Clinical trial NCT06485596: HOPE At Heart (HOPE) of Donor Hearts After Circulatory Death (DCD) Using the XVIVO Heart Assist Transport System.
Official title: Direct Procurement (DP) and Hypothermic Oxygenated Perfusion (HOPE) of Donor Hearts After Circulatory Death (DCD) Using the XVIVO Heart Assist Transport System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: XVIVO Perfusion
Sponsor class: INDUSTRY
First posted: 2024-07-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years
2. Signed informed consent form
3. Accepted and/or listed for heart transplantation

Exclusion Criteria:

1. Not able to understand the information provided during the informed consent procedure
2. Previous solid organ transplantation
3. Grown-up congenital heart disease
4. Dialysis
5. Incompatible blood group
6. Combined organ transplantation candidates
7. Subjects under pre-transplant desensitization protocol (including plasma exchange in conjunction with the transplant surgery)
8. Mechanical circulatory support pre-transplantation (except durable Left ventricular assist device or Intra-aortic balloon pump)

Primary outcomes:
measure: Patient survival
timeFrame: 30 days post-transplant
Secondary outcomes:
measure: Cardiac related mortality
timeFrame: 30 days post-transplant
measure: Incidence of Mechanical circulatory support
timeFrame: 30 days post-transplant
measure: Incidence of severe Primary Graft Dysfunction (PGD) at 24 hours post-transplant (Kobashigawa et al., 2014)
timeFrame: 30 days post-transplant
measure: Cardiac function as assessed by left ventricular ejection fraction (LVEF) at 24 hours and 30 days post-transplant
timeFrame: 30 days post-transplant
measure: Incidence of perfused hearts which are not used for transplantation
timeFrame: 30 days post-transplant
measure: Total duration of ICU stay (days)
timeFrame: 30 days post-transplant
measure: Incidence of biopsy proven rejections > 1 ACR (leading to changed immunosuppressive regime)
timeFrame: 30 days post-transplant
measure: Cardiac related mortality at 6 months post-transplant
timeFrame: 6 months post-transplant
measure: Cardiac function as assessed by left ventricular ejection fraction (LVEF)
timeFrame: 6 months post-transplant
measure: Number of days until hospital discharge from index procedure
timeFrame: 30 days post-transplant
measure: Incidence of biopsy proven rejections > 1 ACR (leading to changed immunosuppressive regime)
timeFrame: 6 months post-transplant
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Filip Rega, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: