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First Clinical Evaluation of Heart Transplantation With Grafts Preserved Using an Ex-vivo Extended Perfusion System (PEGASE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06035991
Recruitment Status : Not yet recruiting
First Posted : September 13, 2023
Last Update Posted : September 13, 2023
Sponsor:
Collaborators:
ICAN Nutrition Education and Research
Centre Hospitalier Universitaire de Pointe-a-Pitre
University Hospital Center of Martinique
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Transplantation Procedure: Heart transplantation Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Première Evaluation Clinique de la Transplantation Cardiaque de Greffons préservés à l'Aide d'un Système de Perfusion Ex-vivo prolongée
Estimated Study Start Date : September 2023
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Patients with end-stage Heart Failure Procedure: Heart transplantation
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


Outcome Measures
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Primary Outcome Measures :
  1. Short term recovery of Cardiac function [ Time Frame: Within 15 days after transplantation ]
    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


Secondary Outcome Measures :
  1. Survival [ Time Frame: 15 days, 30 days, 9 months, 6 months and 12 months ]
  2. Absence of cardiac deaths [ Time Frame: 15 days, 30 days, 3 months, 6 months and 12 months ]
    Patient who survived or died for a reason other than failure of cardiac function

  3. Cardiac function recovery [ Time Frame: 30 days, 3months, 6 months and 12 months ]
    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

  4. Adverse events after transplant [ Time Frame: 15 days and 12 months ]
    • moderate or severe primary graft dysfunction (according to ISHLT consensus),
    • acute cell rejection >2R, VAD >1,
    • long-term circulatory support (LVAD, BiVAD, TAH)

  5. Myocardial preservation [ Time Frame: during the procedure/surgery ]
    Absence of significant edema (pre- and post-preservation graft weight)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients over 18 years of age
  • Patients suffering from irreversible terminal heart failure with a medical indication for heart transplantation but who cannot be transplanted (per the graft allocation policy in France) or assisted (technical impossibility, contraindication, patient's refusal) and for whom a favourable and motivated opinion from the Multidisciplinary Consultation Meeting (RCP) of the cardiac surgery department of the Hospital Pitié-Salpêtrière has been made
  • Having given their informed consent in writing

Exclusion Criteria:

  • Technical obstacles which would generate an excessive surgical risk for the patient according to the medical opinion such as comorbidities or associated pathology not compatible with a transplant
  • Known ongoing sepsis, defined as positive blood culture immediately prior to transplant (including with ventricular assist device)
  • Candidate patient for Combined Organ Transplantation
  • Patient protected by law (guardianship, curatorship, deprived of liberty)
  • No affiliated with or entitled to a French social security scheme (AME included)
  • Pregnant or breast-feeding female
  • Current participation in another interventional study (category 1 of French Jardé law) or being in the exclusion period at the end of a previous study
  • Patient unable to understand the information provided during the informed consent procedure
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06035991


Contacts
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Contact: Guillaume LEBRETON, MD, PhD 0142162979 ext +33 guillaume.lebreton@aphp.fr
Contact: Pascal LEPRINCE, MD, PhD 0142165632 ext +33 pascal.leprince@aphp.fr

Locations
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France
Pitié-Salpêtrière Hospital
Paris, France, 75013
Contact: Guillaume LEBRETON, MD, PhD    0142162979 ext +33    guillaume.lebreton@aphp.fr   
Contact: Zohra ABBOU    0142161625 ext +33    zohra.abbou@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
ICAN Nutrition Education and Research
Centre Hospitalier Universitaire de Pointe-a-Pitre
University Hospital Center of Martinique
Investigators
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Principal Investigator: Guillaume LEBRETON, MD, PhD Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT06035991    
Other Study ID Numbers: APHP220091
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: September 13, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
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
Access Criteria: Researchers who provide a methodologically sound proposal

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Heart transplantation
XVIVO perfusion