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/NCT05986396</url>
    </required_header>
    <id_info>
      <org_study_id>H-51357</org_study_id>
      <nct_id>NCT05986396</nct_id>
    </id_info>
    <brief_title>Outcomes of Pulmonary Valve Replacement With the INSPIRIS (Model 11500A) Valve</brief_title>
    <official_title>Outcomes of Pulmonary Valve Replacement With the INSPIRIS (Model 11500A) Valve for Pulmonary Valve Replacement in Children and Young Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Baylor College of Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Edwards Lifesciences</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Baylor College of Medicine</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this retrospective chart review is to contribute to the literature on the&#xD;
        mid-term durability and hemodynamics of the INSPIRS Resilia bioprosthesis when implanted in&#xD;
        children and young adults.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The primary objective of our study is to contribute to the scarce body of literature on the&#xD;
        mid-term durability and hemodynamics of the INSPIRIS Resilia (model 11500) bioprosthesis when&#xD;
        implanted in the pulmonary position in children and young adults. Investigators also aim to&#xD;
        identify: effect of age on SVD, freedom from SVD, pathology of SVD, valve-related&#xD;
        complications, freedom from re-operation, and survival rate.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 3, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Contribute to the scarce body of literature</measure>
      <time_frame>5 years after implantation</time_frame>
      <description>The primary objective of our study is to contribute to the scarce body of literature on the mid-term durability and hemodynamics of the INSPIRIS Resilia (model 11500) bioprosthesis when implanted in the pulmonary position in children and young adults</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Identify the effect of age of the INSPIRIS Resilia (model 11500) bioprosthesis when implanted in the pulmonary position in children and young adults</measure>
      <time_frame>5 years after implantation</time_frame>
      <description>Structural valve deterioration, freedom from SVD, valve related complications, freedom from re-operation, survival rate</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Heart Valve Prosthesis</condition>
    <arm_group>
      <arm_group_label>All Subjects</arm_group_label>
      <description>Subjects that have received the INSPIRIS Resilia device.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>INSPIRIS Resilia (model 11500A)</intervention_name>
      <description>Aortic Valve</description>
      <arm_group_label>All Subjects</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Subjects with congenital heart disease that have received the INSPIRIS Resilia device.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Subjects that have received the INSPIRIS Resilia device at participating institutions from&#xD;
          06/2017 through 12/2022.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Subjects that have not received the INSPIRIS Resilia device.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>0 Years</minimum_age>
      <maximum_age>64 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Victor Bautista-Hernandez, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Baylor College of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Rosario Ocampo, BSN</last_name>
      <phone>210-704-4996</phone>
      <email>rosario.ocampo@christushealth.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Baylor College of Medicine at CHRISTUS Children's</name>
        <address>
          <city>San Antonio</city>
          <state>Texas</state>
          <zip>78207</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rosario Ocampo, BSN</last_name>
        <phone>210-704-4996</phone>
        <email>rosario.ocampo@christushealth.org</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
      <investigator_full_name>Victor Bautista Hernandez</investigator_full_name>
      <investigator_title>Associate Professor of Surgery</investigator_title>
    </responsible_party>
    <keyword>Pulmonary Valve Replacement</keyword>
    <keyword>Pulmonary Valve</keyword>
    <keyword>Congenital Heart Disease</keyword>
    <keyword>INSPIRIS Resilia</keyword>
    <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/NCT05986396
  org study id: H-51357
  nct id: NCT05986396
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this retrospective chart review is to contribute to the literature on the
        mid-term durability and hemodynamics of the INSPIRS Resilia bioprosthesis when implanted in
        children and young adults.
  The primary objective of our study is to contribute to the scarce body of literature on the
        mid-term durability and hemodynamics of the INSPIRIS Resilia (model 11500) bioprosthesis when
        implanted in the pulmonary position in children and young adults. Investigators also aim to
        identify: effect of age on SVD, freedom from SVD, pathology of SVD, valve-related
        complications, freedom from re-operation, and survival rate.
  observational model: Other
  time perspective: Retrospective
  measure: Contribute to the scarce body of literature
  time frame: 5 years after implantation
  description: The primary objective of our study is to contribute to the scarce body of literature on the mid-term durability and hemodynamics of the INSPIRIS Resilia (model 11500) bioprosthesis when implanted in the pulmonary position in children and young adults
  measure: Identify the effect of age of the INSPIRIS Resilia (model 11500) bioprosthesis when implanted in the pulmonary position in children and young adults
  time frame: 5 years after implantation
  description: Structural valve deterioration, freedom from SVD, valve related complications, freedom from re-operation, survival rate
  arm group label: All Subjects
  description: Subjects that have received the INSPIRIS Resilia device.
  intervention type: Device
  intervention name: INSPIRIS Resilia (model 11500A)
  description: Aortic Valve
  arm group label: All Subjects
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 0 Years
  maximum age: 64 Years
  healthy volunteers: No
  last name: Victor Bautista-Hernandez, MD, PhD
  role: Principal Investigator
  affiliation: Baylor College of Medicine
  last name: Rosario Ocampo, BSN
  phone: 210-704-4996
  email: rosario.ocampo@christushealth.org
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Baylor College of Medicine
  investigator full name: Victor Bautista Hernandez
  investigator title: Associate Professor of Surgery
  sharing ipd: No