chordae mal-connected to leaflet body, papillary muscle splitting if short chordae or dysplastic or fused papillary muscle etc.), leaflets repair (leaflets plication if functional leaflet prolapse, leaflet cleft closure and patch augmentation for anatomical leaflet defect, etc.) and annuloplasty (posterior annuloplasty for annular dilatation and shallow leaflet coaptation, etc.)</description>
      <arm_group_label>Standardized Group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Children under the age of 14 with moderate to severe mitral valve regurgitation&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  &lt; 14 years old&#xD;
  &#xD;
            -  had not undertake mitral valve surgery before&#xD;
  &#xD;
            -  moderate to severe mitral regurgitation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  moderate to severe mitral regurgitation which concommitant with other cardiac&#xD;
               malformation which can not be correct or can only perform palliative surgery&#xD;
  &#xD;
            -  concommitant with mitral stenosis&#xD;
  &#xD;
            -  ischemic mitral regurgitation (for example, concommitant with anomalous origin of&#xD;
               coronary artery)&#xD;
  &#xD;
            -  Barlow syndrome&#xD;
  &#xD;
            -  dysplasia of mitral leaflet&#xD;
  &#xD;
            -  complete/Partial endocardial cushion defect&#xD;
  &#xD;
            -  common atrioventricular valve&#xD;
  &#xD;
            -  atrioventricular common channel&#xD;
  &#xD;
            -  cardiomyopathy&#xD;
  &#xD;
            -  other mitral valve surgery contraindications&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>14 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Shoujun Li, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Fuwai Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kai Ma, PhD</last_name>
      <phone>+86 15901428497</phone>
      <email>drmakaifw@yahoo.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Zheng Dou, PhD</last_name>
      <phone>+86 18810673618</phone>
      <email>drdouzheng@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Fuwai hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100037</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Shoujun Li, MD</last_name>
        <phone>+86 13501071589</phone>
        <email>drlishoujunfw@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>China National Center for Cardiovascular Diseases</investigator_affiliation>
      <investigator_full_name>Shoujun Li</investigator_full_name>
      <investigator_title>Director of Congenital Heart Surgery Center</investigator_title>
    </responsible_party>
    <keyword>congenital heart disease</keyword>
    <keyword>mitral regurgitation</keyword>
    <keyword>mitral valve repair</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mitral Valve Insufficiency</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/NCT06037447
  org study id: 2022-GSP-GG-19-2
  nct id: NCT06037447
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The goal of this observational study is to compare the safety and effectiveness of a 3-steps
        standardized repair-oriented strategy with annuloplasty only in pediatric patients with mild
        to moderate mitral valve regurgitation.
  
        The main questions it aims to answer are:
  
          -  Can 3-steps standardized repair-oriented strategy improve both left ventricular and
             mitral valve function in pediatric patients with mild to moderate mitral valve
             regurgitation?
  
          -  Can surgical complications caused by the 3-steps standardized repair-oriented strategy
             be non-inferior (clinically acceptable) to annuloplasty only? Participants will be
             assigned to either the Standardized Group (including subvalvular apparatus
             rehabilitation (leaflet plication if chordae absent on leaflet margin, mal-connected
             chordae resection if chordae mal-connected to leaflet body, papillary muscle splitting
             if short chordae or dysplastic or fused papillary muscle etc.), leaflets repair
             (leaflets plication if functional leaflet prolapse, leaflet cleft closure and patch
             augmentation for anatomical leaflet defect, etc.) and annuloplasty (posterior
             annuloplasty for annular dilatation and shallow leaflet coaptation, etc.)) or the
             Annuloplasty Group (annuloplasty only during mitral repair surgeries. Additionally,
             echocardiography, electrocardiograms, and measurements of N-terminal pro-brain
             natriuretic peptide (NT-proBNP) were conducted before the initiation of surgery and at 1
             months, 3 months, and 6 months after mitral repair.
  
        Researchers will compare the Standardized Group and the Annuloplasty Group to see if the
        recurrence rate of moderate to severe mitral valve regurgitation, as assessed by
        echocardiography after 6 months of surgery, is lower in the former than in the latter.
  observational model: Cohort
  time perspective: Prospective
  measure: the recurrence rate of moderate to severe mitral valve regurgitation
  time frame: after 6 months of surgery
  description: During follow-up visits, echocardiographic examination is conducted to measure the degree of mitral valve regurgitation. If it falls within the moderate to severe range, it is recorded as a recurrence.
  measure: Improvement in symptoms
  time frame: after 6 months of surgery
  description: Based on patient and caregiver descriptions, if symptoms such as chest discomfort, shortness of breath, and delayed development show improvement following physical activity, it is recorded as an improvement in symptoms.
  measure: Change in left ventricular function
  time frame: after 6 months of surgery
  description: Based on the echocardiogram, measurements are taken for left ventricular ejection fraction.
  measure: Change in left ventricular function
  time frame: after 6 months of surgery
  description: Based on the echocardiogram, measurements are taken for left ventricular end-diastolic diameter.
  measure: NT-proBNP level
  time frame: after 6 months of surgery
  description: The trend in NT-proBNP levels.
  measure: Incidence rate of surgical complications
  time frame: after 6 months of surgery
  description: Incidence rate of surgical complications, including infection, low cardiac output, arrhythmia, cardiac insufficiency, delayed sternal closure, thromboembolism and bleeding events, neurological complications(stroke, seizures and intracerebral hemorrhage).
  arm group label: Standardized Group
  description: Patients in this group will undergo standardized strategy during mitral repair surgeries, including subvalvular apparatus rehabilitation, leaflets repair and annuloplasty.
  arm group label: Annuloplasty Group
  description: Patients in this group will undergo annuloplasty only during mitral repair surgeries.
  intervention type: Procedure
  intervention name: 3-steps standardized repair-oriented strategy
  description: 3-steps standardized repair-oriented strategy, including subvalvular apparatus rehabilitation (leaflet plication if chordae absent on leaflet margin, mal-connected chordae resection if chordae mal-connected to leaflet body, papillary muscle splitting if short chordae or dysplastic or fused papillary muscle etc.), leaflets repair (leaflets plication if functional leaflet prolapse, leaflet cleft closure and patch augmentation for anatomical leaflet defect, etc.) and annuloplasty (posterior annuloplasty for annular dilatation and shallow leaflet coaptation, etc.)
  arm group label: Standardized Group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 14 Years
  healthy volunteers: No
  last name: Shoujun Li, MD
  role: Study Chair
  affiliation: Fuwai Hospital
  last name: Kai Ma, PhD
  phone: +86 15901428497
  email: drmakaifw@yahoo.com
  last name: Zheng Dou, PhD
  phone: +86 18810673618
  email: drdouzheng@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: China National Center for Cardiovascular Diseases
  investigator full name: Shoujun Li
  investigator title: Director of Congenital Heart Surgery Center
  mesh term: Mitral Valve Insufficiency
  sharing ipd: No