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/NCT06041308</url>
    </required_header>
    <id_info>
      <org_study_id>202012072RIND</org_study_id>
      <nct_id>NCT06041308</nct_id>
    </id_info>
    <brief_title>Bioprothetic Valve Versus Mechanical Valve of Bioprothetic Valve Versus Mechanical Valve</brief_title>
    <official_title>Long-term Outcomes of Bioprothetic Valve Versus Mechanical Valve</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Taiwan University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Taiwan University 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>
        Long-term follow-up of valve surgery is essential in all cardiac surgeries and is the most&#xD;
        commonly discussed indicator. The choice of valves has evolved over the past 30 years,&#xD;
        offering two options: biological valves and mechanical valves. Biological valves have seen&#xD;
        advancements in the last 15 years, including new processes and improved valve preservation&#xD;
        methods. The question of whether these new process valves offer better long-term&#xD;
        effectiveness has become a hot research topic in recent years.&#xD;
  &#xD;
        Mechanical valves have a longer lifespan, but the need for long-term anticoagulant use to&#xD;
        prevent mechanical valve thrombosis has raised concerns about anticoagulant side effects,&#xD;
        abnormal clotting function, and bleeding. Biological valves, on the other hand, do not&#xD;
        require long-term anticoagulation and only necessitate 2-3 months of anticoagulant treatment.&#xD;
        However, the risk of biological valve degeneration results in an average lifespan of 10 to 20&#xD;
        years, which cannot match the durability of mechanical valves. This is the drawback of using&#xD;
        biological valves.&#xD;
  &#xD;
        Therefore, we hope to utilize the hospital's integrated medical database and the long-term&#xD;
        National Health Insurance database for tracking. We aim to observe valve performance in&#xD;
        different patient groups, such as young people, the elderly, patients on dialysis, those with&#xD;
        rheumatic autoimmune diseases, and those taking specific medications, among others.&#xD;
  &#xD;
        In this study, we aim to use data identified through the hospital's integrated medical&#xD;
        database and National Health Insurance database to explore the long-term performance and&#xD;
        benefits of biological and mechanical valves. This research aims to provide more&#xD;
        recommendations and references for valve replacement in different patient populations.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 16, 2021</start_date>
    <completion_date type="Anticipated">December 1, 2025</completion_date>
    <primary_completion_date type="Actual">February 17, 2022</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>Mitral Valve Surgery in Dialysis Patients: Repair or Replacement</measure>
      <time_frame>1998-2019</time_frame>
      <description>Mitral Valve Surgery Selection in Dialysis Patients</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">30000</enrollment>
    <condition>Long-term Outcomes of Bioprothetic Valve Versus Mechanical Valve</condition>
    <arm_group>
      <arm_group_label>Bioprothetic valve</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Mechanical valve</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>valve</intervention_name>
      <description>bioprothetic valve versus mechanical valve</description>
      <arm_group_label>Bioprothetic valve</arm_group_label>
      <arm_group_label>Mechanical valve</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          A total of 30,000 individuals (including this institution and other domestic units).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:This is a retrospective study, and we plan to utilize data from the&#xD;
          hospital's integrated medical database and the National Health Insurance database from&#xD;
          January 2007 to December 2019. We will identify all patients within the data who were&#xD;
          diagnosed with valve diseases and underwent valve replacement surgery.&#xD;
  &#xD;
          -&#xD;
  &#xD;
          Exclusion Criteria:Individuals under 20 years of age.&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>20 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Nai-Hsin Chi</last_name>
      <phone>886-2-23123456</phone>
      <phone_ext>265081</phone_ext>
      <email>chinaihsin@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>National Taiwan University Hospital</name>
        <address>
          <city>Taipei</city>
          <zip>100</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nai-Hsin Chi, M.D./Ph.D.</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>March 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- 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/NCT06041308
  org study id: 202012072RIND
  nct id: NCT06041308
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Long-term follow-up of valve surgery is essential in all cardiac surgeries and is the most
        commonly discussed indicator. The choice of valves has evolved over the past 30 years,
        offering two options: biological valves and mechanical valves. Biological valves have seen
        advancements in the last 15 years, including new processes and improved valve preservation
        methods. The question of whether these new process valves offer better long-term
        effectiveness has become a hot research topic in recent years.
  
        Mechanical valves have a longer lifespan, but the need for long-term anticoagulant use to
        prevent mechanical valve thrombosis has raised concerns about anticoagulant side effects,
        abnormal clotting function, and bleeding. Biological valves, on the other hand, do not
        require long-term anticoagulation and only necessitate 2-3 months of anticoagulant treatment.
        However, the risk of biological valve degeneration results in an average lifespan of 10 to 20
        years, which cannot match the durability of mechanical valves. This is the drawback of using
        biological valves.
  
        Therefore, we hope to utilize the hospital's integrated medical database and the long-term
        National Health Insurance database for tracking. We aim to observe valve performance in
        different patient groups, such as young people, the elderly, patients on dialysis, those with
        rheumatic autoimmune diseases, and those taking specific medications, among others.
  
        In this study, we aim to use data identified through the hospital's integrated medical
        database and National Health Insurance database to explore the long-term performance and
        benefits of biological and mechanical valves. This research aims to provide more
        recommendations and references for valve replacement in different patient populations.
  observational model: Cohort
  time perspective: Retrospective
  measure: Mitral Valve Surgery in Dialysis Patients: Repair or Replacement
  time frame: 1998-2019
  description: Mitral Valve Surgery Selection in Dialysis Patients
  arm group label: Bioprothetic valve
  arm group label: Mechanical valve
  intervention type: Other
  intervention name: valve
  description: bioprothetic valve versus mechanical valve
  arm group label: Bioprothetic valve
  arm group label: Mechanical valve
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 20 Years
  healthy volunteers: No
  last name: Nai-Hsin Chi
  phone: 886-2-23123456
  phone ext: 265081
  email: chinaihsin@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Taiwan
  responsible party type: Sponsor