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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Sep 11, 2023

Keywords

ClinConnect Summary

This clinical trial, called PEGASE, is exploring a new method for heart transplantation. It aims to see if using a special device called an ex-vivo perfusion system can help keep a donated heart healthy for a longer period, allowing it to work well after being transplanted. The goal is for the heart to show good recovery of function within 15 days after the transplant.

To participate in this trial, patients must be over 18 years old and suffering from severe heart failure. They should have a medical need for a heart transplant but might not be able to receive one due to certain policies or personal circumstances. It's important that candidates can provide written consent and understand the process. However, some individuals may not qualify, such as those with other serious health issues or those who are pregnant. This trial is currently not recruiting participants, but it represents an important step in improving heart transplant outcomes for patients in need.

Gender

ALL

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