Première Evaluation Clinique de la Transplantation Cardiaque de Greffons préservés à l'Aide d'un Système de Perfusion Ex-vivo prolongée
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Short term recovery of Cardiac function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Short term recovery of Cardiac function
时间窗: Within 15 days after transplantation
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
次要结局
- Survival(15 days, 30 days, 9 months, 6 months and 12 months)
- Absence of cardiac deaths(15 days, 30 days, 3 months, 6 months and 12 months)
- Myocardial preservation(during the procedure/surgery)
- Cardiac function recovery(30 days, 3months, 6 months and 12 months)
- Adverse events after transplant(15 days and 12 months)