Heart FailureHOPE@HeartNCT06485596
HOPE at Heart (HOPE) of Donor Hearts After Circulatory Death (DCD) Using the XVIVO Heart Assist Transport System.
A study testing XVIVO Heart Assist Transport System in people with Heart Failure, run by XVIVO Perfusion at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- XVIVO Heart Assist Transport System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 3 Aug 2024to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Signed informed consent form
- Accepted and/or listed for heart transplantation
- Accepted as a heart donor by the transplant team based on current standard of care criteria
- DCD Maastricht category III and euthanasia donors
- Age ≤ 60 years old
Who cannot join
- 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
Show all 12Show fewer
- 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)
- Functional warm ischemia time (FWIT) > 30 minutes.
- Donor cardiac arrest does not occur within 120 minutes from Withdrawal of life sustaining therapy (WLST)
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Netherlands3 sites
UMC Groningen
Groningen, 9713
Erasmus MC
Rotterdam, 3015
UMC Utrecht
Utrecht, 3584
About this study
Official title: Direct Procurement (DP) and Hypothermic Oxygenated Perfusion (HOPE) of Donor Hearts After Circulatory Death (DCD) Using the XVIVO Heart Assist Transport System
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.
Read the 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 40 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.
- Conditions
- Heart Failure
- Being tested
- XVIVO Heart Assist Transport System
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XVIVO Heart Assist Transport SystemDevice
Also called Direct procurement
Direct procurement of donor hearts from DCD donation
| Study group | Role | What they receive |
|---|---|---|
| DCD Direct procurement | Experimental | Direct procurement of DCD donor hearts Receives: Device: XVIVO Heart Assist Transport System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient survival
Measured: 30 days post-transplant
Secondary outcomes (11)
Cardiac related mortality
Measured: 30 days post-transplant
Incidence of Mechanical circulatory support
Measured: 30 days post-transplant
Incidence of severe Primary Graft Dysfunction (PGD) at 24 hours post-transplant (Kobashigawa et al., 2014)
Measured: 30 days post-transplant
Cardiac function as assessed by left ventricular ejection fraction (LVEF) at 24 hours and 30 days post-transplant
Measured: 30 days post-transplant
Incidence of perfused hearts which are not used for transplantation
Measured: 30 days post-transplant
Total duration of ICU stay (days)
Measured: 30 days post-transplant
Incidence of biopsy proven rejections > 1 ACR (leading to changed immunosuppressive regime)
Measured: 30 days post-transplant
Cardiac related mortality at 6 months post-transplant
Measured: 6 months post-transplant
Cardiac function as assessed by left ventricular ejection fraction (LVEF)
Measured: 6 months post-transplant
Number of days until hospital discharge from index procedure
Measured: 30 days post-transplant
Incidence of biopsy proven rejections > 1 ACR (leading to changed immunosuppressive regime)
Measured: 6 months post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start3 Aug 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- XVIVO Perfusion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Filip Rega, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485596
- Sponsor's protocol ID
- HOPE at Heart
- Acronym
- HOPE@Heart
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2024
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Procurement (DP) and Hypothermic Oxygenated Perfusion (HOPE) of Donor Hearts After Circulatory Death (DCD) Using the XVIVO Heart Assist Transport System
- ClinicalTrials.gov ID
- NCT06485596
- Acronym / sponsor ID
- HOPE@Heart / HOPE at Heart
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- XVIVO PerfusionIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 40 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCD Direct procurement | Experimental | Device: XVIVO Heart Assist Transport SystemDirect procurement of DCD donor hearts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Signed informed consent form
- Accepted and/or listed for heart transplantation
- Accepted as a heart donor by the transplant team based on current standard of care criteria
- DCD Maastricht category III and euthanasia donors
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XVIVO Heart Assist Transport SystemAlso: Direct procurementDirect procurement of donor hearts from DCD donation | Device | DCD Direct procurement |
Primary outcome
Patient survival
Time frame: 30 days post-transplant
11 secondary outcomes
Cardiac related mortality
Time frame: 30 days post-transplant
Incidence of Mechanical circulatory support
Time frame: 30 days post-transplant
Incidence of severe Primary Graft Dysfunction (PGD) at 24 hours post-transplant (Kobashigawa et al., 2014)
Time frame: 30 days post-transplant
Cardiac function as assessed by left ventricular ejection fraction (LVEF) at 24 hours and 30 days post-transplant
Time frame: 30 days post-transplant
Incidence of perfused hearts which are not used for transplantation
Time frame: 30 days post-transplant
Total duration of ICU stay (days)
Time frame: 30 days post-transplant
Incidence of biopsy proven rejections > 1 ACR (leading to changed immunosuppressive regime)
Time frame: 30 days post-transplant
Cardiac related mortality at 6 months post-transplant
Time frame: 6 months post-transplant
Cardiac function as assessed by left ventricular ejection fraction (LVEF)
Time frame: 6 months post-transplant
Number of days until hospital discharge from index procedure
Time frame: 30 days post-transplant
Incidence of biopsy proven rejections > 1 ACR (leading to changed immunosuppressive regime)
Time frame: 6 months post-transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filip Rega, MD, PhD principal investigator
UZ Leuven
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XVIVO Heart Assist Transport System in people with Heart Failure, run by XVIVO Perfusion at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient survival (time frame: 30 days post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.