Clinical trial NCT06035991: First Clinical Evaluation of Heart Transplantation With Grafts Preserved Using an Ex-vivo Extended Perfusion System
Official title: Première Evaluation Clinique de la Transplantation Cardiaque de Greffons préservés à l'Aide d'un Système de Perfusion Ex-vivo prolongée
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Transplantation
Keywords: Heart transplantation
XVIVO perfusion
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: ICAN Nutrition Education and Research
name: Centre Hospitalier Universitaire de la Guadeloupe
name: University Hospital Center of Martinique
First posted: 2023-09-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Short term recovery of Cardiac function
timeFrame: Within 15 days after transplantation
Secondary outcomes:
measure: Survival
timeFrame: 15 days, 30 days, 9 months, 6 months and 12 months
measure: Absence of cardiac deaths
timeFrame: 15 days, 30 days, 3 months, 6 months and 12 months
measure: Cardiac function recovery
timeFrame: 30 days, 3months, 6 months and 12 months
measure: Adverse events after transplant
timeFrame: 15 days and 12 months
measure: Myocardial preservation
timeFrame: during the procedure/surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Pitié-Salpêtrière Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Guillaume LEBRETON, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: