Heart Transplantation
Conditions
Keywords
Heart transplantation, XVIVO perfusion
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.
Interventions
PROCEDUREHeart 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
Sponsors
Assistance Publique - Hôpitaux de Paris
ICAN Nutrition Education and Research
Centre Hospitalier Universitaire de la Guadeloupe
University Hospital Center of Martinique
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Survival | 15 days, 30 days, 9 months, 6 months and 12 months | — |
| 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 |
| 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) |
| Myocardial preservation | during the procedure/surgery | Absence of significant edema (pre- and post-preservation graft weight) |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORGuillaume LEBRETON, MD, PhD
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed