Status:
NOT_YET_RECRUITING
First Clinical Evaluation of Heart Transplantation With Grafts Preserved Using an Ex-vivo Extended Perfusion System
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
ICAN Nutrition Education and Research
Centre Hospitalier Universitaire de la Guadeloupe
Conditions:
Heart Transplantation
Eligibility:
All Genders
18-100 years
Phase:
NA
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 recove...
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 n...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06035991
Start Date
September 1 2023
End Date
September 1 2028
Last Update
September 13 2023
Active Locations (1)
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1
Pitié-Salpêtrière Hospital
Paris, France, 75013