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

Heart Transplantation Clinical Trial

— PEGASE  

Official title:

Première Evaluation Clinique de la Transplantation Cardiaque de Greffons préservés à l'Aide d'un Système de Perfusion Ex-vivo prolongée

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06035991
• Other study ID #: APHP220091
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Heart Transplantation

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