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/NCT06011148</url>
    </required_header>
    <id_info>
      <org_study_id>CCH803</org_study_id>
      <nct_id>NCT06011148</nct_id>
    </id_info>
    <brief_title>Clinical Data Collection on Perceval S Sutureless Prosthetic Aortic Valve in the Chinese Population</brief_title>
    <official_title>Clinical Data Collection on Perceval S Sutureless Prosthetic Aortic Valve in the Chinese Population</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Corcym S.r.l</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Corcym S.r.l</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The objective of the study is to evaluate the safety information on the Perceval S sutureless&#xD;
        prosthetic heart valve after the implantation for aortic valve disease.&#xD;
  &#xD;
        The study is designed as a post-market, observational, non-interventional retrospective and&#xD;
        prospective registry.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In order to monitor the ongoing safety of the Perceval S as part of regulatory requirements,&#xD;
        the study aims to retrospectively collect safety outcomes and performance data in patients&#xD;
        with aortic valve disease implanted with Perceval S since 2022. The data will be used for&#xD;
        regulatory purposes, to support the re-certification of the valve in the Chinese market.&#xD;
  &#xD;
        Serious Adverse Events (SAEs) such as valve-related death, structural valve deterioration,&#xD;
        cerebral thromboembolism, stroke, Transient Ischemic Attack, non-cerebral thromboembolism,&#xD;
        major bleeding, re-operation will be studied to describe the safety profile of the valve.&#xD;
  &#xD;
        Hemodynamic data from site reported echocardiography finding (mean gradient, peak gradient,&#xD;
        effective orifice area, effective orifice area indexed, incidence and degree of PVL and&#xD;
        central leak) at hospital discharge will also be evaluated. Data of approximately 80 subjects&#xD;
        will be collected in four clinical sites in China.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 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>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Mortality</measure>
      <time_frame>up to 1 year</time_frame>
      <description>The number and percentage of subjects died</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Structural valve deterioration</measure>
      <time_frame>up to 1 year</time_frame>
      <description>The number and percentage of subjects with Structural valve deterioration</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cerebral thromboembolism</measure>
      <time_frame>up to 1 year</time_frame>
      <description>The number and percentage of subjects with Cerebral thromboembolism</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Stroke</measure>
      <time_frame>up to 1 year</time_frame>
      <description>The number and percentage of subjects with stroke</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Transient Ischemic Attack (TIA)</measure>
      <time_frame>up to 1 year</time_frame>
      <description>The number and percentage of subjects with Transient Ischemic Attack (TIA)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Non-cerebral thromboembolism</measure>
      <time_frame>up to 1 year</time_frame>
      <description>The number and percentage of subjects with non-cerebral thromboembolism</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Major bleeding</measure>
      <time_frame>up to 1 year</time_frame>
      <description>The number and percentage of subjects with major bleeding</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Re-operation</measure>
      <time_frame>up to 1 year</time_frame>
      <description>The number and percentage of subjects with re-operation</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Aortic Mean Pressure Gradient (MPG)</measure>
      <time_frame>at discharge or 7 days post-procedure (whichever comes first)</time_frame>
      <description>Decrease of MPG from baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Aortic Peak Pressure Gradient (PPG)</measure>
      <time_frame>at discharge or 7 days post-procedure (whichever comes first)</time_frame>
      <description>Decrease of PPG from baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effective Orifice Area (EOA)</measure>
      <time_frame>at discharge or 7 days post-procedure (whichever comes first)</time_frame>
      <description>Increase of EOA from baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effective Orifice Area Index (EOAi)</measure>
      <time_frame>at discharge or 7 days post-procedure (whichever comes first)</time_frame>
      <description>Increase of EOAi from baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Aortic Regurgitation</measure>
      <time_frame>at discharge or 7 days post-procedure (whichever comes first),</time_frame>
      <description>incidence and degree of paravalvular and central leak</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Aortic Valve Disease</condition>
    <arm_group>
      <arm_group_label>Subject implanted with Perceval S sutureless prosthetic heart valve</arm_group_label>
      <description>Subjects who have been implanted with Perceval S sutureless prosthetic heart valve from 2022 onward and subjects that will be implanted up to study closure.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Perceval S sutureless heart valve</intervention_name>
      <description>Aortic Valve Replacement with Perceval S sutureless heart valve</description>
      <arm_group_label>Subject implanted with Perceval S sutureless prosthetic heart valve</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Subjects who have been implanted with Perceval S sutureless prosthetic heart valve from&#xD;
          2022 onward and subjects that will be implanted up to study closure.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subject who has been implanted with Perceval S sutureless aortic heart valve&#xD;
  &#xD;
            2. Subject (legal representative or family member) who has signed the approved informed&#xD;
               consent or would provide verbal informed consent/ signed and dated informed consent,&#xD;
               and available medical information&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          1. Subject (legal representative or family member) who do not provide consent to the data&#xD;
          collection&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mara Chiaro</last_name>
      <role>Study Director</role>
      <affiliation>Corcym S.r.l</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jamie Zhang</last_name>
      <phone>+86 138 1025 8871</phone>
      <email>jamie.zhang@corcym.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Elisa Cerutti</last_name>
      <phone>+393459182413</phone>
      <email>elisa.cerutti@corcym.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 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 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/NCT06011148
  org study id: CCH803
  nct id: NCT06011148
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The objective of the study is to evaluate the safety information on the Perceval S sutureless
        prosthetic heart valve after the implantation for aortic valve disease.
  
        The study is designed as a post-market, observational, non-interventional retrospective and
        prospective registry.
  In order to monitor the ongoing safety of the Perceval S as part of regulatory requirements,
        the study aims to retrospectively collect safety outcomes and performance data in patients
        with aortic valve disease implanted with Perceval S since 2022. The data will be used for
        regulatory purposes, to support the re-certification of the valve in the Chinese market.
  
        Serious Adverse Events (SAEs) such as valve-related death, structural valve deterioration,
        cerebral thromboembolism, stroke, Transient Ischemic Attack, non-cerebral thromboembolism,
        major bleeding, re-operation will be studied to describe the safety profile of the valve.
  
        Hemodynamic data from site reported echocardiography finding (mean gradient, peak gradient,
        effective orifice area, effective orifice area indexed, incidence and degree of PVL and
        central leak) at hospital discharge will also be evaluated. Data of approximately 80 subjects
        will be collected in four clinical sites in China.
  observational model: Cohort
  time perspective: Other
  measure: Mortality
  time frame: up to 1 year
  description: The number and percentage of subjects died
  measure: Structural valve deterioration
  time frame: up to 1 year
  description: The number and percentage of subjects with Structural valve deterioration
  measure: Cerebral thromboembolism
  time frame: up to 1 year
  description: The number and percentage of subjects with Cerebral thromboembolism
  measure: Stroke
  time frame: up to 1 year
  description: The number and percentage of subjects with stroke
  measure: Transient Ischemic Attack (TIA)
  time frame: up to 1 year
  description: The number and percentage of subjects with Transient Ischemic Attack (TIA)
  measure: Non-cerebral thromboembolism
  time frame: up to 1 year
  description: The number and percentage of subjects with non-cerebral thromboembolism
  measure: Major bleeding
  time frame: up to 1 year
  description: The number and percentage of subjects with major bleeding
  measure: Re-operation
  time frame: up to 1 year
  description: The number and percentage of subjects with re-operation
  measure: Aortic Mean Pressure Gradient (MPG)
  time frame: at discharge or 7 days post-procedure (whichever comes first)
  description: Decrease of MPG from baseline
  measure: Aortic Peak Pressure Gradient (PPG)
  time frame: at discharge or 7 days post-procedure (whichever comes first)
  description: Decrease of PPG from baseline
  measure: Effective Orifice Area (EOA)
  time frame: at discharge or 7 days post-procedure (whichever comes first)
  description: Increase of EOA from baseline
  measure: Effective Orifice Area Index (EOAi)
  time frame: at discharge or 7 days post-procedure (whichever comes first)
  description: Increase of EOAi from baseline
  measure: Aortic Regurgitation
  time frame: at discharge or 7 days post-procedure (whichever comes first),
  description: incidence and degree of paravalvular and central leak
  arm group label: Subject implanted with Perceval S sutureless prosthetic heart valve
  description: Subjects who have been implanted with Perceval S sutureless prosthetic heart valve from 2022 onward and subjects that will be implanted up to study closure.
  intervention type: Device
  intervention name: Perceval S sutureless heart valve
  description: Aortic Valve Replacement with Perceval S sutureless heart valve
  arm group label: Subject implanted with Perceval S sutureless prosthetic heart valve
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Mara Chiaro
  role: Study Director
  affiliation: Corcym S.r.l
  last name: Jamie Zhang
  phone: +86 138 1025 8871
  email: jamie.zhang@corcym.com
  last name: Elisa Cerutti
  phone: +393459182413
  email: elisa.cerutti@corcym.com
  responsible party type: Sponsor
  mesh term: Aortic Valve Disease