HOPE At Heart (HOPE) of Donor Hearts After Circulatory Death (DCD) Using the XVIVO Heart Assist Transport System.
- Conditions
- Heart Failure
- Interventions
- Device: XVIVO Heart Assist Transport System
- Registration Number
- NCT06485596
- Lead Sponsor
- XVIVO Perfusion
- Brief Summary
The purpose of the clinical investigation is to support the use of direct procurement of donor hearts in donation after circulatory death followed by hypothermic oxygenated perfusion using the XVIVO Heart Assist Transport System. Thereby increasing the utilization of DCD donor hearts in donation after circulatory death.
The primary objective is to evaluate patient survival after direct procurement and hypothermic oxygenated machine perfusion of DCD donor hearts using the XVIVO Heart Assist Transport System.
The secondary objectives are to evaluate patient outcomes and graft function post-transplant.
- Detailed Description
This is a prospective, single-arm, multi-national, multicentre, proof-of-concept study to evaluate post-transplant outcomes after the use of direct procurement followed by a period of hypothermic oxygenated perfusion of the donor heart in DCD using the XVIVO Heart Assist Transport system.
The investigation will be conducted at 4 heart transplant centres, one in Belgium and three in The Netherlands.The study will include 20 DCD heart transplant recipients and will evaluate transplant outcomes such as post-transplant complications, patient survival and graft function for a period of 6 months post-transplant.
The study will not include a control group as this is a proof-of-concept study, investigating an alternative method of procurement of DCD hearts by providing additional safety and performance data.
The primary objective is to evaluate patient survival after direct procurement and hypothermic oxygenated machine perfusion of DCD donor hearts using the XVIVO Heart Assist Transport System.
The secondary objectives are to evaluate patient outcomes and graft function post-transplant.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Age ≥18 years
- Signed informed consent form
- Accepted and/or listed for heart transplantation
- Not able to understand the information provided during the informed consent procedure
- Previous solid organ transplantation
- Grown-up congenital heart disease
- Dialysis
- Incompatible blood group
- Combined organ transplantation candidates
- Subjects under pre-transplant desensitization protocol (including plasma exchange in conjunction with the transplant surgery)
- Mechanical circulatory support pre-transplantation (except durable Left ventricular assist device or Intra-aortic balloon pump)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DCD Direct procurement XVIVO Heart Assist Transport System Direct procurement of DCD donor hearts
- Primary Outcome Measures
Name Time Method Patient survival 30 days post-transplant
- Secondary Outcome Measures
Name Time Method Cardiac function as assessed by left ventricular ejection fraction (LVEF) at 24 hours and 30 days post-transplant 30 days post-transplant Cardiac related mortality 30 days post-transplant Total duration of ICU stay (days) 30 days post-transplant Incidence of biopsy proven rejections > 1 ACR (leading to changed immunosuppressive regime) 6 months post-transplant Incidence of Mechanical circulatory support 30 days post-transplant Incidence of perfused hearts which are not used for transplantation 30 days post-transplant Cardiac function as assessed by left ventricular ejection fraction (LVEF) 6 months post-transplant Incidence of severe Primary Graft Dysfunction (PGD) at 24 hours post-transplant (Kobashigawa et al., 2014) 30 days post-transplant Cardiac related mortality at 6 months post-transplant 6 months post-transplant Number of days until hospital discharge from index procedure 30 days post-transplant
Trial Locations
- Locations (1)
UZ Leuven
🇧🇪Leuven, Belgium