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| Name | Class |
|---|---|
| ICAN Nutrition Education and Research | INDUSTRY |
| Centre Hospitalier Universitaire de la Guadeloupe | OTHER |
| University Hospital Center of Martinique | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with end-stage Heart Failure | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heart transplantation | Procedure | Heart transplantation in patients who have obtained a favourable and motivated opinion from the Multidisciplinary Consultation Meeting (RCP) of the cardiac surgery department of the Hospital Pitié-Salpêtrière |
| Measure | Description | Time Frame |
|---|---|---|
| Short term recovery of Cardiac function | Cardiac index greater than 2.5 L/min/m2 without inotropic support and/or temporary circulatory assistance (ECMO, IMPELLA, BCPIA) measured by thermodilution (SWAN-GANZ catheter) or echocardiography | Within 15 days after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | 15 days, 30 days, 9 months, 6 months and 12 months | |
| Absence of cardiac deaths | Patient who survived or died for a reason other than failure of cardiac function | 15 days, 30 days, 3 months, 6 months and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume LEBRETON, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pitié-Salpêtrière Hospital | Paris | 75013 | France |
Data are available upon reasonable request. The procedures carried out with the French data regulatory authority (CNIL, Commission Nationale de l'Informatique et des Libertés) do not allow for the transmission of the database, nor do the information and consent documents signed by the patients.
Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Researchers who provide a methodologically sound proposal
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| ID | Term |
|---|---|
| D016027 | Heart Transplantation |
| ID | Term |
|---|---|
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |
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| Cardiac function recovery | Cardiac index greater than 2.5 L/min/m2 without inotropic support and/or temporary circulatory assistance (ECMO, IMPELLA, BCPIA) measured by thermodilution (SWAN-GANZ catheter) or echocardiography | 30 days, 3months, 6 months and 12 months |
| Adverse events after transplant |
| 15 days and 12 months |
| Myocardial preservation | Absence of significant edema (pre- and post-preservation graft weight) | during the procedure/surgery |
| D016377 | Organ Transplantation |
| D014180 | Transplantation |