XVIVO Heart Transplant Study in Clinical Practice

Официальное название

Application of Hypothermic Oxygenated Perfusion in Donor Heart Preservation in Clinical Practice - HOPE for All

Обзор

HOPE for All is a clinical investigation to support the use of hypothermic oxygenated perfusion (HOPE) using a revised XVIVO Heart Assist Transport System in a real- world setting. The trial will investigate the application of HOPE in a broad population of Donation after Brain Death (DBD) and Donation after Circulatory Death (DCD) donor hearts transplanted to any listed adult patient. The hypothesis is that the use of HOPE is safe and feasible for any adult patient awaiting a heart transplantation. Primary objective is to evaluate patient survival in the real world setting after heart transplantation, where HOPE using the revised XVIVO Heart Assist Transport System is used for donor heart preservation. Secondary objective(s) are to evaluate patient outcomes and graft function post-transplant. HOPE for All is a prospective, single-armed single-centre proof-of-consept trial.

Подробное описание

HOPE for All will include a total of 20 subjects transplanted with donor hearts using the revised XVIVO Heart Assist Transport System and will evaluate transplant outcomes such as patient survival, post-transplant complications and graft function for a period of 12 months post-transplant.

The investigation will be conducted at 1 heart transplant center in Belgium who has thorough experience using the XVIVO Heart Assist Transport System for both DBD and DCD transplants.

The study will not include a control group as this is a proof-of-concept study

Вмешательства

• Устройство XVIVO Heart Assist Transport System
  Revised XHAT

Первичные конечные точки

• Patient Survival [Срок оценки: 30 days post-transplant]

Вторичные конечные точки (12)

• Cardiac related mortality at 30 days post-transplant [Срок оценки: 30 days post-transplant]
• Incidence of Mechanical circulatory support within 30 days post-transplant [Срок оценки: 30-days post-transplant]
• Incidence of severe Primary Graft Dysfunction (PGD) at 24 hours post-transplant [Срок оценки: 24 hours post-transplant]
• Incidence of Primary Graft Dysfunction (PGD) RV at 24 hours post-transplant [Срок оценки: 24 hours post-transplant]
• Cardiac function as assessed by left ventricular ejection fraction (LVEF) at 24 hours and 30 days post-transplant [Срок оценки: 24 hours and 30 days post-transplant]
• Duration of initial ICU stay after the index procedure [Срок оценки: 30-days post-transplant]
• Incidence of biopsy proven rejections > 1 ACR (leading to changed immunosuppressive regime) within 30 days post-transplant [Срок оценки: 30 days post-transplant]
• Incidence of hearts perfused on the investigational device which is not used for transplantation [Срок оценки: From enrollment to the end of recruitment]
• Cardiac related mortality at 6 and 12 months post-transplant [Срок оценки: 6 and 12 months post-transplant]
• Cardiac function as assessed by left ventricular ejection fraction (LVEF) at 6 and 12 months post-transplant [Срок оценки: 6 and 12 months post-transplant]
• Number of days until hospital discharge from index procedure 6 and 12 months post-transplant [Срок оценки: 6 and 12 months post-transplant]
• Incidence of biopsy proven rejections > 1 ACR leading to changed immunosuppressive regime within 12 months post-transplant [Срок оценки: Within 12 months post-transplant]

Критерии участия

Inclusion Criteria Recipient:

• Age ≥18 years
• Signed informed consent form
• Accepted or listed for heart transplantation

Inclusion Criteria Heart Donor:

• Accepted as a heart donor by the transplant team based on current standard of care criteria
• DBD or DCD Maastricht category III or euthanasia donors

Exclusion Criteria Recipient:

• Not able to understand the information provided during the informed consent procedure
• Combined organ transplantation candidates

Exclusion Criteria Heart Donor:

• Functional warm ischemia time (FWIT) > 30 minutes (DCD).
• Donor cardiac arrest does not occur within 120 minutes from Withdrawal of life sustaining therapy (DCD)
• Deviations from Donor end of life treatment protocol as defined by local standard operating procedures
• Donor heart assessed as not transplantable by the responsible clinician at any time point during the donation or procurement procedure

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• UZ Leuven — Leuven

Идентификаторы

NCT: NCT07556588 · HOPE for All CIV-25-11-055414 · S71444

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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