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/NCT06035991</url>
    </required_header>
    <id_info>
      <org_study_id>APHP220091</org_study_id>
      <nct_id>NCT06035991</nct_id>
    </id_info>
    <brief_title>First Clinical Evaluation of Heart Transplantation With Grafts Preserved Using an Ex-vivo Extended Perfusion System</brief_title>
    <acronym>PEGASE</acronym>
    <official_title>Première Evaluation Clinique de la Transplantation Cardiaque de Greffons préservés à l'Aide d'un Système de Perfusion Ex-vivo prolongée</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assistance Publique - Hôpitaux de Paris</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>ICAN Nutrition Education and Research</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>Centre Hospitalier Universitaire de Pointe-a-Pitre</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University Hospital Center of Martinique</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Assistance Publique - Hôpitaux de Paris</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>
        The main objective of PEGASE is to validate the recovery of a satisfactory cardiac function&#xD;
        of a transplanted heart after a prolonged period of preservation by an ex-vivo perfusion&#xD;
        device. This recovery of cardiac function will have to happen within 15 days after&#xD;
        transplantation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Heart transplantation is a scarce resource, only 1 patient among 2 had the opportunity to be&#xD;
        grafted in France in 2022. Despite the shortage of organs, some potential heart transplants&#xD;
        are currently not recovered because the ischemia duration anticipated before being grafted&#xD;
        (from donor to recipient) is too long and not compatible with transplantation, actually&#xD;
        limited to 4h, max.&#xD;
  &#xD;
        Innovation in ex-vivo hypothermic perfusion allows to consider the extension of the graft&#xD;
        viability time, thus offering the possibility of extending the pool of heart grafts available&#xD;
        to the patients, The study aims to demonstrate the feasibility of taking heart grafts from&#xD;
        donors in Martinique and Guadeloupe, transferring them via air transport and then&#xD;
        successfully transplanting them to patients hospitalized in France, up to 14 hours later,&#xD;
        using an ex-vivo cold perfusion device to protect the heart during transport.&#xD;
  &#xD;
        Patients involved in this study will be patients in desperate need of transplantation, with&#xD;
        no chance of receiving it, due to the French transplant allocation policy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2028</completion_date>
    <primary_completion_date type="Anticipated">September 2025</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>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Short term recovery of Cardiac function</measure>
      <time_frame>Within 15 days after transplantation</time_frame>
      <description>Cardiac index greater than 2.5 L/min/m2 without inotropic support and/or temporary circulatory assistance (ECMO, IMPELLA, BCPIA) measured by thermodilution (SWAN-GANZ catheter) or echocardiography</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Survival</measure>
      <time_frame>15 days, 30 days, 9 months, 6 months and 12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Absence of cardiac deaths</measure>
      <time_frame>15 days, 30 days, 3 months, 6 months and 12 months</time_frame>
      <description>Patient who survived or died for a reason other than failure of cardiac function</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiac function recovery</measure>
      <time_frame>30 days, 3months, 6 months and 12 months</time_frame>
      <description>Cardiac index greater than 2.5 L/min/m2 without inotropic support and/or temporary circulatory assistance (ECMO, IMPELLA, BCPIA) measured by thermodilution (SWAN-GANZ catheter) or echocardiography</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events after transplant</measure>
      <time_frame>15 days and 12 months</time_frame>
      <description>moderate or severe primary graft dysfunction (according to ISHLT consensus),&#xD;
  acute cell rejection &gt;2R, VAD &gt;1,&#xD;
  long-term circulatory support (LVAD, BiVAD, TAH)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Myocardial preservation</measure>
      <time_frame>during the procedure/surgery</time_frame>
      <description>Absence of significant edema (pre- and post-preservation graft weight)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Heart Transplantation</condition>
    <arm_group>
      <arm_group_label>Patients with end-stage Heart Failure</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Heart transplantation</intervention_name>
      <description>Heart transplantation in patients who have obtained a favourable and motivated opinion from the Multidisciplinary Consultation Meeting (RCP) of the cardiac surgery department of the Hospital Pitié-Salpêtrière</description>
      <arm_group_label>Patients with end-stage Heart Failure</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients over 18 years of age&#xD;
  &#xD;
            -  Patients suffering from irreversible terminal heart failure with a medical indication&#xD;
               for heart transplantation but who cannot be transplanted (per the graft allocation&#xD;
               policy in France) or assisted (technical impossibility, contraindication, patient's&#xD;
               refusal) and for whom a favourable and motivated opinion from the Multidisciplinary&#xD;
               Consultation Meeting (RCP) of the cardiac surgery department of the Hospital&#xD;
               Pitié-Salpêtrière has been made&#xD;
  &#xD;
            -  Having given their informed consent in writing&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Technical obstacles which would generate an excessive surgical risk for the patient&#xD;
               according to the medical opinion such as comorbidities or associated pathology not&#xD;
               compatible with a transplant&#xD;
  &#xD;
            -  Known ongoing sepsis, defined as positive blood culture immediately prior to&#xD;
               transplant (including with ventricular assist device)&#xD;
  &#xD;
            -  Candidate patient for Combined Organ Transplantation&#xD;
  &#xD;
            -  Patient protected by law (guardianship, curatorship, deprived of liberty)&#xD;
  &#xD;
            -  No affiliated with or entitled to a French social security scheme (AME included)&#xD;
  &#xD;
            -  Pregnant or breast-feeding female&#xD;
  &#xD;
            -  Current participation in another interventional study (category 1 of French Jardé law)&#xD;
               or being in the exclusion period at the end of a previous study&#xD;
  &#xD;
            -  Patient unable to understand the information provided during the informed consent&#xD;
               procedure&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Guillaume LEBRETON, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Guillaume LEBRETON, MD, PhD</last_name>
      <phone>0142162979</phone>
      <phone_ext>+33</phone_ext>
      <email>guillaume.lebreton@aphp.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Pascal LEPRINCE, MD, PhD</last_name>
      <phone>0142165632</phone>
      <phone_ext>+33</phone_ext>
      <email>pascal.leprince@aphp.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Pitié-Salpêtrière Hospital</name>
        <address>
          <city>Paris</city>
          <zip>75013</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Guillaume LEBRETON, MD, PhD</last_name>
        <phone>0142162979</phone>
        <phone_ext>+33</phone_ext>
        <email>guillaume.lebreton@aphp.fr</email>
      </contact>
      <contact_backup>
        <last_name>Zohra ABBOU</last_name>
        <phone>0142161625</phone>
        <phone_ext>+33</phone_ext>
        <email>zohra.abbou@aphp.fr</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 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 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Heart transplantation</keyword>
    <keyword>XVIVO perfusion</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Data are available upon reasonable request. The procedures carried out with the French data regulatory authority (CNIL, Commission Nationale de l'Informatique et des Libertés) do not allow for the transmission of the database, nor do the information and consent documents signed by the patients.&#xD;
  Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor</ipd_time_frame>
      <ipd_access_criteria>Researchers who provide a methodologically sound proposal</ipd_access_criteria>
    </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/NCT06035991
  org study id: APHP220091
  nct id: NCT06035991
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The main objective of PEGASE is to validate the recovery of a satisfactory cardiac function
        of a transplanted heart after a prolonged period of preservation by an ex-vivo perfusion
        device. This recovery of cardiac function will have to happen within 15 days after
        transplantation.
  Heart transplantation is a scarce resource, only 1 patient among 2 had the opportunity to be
        grafted in France in 2022. Despite the shortage of organs, some potential heart transplants
        are currently not recovered because the ischemia duration anticipated before being grafted
        (from donor to recipient) is too long and not compatible with transplantation, actually
        limited to 4h, max.
  
        Innovation in ex-vivo hypothermic perfusion allows to consider the extension of the graft
        viability time, thus offering the possibility of extending the pool of heart grafts available
        to the patients, The study aims to demonstrate the feasibility of taking heart grafts from
        donors in Martinique and Guadeloupe, transferring them via air transport and then
        successfully transplanting them to patients hospitalized in France, up to 14 hours later,
        using an ex-vivo cold perfusion device to protect the heart during transport.
  
        Patients involved in this study will be patients in desperate need of transplantation, with
        no chance of receiving it, due to the French transplant allocation policy.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Short term recovery of Cardiac function
  time frame: Within 15 days after transplantation
  description: Cardiac index greater than 2.5 L/min/m2 without inotropic support and/or temporary circulatory assistance (ECMO, IMPELLA, BCPIA) measured by thermodilution (SWAN-GANZ catheter) or echocardiography
  measure: Survival
  time frame: 15 days, 30 days, 9 months, 6 months and 12 months
  measure: Absence of cardiac deaths
  time frame: 15 days, 30 days, 3 months, 6 months and 12 months
  description: Patient who survived or died for a reason other than failure of cardiac function
  measure: Cardiac function recovery
  time frame: 30 days, 3months, 6 months and 12 months
  description: Cardiac index greater than 2.5 L/min/m2 without inotropic support and/or temporary circulatory assistance (ECMO, IMPELLA, BCPIA) measured by thermodilution (SWAN-GANZ catheter) or echocardiography
  measure: Adverse events after transplant
  time frame: 15 days and 12 months
  description: moderate or severe primary graft dysfunction (according to ISHLT consensus),
  acute cell rejection >2R, VAD >1,
  long-term circulatory support (LVAD, BiVAD, TAH)
  measure: Myocardial preservation
  time frame: during the procedure/surgery
  description: Absence of significant edema (pre- and post-preservation graft weight)
  arm group label: Patients with end-stage Heart Failure
  arm group type: Experimental
  intervention type: Procedure
  intervention name: Heart transplantation
  description: Heart transplantation in patients who have obtained a favourable and motivated opinion from the Multidisciplinary Consultation Meeting (RCP) of the cardiac surgery department of the Hospital Pitié-Salpêtrière
  arm group label: Patients with end-stage Heart Failure
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Guillaume LEBRETON, MD, PhD
  role: Principal Investigator
  affiliation: Assistance Publique - Hôpitaux de Paris
  last name: Guillaume LEBRETON, MD, PhD
  phone: 0142162979
  phone ext: +33
  email: guillaume.lebreton@aphp.fr
  last name: Pascal LEPRINCE, MD, PhD
  phone: 0142165632
  phone ext: +33
  email: pascal.leprince@aphp.fr
  facility: 
  contact: 
  contact backup: 
  country: France
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: Data are available upon reasonable request. The procedures carried out with the French data regulatory authority (CNIL, Commission Nationale de l'Informatique et des Libertés) do not allow for the transmission of the database, nor do the information and consent documents signed by the patients.
  Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
  ipd access criteria: Researchers who provide a methodologically sound proposal