<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/NCT03022708</url>
  </required_header>
  <id_info>
    <org_study_id>XEL-CR-03</org_study_id>
    <nct_id>NCT03022708</nct_id>
  </id_info>
  <brief_title>Xeltis Bioabsorbable Pulmonary Valved Conduit Pivotal Study</brief_title>
  <acronym>Xplore2</acronym>
  <official_title>Prospective, Non-randomized, Pivotal Study to Assess the Safety and Efficacy of the Bioabsorbable Pulmonary Valved Conduit in Subjects Undergoing Right Ventricular Outflow Tract (RVOT) Reconstruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xeltis</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xeltis</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multi-center prospective, single-arm, non-randomized, pivotal study that will&#xD;
      continue to access the feasibility of the Xeltis Bioabsorbable Pulmonary Valved Conduit in&#xD;
      subjects requiring right ventricular outflow tract correction or reconstruction due to&#xD;
      congenital heart malformations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">May 8, 2017</start_date>
  <completion_date type="Anticipated">December 2026</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite rate of events of device related death, re-operation or re-intervention at 12 months follow-up.</measure>
    <time_frame>12 months</time_frame>
    <description>Measured once all 12 month follow up visits have been completed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall rate of device related death due to device failure at 6 months follow up post implantation.</measure>
    <time_frame>6 months</time_frame>
    <description>Measured once all 6 month follow up visits have been completed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall rate of mortality at 60 months follow up post implantation.</measure>
    <time_frame>60 months</time_frame>
    <description>Measured once all 60 months follow up visits have been completed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall rate of subjects who require reoperation or re-intervention due to device failure 12 months.</measure>
    <time_frame>12 months</time_frame>
    <description>Measured once all 12 month follow upvisits have been completed .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall rate of subjects with a mean pressure gradient across the area of conduit implantation of less than 40 mm Hg at 6 and 12 months follow up.</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Measured by echography at 6 and 12 months follow up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall rate of subjects with pulmonary regurgitation of equal or less than moderate at 6 and 12 months follow up.</measure>
    <time_frame>6 and 12 months</time_frame>
    <description>Measured by echography at 6 and 12 months follow up.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Measurement of growth of conduit in pediatric population measured at 6, 36, 48 and 60 months. A competent valve with increased valve diameter in age groups &lt; 18 years in correlation with the increased body surface area.</measure>
    <time_frame>Up to 60 months</time_frame>
    <description>Measured with echocardiography at 6, 36, 48 and 60 months follow up.</description>
  </other_outcome>
  <other_outcome>
    <measure>Overall satisfaction of the implanting surgeon of the implantation procedure of the Bio-absorbable pulmonary valve conduit</measure>
    <time_frame>Day 0 - Implant</time_frame>
    <description>Measured with a questionnaire given to the implanting surgeon at the time of implantation of the pulmonary valve conduit.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">56</enrollment>
  <condition>Heart Defect, Congenital</condition>
  <arm_group>
    <arm_group_label>Xeltis Bioabsorbable Pulmonary Valved Conduit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Bioabsorbable Pulmonary Valved Conduit bio-absorbable, polymer-based medical device.&#xD;
The PV conduit is used in patients for correction or reconstruction of the Right Ventricular Outflow Tract (RVOT), in patients less than 22 years with any of the following congenital heart malformations:&#xD;
Tetralogy of Fallot&#xD;
Truncus Arteriosus&#xD;
Pulmonary Atresia&#xD;
Transposition of Great Arteries with Ventricular Septal Defect&#xD;
Pulmonary Stenosis in combination with other defects in congenital heart defect (CHD) syndromes&#xD;
In addition, the PV conduit can be used for the following indications:&#xD;
replacement of previously implanted, but dysfunctional, pulmonary homografts or valved conduits (except for mechanical valves, see exclusion criterion 3).&#xD;
Patients undergoing a Ross procedure, where the PV conduit would replace the patient's own pulmonary valve which is used to replace a diseased aortic valve.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Xeltis Bioabsorbable Pulmonary Valved Conduit</intervention_name>
    <description>Surgical implantation of Xeltis Bioabsorbable Pulmonary Valved Conduit</description>
    <arm_group_label>Xeltis Bioabsorbable Pulmonary Valved Conduit</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient requiring RVOT reconstruction, suitable for 16 mm,18 mm, 20 mm and 22 mm&#xD;
             valved conduit.&#xD;
&#xD;
          2. Male or Female.&#xD;
&#xD;
          3. Age &gt; 2 years and &lt; 22 years.&#xD;
&#xD;
          4. Right Ventricular to Pulmonary Artery peak gradient &gt; 35mm Hg or moderate or severe&#xD;
             Pulmonary regurgitation (≥3+), or have both (except for the patients undergoing a Ross&#xD;
             procedure)&#xD;
&#xD;
          5. The patient, and the patient's parent / legal representative where appropriate, has&#xD;
             been informed of the nature of the study, agrees to its provisions and has provided&#xD;
             written informed consent by signing the approved informed consent form.&#xD;
&#xD;
          6. The patient, and the patient's parent / legal representative where appropriate, and&#xD;
             the treating physician agree that the subject will return for all required&#xD;
             post-procedure follow up visits and the subject will comply with clinical&#xD;
             investigation plan required follow-up visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Need for or presence of prosthetic heart valve at other position.&#xD;
&#xD;
          2. Need for concomitant surgical procedures (non-cardiac).&#xD;
&#xD;
          3. Patients with previously implanted pacemaker (including defibrillators), or mechanical&#xD;
             valves.&#xD;
&#xD;
          4. Active infection or requiring current antibiotic therapy (if temporary illness,&#xD;
             subject may be a candidate 4 weeks after discontinuation of antibiotics) or viral&#xD;
             infection.&#xD;
&#xD;
          5. Active endocarditis.&#xD;
&#xD;
          6. Leukopenia, defined as White Blood cell Count &lt; than:&#xD;
&#xD;
               -  2-12 years: 5.0 ×103 /μL&#xD;
&#xD;
               -  12 years - Adult:&#xD;
&#xD;
               -  Male: 4.5×103 /μL&#xD;
&#xD;
               -  Female: 4.5 ×103 /μL&#xD;
&#xD;
          7. Acute or chronic anemia, defined as Hemoglobin &lt; than:&#xD;
&#xD;
               -  2-12 years 11.5 g /dl&#xD;
&#xD;
               -  12-18:&#xD;
&#xD;
               -  Male: 13 g /dl&#xD;
&#xD;
               -  Female 12 g /dl&#xD;
&#xD;
               -  Adult:&#xD;
&#xD;
               -  Male: 13.5 g /dl&#xD;
&#xD;
               -  Female: 12 g /dl Patients can be transfused to meet eligibility criteria&#xD;
&#xD;
          8. Thrombocytopenia, defined as Platelet count &lt; than:&#xD;
&#xD;
               -  150,000/mm3 Patients can be transfused to meet eligibility criteria&#xD;
&#xD;
          9. Severe chest wall deformity, which would preclude placement of the PV conduit.&#xD;
&#xD;
         10. Pulmonary hypertension (≥ half of systemic systolic pressure)&#xD;
&#xD;
         11. Right ventricular outflow tract aneurysm.&#xD;
&#xD;
         12. Known hypersensitivity to anticoagulants and antiplatelet drugs and to the device&#xD;
             materials. .&#xD;
&#xD;
         13. Immunocompromised patient defined as: autoimmune disease, patients receiving&#xD;
             immunosuppressant drugs or immune stimulant drugs.&#xD;
&#xD;
         14. Subject has chronic inflammatory / autoimmune disease.&#xD;
&#xD;
         15. Need for emergency cardiac or vascular surgery or intervention.&#xD;
&#xD;
         16. Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that&#xD;
             has a life expectancy of less than one year.&#xD;
&#xD;
         17. Currently participating, or participated within the last 30 days, in an&#xD;
             investigational drug or device study.&#xD;
&#xD;
         18. Alcohol or drug abuse as defined by DSM IV-TR criteria for substance abuse - this&#xD;
             includes the illicit use of cannabis within the last 12 months.&#xD;
&#xD;
         19. Pregnancy.&#xD;
&#xD;
         20. Females who are sexually active and are not willing to use adequate contraceptive&#xD;
             precautions for the next 2 years&#xD;
&#xD;
         21. Subject has medical, social or psychosocial factors that, in the opinion of the&#xD;
             Investigator, could impact safety or compliance.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eliane Schutte</last_name>
    <role>Study Director</role>
    <affiliation>Xeltis Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital of Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Joe DiMaggio Children's Hospital</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Presbyterian Hospital - Columbia University (Xplore1)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Pittsburgh of UPMC (Xplore1)</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UTSW- Dallas Children's Hospital</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390-8835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multiprofile Hospital for Active Treatment &quot;National cardiology hospital&quot; EAD, Department of Congenital Heart Defects Surgery</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Jantung Negara Sdn Bhd</name>
      <address>
        <city>Kuala Lumpur</city>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Children's Hospital of Cracow</name>
      <address>
        <city>Kraków</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Malaysia</country>
    <country>Poland</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>January 24, 2023</last_update_submitted>
  <last_update_submitted_qc>January 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 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>Heart Defects, Congenital</mesh_term>
    <mesh_term>Congenital Abnormalities</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03022708
org study id: XEL-CR-03
nct id: NCT03022708
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
This is a multi-center prospective, single-arm, non-randomized, pivotal study that will
      continue to access the feasibility of the Xeltis Bioabsorbable Pulmonary Valved Conduit in
      subjects requiring right ventricular outflow tract correction or reconstruction due to
      congenital heart malformations.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Composite rate of events of device related death, re-operation or re-intervention at 12 months follow-up.
time frame: 12 months
description: Measured once all 12 month follow up visits have been completed
measure: Overall rate of device related death due to device failure at 6 months follow up post implantation.
time frame: 6 months
description: Measured once all 6 month follow up visits have been completed
measure: Overall rate of mortality at 60 months follow up post implantation.
time frame: 60 months
description: Measured once all 60 months follow up visits have been completed
measure: Overall rate of subjects who require reoperation or re-intervention due to device failure 12 months.
time frame: 12 months
description: Measured once all 12 month follow upvisits have been completed .
measure: Overall rate of subjects with a mean pressure gradient across the area of conduit implantation of less than 40 mm Hg at 6 and 12 months follow up.
time frame: 6 and 12 months
description: Measured by echography at 6 and 12 months follow up.
measure: Overall rate of subjects with pulmonary regurgitation of equal or less than moderate at 6 and 12 months follow up.
time frame: 6 and 12 months
description: Measured by echography at 6 and 12 months follow up.
measure: Measurement of growth of conduit in pediatric population measured at 6, 36, 48 and 60 months. A competent valve with increased valve diameter in age groups < 18 years in correlation with the increased body surface area.
time frame: Up to 60 months
description: Measured with echocardiography at 6, 36, 48 and 60 months follow up.
measure: Overall satisfaction of the implanting surgeon of the implantation procedure of the Bio-absorbable pulmonary valve conduit
time frame: Day 0 - Implant
description: Measured with a questionnaire given to the implanting surgeon at the time of implantation of the pulmonary valve conduit.
arm group label: Xeltis Bioabsorbable Pulmonary Valved Conduit
arm group type: Experimental
description: The Bioabsorbable Pulmonary Valved Conduit bio-absorbable, polymer-based medical device.
The PV conduit is used in patients for correction or reconstruction of the Right Ventricular Outflow Tract (RVOT), in patients less than 22 years with any of the following congenital heart malformations:
Tetralogy of Fallot
Truncus Arteriosus
Pulmonary Atresia
Transposition of Great Arteries with Ventricular Septal Defect
Pulmonary Stenosis in combination with other defects in congenital heart defect (CHD) syndromes
In addition, the PV conduit can be used for the following indications:
replacement of previously implanted, but dysfunctional, pulmonary homografts or valved conduits (except for mechanical valves, see exclusion criterion 3).
Patients undergoing a Ross procedure, where the PV conduit would replace the patient's own pulmonary valve which is used to replace a diseased aortic valve.
intervention type: Device
intervention name: Xeltis Bioabsorbable Pulmonary Valved Conduit
description: Surgical implantation of Xeltis Bioabsorbable Pulmonary Valved Conduit
arm group label: Xeltis Bioabsorbable Pulmonary Valved Conduit
criteria: 
gender: All
minimum age: 2 Years
maximum age: 21 Years
healthy volunteers: No
last name: Eliane Schutte
role: Study Director
affiliation: Xeltis Inc
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Bulgaria
country: Malaysia
country: Poland
country: United States
responsible party type: Sponsor
mesh term: Heart Defects, Congenital
mesh term: Congenital Abnormalities
sharing ipd: No