Heart FailureHOPE for AllNCT07556588
XVIVO Heart Transplant Study in Clinical Practice
A study testing XVIVO Heart Assist Transport System in people with Heart Failure, run by XVIVO Perfusion at 1 site in Belgium.
Trial summary
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. 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
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Aug 2024to 15 Apr 2028
- 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 or listed for heart transplantation
- 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
Who cannot join
- Not able to understand the information provided during the informed consent procedure
- Combined organ transplantation candidates
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, B-3000
Filip Rega, MD, PhD, +32 16 34 08 43, filip.rega@uzleuven.be
About this study
Official title: Application of Hypothermic Oxygenated Perfusion in Donor Heart Preservation in Clinical Practice - HOPE for All
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.
Read more
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.
Read the detailed description
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
- 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 Hypothermic oxygenated perfusion - HOPE, Direct procurment, Non-Ischemic Heart Preservation NIHP
Revised XHAT
| Study group | Role | What they receive |
|---|---|---|
| Preservation of DBD and DCD hearts for transplant. | Experimental | Not described 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 (12)
Cardiac related mortality at 30 days post-transplant
Measured: 30 days post-transplant
Incidence of Mechanical circulatory support within 30 days post-transplant
Measured: 30-days post-transplant
Incidence of severe Primary Graft Dysfunction (PGD) at 24 hours post-transplant
Measured: 24 hours post-transplant
Incidence of Primary Graft Dysfunction (PGD) RV at 24 hours post-transplant
Measured: 24 hours post-transplant
Cardiac function as assessed by left ventricular ejection fraction (LVEF) at 24 hours and 30 days post-transplant
Measured: 24 hours and 30 days post-transplant
Duration of initial ICU stay after the index procedure
Measured: 30-days post-transplant
Incidence of biopsy proven rejections > 1 ACR (leading to changed immunosuppressive regime) within 30 days post-transplant
Measured: 30 days post-transplant
Incidence of hearts perfused on the investigational device which is not used for transplantation
Measured: From enrollment to the end of recruitment
Cardiac related mortality at 6 and 12 months post-transplant
Measured: 6 and 12 months post-transplant
Cardiac function as assessed by left ventricular ejection fraction (LVEF) at 6 and 12 months post-transplant
Measured: 6 and 12 months post-transplant
Number of days until hospital discharge from index procedure 6 and 12 months post-transplant
Measured: 6 and 12 months post-transplant
Incidence of biopsy proven rejections > 1 ACR leading to changed immunosuppressive regime within 12 months post-transplant
Measured: Within 12 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 posted29 Apr 2026
- Study start3 Aug 2024
- Primary completion15 May 2027 (estimated)
- Study completion15 Apr 2028 (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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- XVIVO Perfusion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556588
- Sponsor's protocol ID
- HOPE for All CIV-25-11-055414
- Other IDs
- S71444
- Acronym
- HOPE for All
- Status last verified
- Aug 2026
- First submitted
- 9 Apr 2026
- Last updated
- 12 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 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Hypothermic Oxygenated Perfusion in Donor Heart Preservation in Clinical Practice - HOPE for All
- ClinicalTrials.gov ID
- NCT07556588
- Acronym / sponsor ID
- HOPE for All / HOPE for All CIV-25-11-055414
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- XVIVO PerfusionIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2024 (actual)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 Apr 2028 (estimated)
- First posted
- 29 Apr 2026 (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.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preservation of DBD and DCD hearts for transplant. | Experimental | Device: XVIVO Heart Assist Transport System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Signed informed consent form
- Accepted or listed for heart transplantation
- 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
Key exclusion criteria (6 listed)
- Not able to understand the information provided during the informed consent procedure
- Combined organ transplantation candidates
- 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
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: Hypothermic oxygenated perfusion - HOPE, Direct procurment, Non-Ischemic Heart Preservation NIHPRevised XHAT | Device | Preservation of DBD and DCD hearts for transplant. |
Primary outcome
Patient Survival
Time frame: 30 days post-transplant
12 secondary outcomes
Cardiac related mortality at 30 days post-transplant
Time frame: 30 days post-transplant
Incidence of Mechanical circulatory support within 30 days post-transplant
Time frame: 30-days post-transplant
Incidence of severe Primary Graft Dysfunction (PGD) at 24 hours post-transplant
Time frame: 24 hours post-transplant
Incidence of Primary Graft Dysfunction (PGD) RV at 24 hours post-transplant
Time frame: 24 hours post-transplant
Cardiac function as assessed by left ventricular ejection fraction (LVEF) at 24 hours and 30 days post-transplant
Time frame: 24 hours and 30 days post-transplant
Duration of initial ICU stay after the index procedure
Time frame: 30-days post-transplant
Incidence of biopsy proven rejections > 1 ACR (leading to changed immunosuppressive regime) within 30 days post-transplant
Time frame: 30 days post-transplant
Incidence of hearts perfused on the investigational device which is not used for transplantation
Time frame: From enrollment to the end of recruitment
Cardiac related mortality at 6 and 12 months post-transplant
Time frame: 6 and 12 months post-transplant
Cardiac function as assessed by left ventricular ejection fraction (LVEF) at 6 and 12 months post-transplant
Time frame: 6 and 12 months post-transplant
Number of days until hospital discharge from index procedure 6 and 12 months post-transplant
Time frame: 6 and 12 months post-transplant
Incidence of biopsy proven rejections > 1 ACR leading to changed immunosuppressive regime within 12 months post-transplant
Time frame: Within 12 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 12 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.
1 site in 1 country: 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 1 site in Belgium.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 12 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 1 site in 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?
Contact Filip Rega, MD, PhD (+32 16 34 08 43, filip.rega@uzleuven.be), or a site near the patient. 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 12 Aug 2026.