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/NCT05977257</url>
    </required_header>
    <id_info>
      <org_study_id>VITAL-2023-192R</org_study_id>
      <nct_id>NCT05977257</nct_id>
    </id_info>
    <brief_title>VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL）</brief_title>
    <acronym>VITAL</acronym>
    <official_title>VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL）</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai MicroPort CardioFlow Medtech Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai MicroPort CardioFlow Medtech Co., Ltd.</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>
        This study is an observational study to evaluate the long-term safety and effectiveness of&#xD;
        the valve system.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve&#xD;
        System pre-market trial (Protocol No. valve -2014-04) in 4 designated research institutions,&#xD;
        and follow-up from 6 to 10 years after the procedure, To evaluate the long-term safety and&#xD;
        effectiveness of the valve system.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 30, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2028</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2025</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>All cause mortality</measure>
      <time_frame>7years after the operation</time_frame>
      <description>rate of all cause mortality</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cardiac death</measure>
      <time_frame>6 years, 7 years, 8 years, 9 years and 10 years after the operation</time_frame>
      <description>rate of Cardiac death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stroke</measure>
      <time_frame>6 years, 7 years, 8 years, 9 years and 10 years after the operation</time_frame>
      <description>rate of stroke</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>valve-related rehospitalization</measure>
      <time_frame>6 years, 7 years, 8 years, 9 years and 10 years after the operation</time_frame>
      <description>rate of valve-related rehospitalization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serious Adverse Event</measure>
      <time_frame>6 years, 7 years, 8 years, 9 years and 10 years after the operation</time_frame>
      <description>rate of Serious Adverse Event</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood pressure</measure>
      <time_frame>6 years, 7 years, 8 years, 9 years and 10 years after the operation</time_frame>
      <description>Systolic and Diastolic Blood Pressure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The 12-Item Short Form Health Survey (SF-12)</measure>
      <time_frame>6years, 7years, 8 years, 9 years and 10 years after the operation</time_frame>
      <description>Scores range from 0 to 100, higher scores are better</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean transvalvular pressure gradient</measure>
      <time_frame>7years,and 10 years after the operation</time_frame>
      <description>Transthoracic Echocardiogram test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effective orifice area</measure>
      <time_frame>7years,and 10 years after the operation</time_frame>
      <description>Transthoracic Echocardiogram test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Peak velocity</measure>
      <time_frame>7years,and 10 years after the operation</time_frame>
      <description>Transthoracic Echocardiogram test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>class of Paravalvular leak</measure>
      <time_frame>7years,and 10 years after the operation</time_frame>
      <description>Transthoracic Echocardiogram test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>class of Aortic regurgitation</measure>
      <time_frame>7years,and 10 years after the operation</time_frame>
      <description>Transthoracic Echocardiogram test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>New York Heart Association Class for heart function</measure>
      <time_frame>7years,and 10 years after the operation</time_frame>
      <description>NYHA class</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Kansas City Cardiomyopathy Questionnaire</measure>
      <time_frame>7years,and 10 years after the operation</time_frame>
      <description>Kansas City Cardiomyopathy Questionnaire(score 0-100), higher scores are better</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Natriuretic peptide tests ( NT Pro-BNP or BNP)</measure>
      <time_frame>7years,and 10 years after the operation</time_frame>
      <description>blood test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>moderate and severe structural valve deterioration SVD</measure>
      <time_frame>7years,and 10 years after the operation</time_frame>
      <description>Transthoracic Echocardiogram test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>bioprosthetic valve failure，BVF</measure>
      <time_frame>7years,and 10 years after the operation</time_frame>
      <description>Transthoracic Echocardiogram test</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All cause mortality</measure>
      <time_frame>6 years, 8 years, 9 years and 10 years after the operation</time_frame>
      <description>rate of all cause mortality</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">89</enrollment>
    <condition>Aortic Valve Disease</condition>
    <condition>Aortic Valve Stenosis</condition>
    <arm_group>
      <arm_group_label>Non Interventional long term safety follow up</arm_group_label>
      <description>Non Interventional long term safety follow up</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>VitaFlow® Transcatheter Aortic Valve Replacement System</intervention_name>
      <description>This study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve System pre-market trial</description>
      <arm_group_label>Non Interventional long term safety follow up</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who have participated in the VitaFlow® transcatheter aortic valve system&#xD;
          pre-market trial&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Must meet 1, 2, 3, 4 or 1, 5 to be selected:&#xD;
  &#xD;
                 1. Patients who have participated in the VitaFlow® transcatheter aortic valve system&#xD;
                    pre-market trial in the 4 designated research institutions*;&#xD;
  &#xD;
                 2. Be able to get in touch with the patient or his legal guardian/relative;&#xD;
  &#xD;
                 3. Patients who can understand the purpose and nature of the follow-up of this&#xD;
                    study, and are willing to cooperate with the follow-up and provide follow-up&#xD;
                    information;&#xD;
  &#xD;
                 4. Sign the informed consent form;&#xD;
  &#xD;
                 5. Patients who are known to have died.&#xD;
  &#xD;
                      -  4 research institutions: Zhongshan Hospital Fudan University, Second&#xD;
                         Affiliated Hospital of Zhejiang University School of Medicine, West China&#xD;
                         Hospital of Sichuan University and Fuwai Hospital.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Participate in clinical trials of other drugs or medical devices and have not yet&#xD;
               reached the primary endpoint;&#xD;
  &#xD;
            2. The investigator judges that the patient's compliance is poor and the study cannot be&#xD;
               completed as required.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Daxin Zhou</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fudan University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>JIATONG ZHANG</last_name>
      <phone>+8617797187661</phone>
      <email>JiaTong.Zhang@microport.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Fuwai CVD Hospital of Chinese Academy of Medical Sciences</name>
        <address>
          <city>Beijing</city>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yongjian Wu</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>West China Hospital, Sichuan University</name>
        <address>
          <city>Chengdu</city>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yuan Feng</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Second Affiliated Hospital Zhejiang University School of Medicine</name>
        <address>
          <city>Hangzhou</city>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Jianan Wang</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Zhongshan Hospital Fudan University</name>
        <address>
          <city>Shanghai</city>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Daxin Zhou</last_name>
      </contact>
      <investigator>
        <last_name>Daxin Zhou</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 10, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Aortic Valve Stenosis</mesh_term>
      <mesh_term>Aortic Valve Disease</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/NCT05977257
  org study id: VITAL-2023-192R
  nct id: NCT05977257
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study is an observational study to evaluate the long-term safety and effectiveness of
        the valve system.
  This study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve
        System pre-market trial (Protocol No. valve -2014-04) in 4 designated research institutions,
        and follow-up from 6 to 10 years after the procedure, To evaluate the long-term safety and
        effectiveness of the valve system.
  observational model: Cohort
  time perspective: Prospective
  measure: All cause mortality
  time frame: 7years after the operation
  description: rate of all cause mortality
  measure: Cardiac death
  time frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
  description: rate of Cardiac death
  measure: Stroke
  time frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
  description: rate of stroke
  measure: valve-related rehospitalization
  time frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
  description: rate of valve-related rehospitalization
  measure: Serious Adverse Event
  time frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
  description: rate of Serious Adverse Event
  measure: Blood pressure
  time frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
  description: Systolic and Diastolic Blood Pressure
  measure: The 12-Item Short Form Health Survey (SF-12)
  time frame: 6years, 7years, 8 years, 9 years and 10 years after the operation
  description: Scores range from 0 to 100, higher scores are better
  measure: Mean transvalvular pressure gradient
  time frame: 7years,and 10 years after the operation
  description: Transthoracic Echocardiogram test
  measure: Effective orifice area
  time frame: 7years,and 10 years after the operation
  description: Transthoracic Echocardiogram test
  measure: Peak velocity
  time frame: 7years,and 10 years after the operation
  description: Transthoracic Echocardiogram test
  measure: class of Paravalvular leak
  time frame: 7years,and 10 years after the operation
  description: Transthoracic Echocardiogram test
  measure: class of Aortic regurgitation
  time frame: 7years,and 10 years after the operation
  description: Transthoracic Echocardiogram test
  measure: New York Heart Association Class for heart function
  time frame: 7years,and 10 years after the operation
  description: NYHA class
  measure: Kansas City Cardiomyopathy Questionnaire
  time frame: 7years,and 10 years after the operation
  description: Kansas City Cardiomyopathy Questionnaire(score 0-100), higher scores are better
  measure: Natriuretic peptide tests ( NT Pro-BNP or BNP)
  time frame: 7years,and 10 years after the operation
  description: blood test
  measure: moderate and severe structural valve deterioration SVD
  time frame: 7years,and 10 years after the operation
  description: Transthoracic Echocardiogram test
  measure: bioprosthetic valve failure，BVF
  time frame: 7years,and 10 years after the operation
  description: Transthoracic Echocardiogram test
  measure: All cause mortality
  time frame: 6 years, 8 years, 9 years and 10 years after the operation
  description: rate of all cause mortality
  arm group label: Non Interventional long term safety follow up
  description: Non Interventional long term safety follow up
  intervention type: Device
  intervention name: VitaFlow® Transcatheter Aortic Valve Replacement System
  description: This study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve System pre-market trial
  arm group label: Non Interventional long term safety follow up
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Daxin Zhou
  role: Principal Investigator
  affiliation: Fudan University
  last name: JIATONG ZHANG
  phone: +8617797187661
  email: JiaTong.Zhang@microport.com
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  investigator: 
  country: China
  responsible party type: Sponsor
  mesh term: Aortic Valve Stenosis
  mesh term: Aortic Valve Disease