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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06035991
Other study ID # APHP220091
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2023
Est. completion date September 2028

Study information

Verified date July 2023
Source Assistance Publique - Hôpitaux de Paris
Contact Guillaume LEBRETON, MD, PhD
Phone 0142162979
Email guillaume.lebreton@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 recovery of cardiac function will have to happen within 15 days after transplantation.


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 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date September 2028
Est. primary completion date September 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Heart transplantation
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

Locations

Country Name City State
France Pitié-Salpêtrière Hospital Paris

Sponsors (4)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Centre Hospitalier Universitaire de Pointe-a-Pitre, ICAN Nutrition Education and Research, University Hospital Center of Martinique

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary Survival 15 days, 30 days, 9 months, 6 months and 12 months
Secondary 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
Secondary 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
Secondary Adverse events after transplant moderate or severe primary graft dysfunction (according to ISHLT consensus),
acute cell rejection >2R, VAD >1,
long-term circulatory support (LVAD, BiVAD, TAH)
15 days and 12 months
Secondary Myocardial preservation Absence of significant edema (pre- and post-preservation graft weight) during the procedure/surgery
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