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

Not Applicable

Not yet recruiting

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.

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Patients with end-stage Heart Failure	Heart transplantation	-

Primary Outcome Measures

Name	Time	Method
Short term recovery of Cardiac function	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

Name	Time	Method
Absence of cardiac deaths	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
Survival	15 days, 30 days, 9 months, 6 months and 12 months
Myocardial preservation	during the procedure/surgery	Absence of significant edema (pre- and post-preservation graft weight)
Cardiac function recovery	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
Adverse events after transplant	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)

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