NCT06485596

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.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Aug 2024

Geographic Reach
2 countries

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

August 3, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
Last Updated

August 3, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

June 25, 2024

Last Update Submit

July 31, 2026

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Patient survival

    30 days post-transplant

Secondary Outcomes (11)

  • Cardiac related mortality

    30 days post-transplant

  • Incidence of Mechanical circulatory support

    30 days post-transplant

  • Incidence of severe Primary Graft Dysfunction (PGD) at 24 hours post-transplant (Kobashigawa et al., 2014)

    30 days post-transplant

  • Cardiac function as assessed by left ventricular ejection fraction (LVEF) at 24 hours and 30 days post-transplant

    30 days post-transplant

  • Incidence of perfused hearts which are not used for transplantation

    30 days post-transplant

  • +6 more secondary outcomes

Study Arms (1)

DCD Direct procurement

EXPERIMENTAL

Direct procurement of DCD donor hearts

Device: XVIVO Heart Assist Transport System

Interventions

XVIVO Heart Assist Transport SystemDEVICE

Direct procurement of donor hearts from DCD donation

Also known as: Direct procurement
DCD Direct procurement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Inclusion Recipient Criteria: 1. Age ≥18 years 2. Signed informed consent form 3. Accepted and/or listed for heart transplantation Exclusion Recipient 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) Inclusion - Heart donor 1. Accepted as a heart donor by the transplant team based on current standard of care criteria 2. DCD Maastricht category III and euthanasia donors 3. Age ≤ 60 years old Exclusion - Heart Donor 1. Functional warm ischemia time (FWIT) \> 30 minutes. 2. Donor cardiac arrest does not occur within 120 minutes from Withdrawal of life sustaining therapy (WLST) 3. Deviations from Donor end of life treatment protocol as defined by local standard operating procedures 4. Donor heart assessed as not transplantable by the responsible clinician at any time point during the donation or procurement procedure

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

UZ Leuven

Leuven, Belgium

Location

UMC Groningen

Groningen, 9713, Netherlands

Location

Erasmus MC

Rotterdam, 3015, Netherlands

Location

UMC Utrecht

Utrecht, 3584, Netherlands

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Filip Rega, MD, PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2024

First Posted

July 3, 2024

Study Start

August 3, 2024

Primary Completion

August 1, 2026

Study Completion

August 1, 2026

Last Updated

August 3, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)NL(3)