Heart Transplantation Clinical Trial
Official title:
Première Evaluation Clinique de la Transplantation Cardiaque de Greffons préservés à l'Aide d'un Système de Perfusion Ex-vivo prolongée
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT01927614 -
Advanced Cardiac Imaging in Cardiac Allograft Vasculopathy
|
N/A | |
| Recruiting |
NCT01705015 -
Organ Transplantation Rehabilitation: Effect of Bedside Exercise Device and Activity Reinforcement
|
N/A | |
| Completed |
NCT01655563 -
Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation
|
Phase 2 | |
| Completed |
NCT01028599 -
Effect of Physical Training on Oxygen Uptake and Endothelial Function in Heart Transplant Recipients
|
N/A | |
| Completed |
NCT00531921 -
Effects of Donor and Recipient Genetic Expression on Heart, Lung, Liver, or Kidney Transplant Survival
|
N/A | |
| Terminated |
NCT00420537 -
Shift to Everolimus (RAD) Kidney Sparing Study
|
Phase 4 | |
| Enrolling by invitation |
NCT03292861 -
The Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients
|
Phase 2 | |
| Recruiting |
NCT04924491 -
Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Prevent Rejection in Heart Transplant Children
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05270902 -
Haemoadsorption During Heart Transplantation
|
N/A | |
| Active, not recruiting |
NCT05289180 -
Brachial Right Ventricle - Endomyocardial Biopsy
|
||
| Recruiting |
NCT03687723 -
Observational Study of the Clinical Use of the OCS™ Heart
|
||
| Completed |
NCT01091194 -
Effect of Exercise After Heart Transplantation
|
Phase 2 | |
| Terminated |
NCT00678002 -
Quality of Life in Pediatric Transplant Patients
|
||
| Withdrawn |
NCT00780637 -
Brachial Artery t-PA Release in Heart Transplant Recipients
|
N/A | |
| Withdrawn |
NCT00780377 -
Intracoronary Bradykinin Mediated t-PA Release in Heart Transplant Recipients
|
N/A | |
| Completed |
NCT01182571 -
Exploration of Fatigue, Uncertainty, Depression and Quality of Life in Heart Transplantation Recipients
|
N/A | |
| Terminated |
NCT00121784 -
Heart Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Heart Transplant Recipients
|
Phase 4 | |
| Withdrawn |
NCT00572286 -
Non-invasive Evaluation of Heart Transplant Rejection- Pilot Study
|
N/A | |
| Completed |
NCT00690157 -
Registry of Patients Referred for Heart Transplantation
|
N/A | |
| Completed |
NCT00123331 -
Rapamycin Use in Calcineurin Inhibitor (CNI)-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation
|
Phase 4 |