Informations générales (source: ClinicalTrials.gov)
Première Evaluation Clinique de la Transplantation Cardiaque de Greffons préservés à l'Aide d'un Système de Perfusion Ex-vivo prolongée
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
octobre 2023
octobre 2028
02 avril 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP Assistance publique - Hôpitaux de Paris | 27/12/2025 07:43:06 | Contacter | |||
| AP-HP - Hôpital La Pitié-Salpêtrière | |||||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital La Pitié-Salpêtrière | Contact (sur clinicalTrials) | ||||
Critères
Tous
- 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