Heart FailureNCT05881278
XVIVO Heart Perfusion System (XHPS) With Supplemented XVIVO Heart Solution (SXHS)
A study testing Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS) in people with Heart Failure and Transplant; Failure, Heart, run by XVIVO Perfusion at 20 sites in United States.
Trial summary
The purpose of this study is to evaluate if Non-Ischemic Heart Preservation (NIHP) of extended criteria donor hearts using the XVIVO Heart Preservation System (XHPS) is a safe and effective way to preserve and transport hearts for transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Transplant; Failure, Heart
- What is being tested?
- Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 20 sitesUnited States
- Study dates
- 10 Oct 2023to Nov 2029
- 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
Recipient Inclusion Criteria:
- Age ≥18 years.
- Signed informed consent form (ICF).
- Listed for heart transplantation
Recipient Exclusion Criteria:
- Previous solid organ or bone marrow transplantation.
- Requires a multi-organ transplant.
- Subject is enrolled and ongoing in another investigational pharmaceutical or medical device clinical trial (Exception: observational studies are permitted).
- Subject is on mechanical circulatory support pre-transplant other than durable LVAD, Impella or intra-aortic balloon pump.
- History of complex congenital heart disease ie: single ventricle physiology (Per Investigators discretion).
- Subject on renal replacement therapy/dialysis.
- Ventilator dependence (subject is intubated at time of transplant/unable to provide consent or re-affirmation of consent).
- Sensitized subject is undergoing desensitization treatment.
Donor Inclusion Criteria:
- Estimated Cross Clamp Time ≥ 4 hours, OR
- Estimated Cross Clamp Time ≥ 2 hours, AND Any ONE or more of the following:
- Age ≥ 50 years
- LVEF 40-50% at time of provisional acceptance
- Down-time ≥ 20 mins
- Hypertrophy/Septal thickness >12- ≤16mm
- Angiographic luminal irregularities with no significant CAD, OR
- Donation after Circulatory Death (DCD) donors.
Donor Exclusion Criteria:
- Unstable hemodynamics requiring high-dose inotropic support.
- Significantly abnormal coronary angiogram defined as CAD > 50% stenosis of one or more vessels.
- Moderate to severe cardiac valve pathology.
- Investigator's clinical decision to exclude from trial.
- Previous Sternotomy.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Emory University
Atlanta, Georgia, 30322
University of Maryland Medical Center/University of Maryland, Baltimore
Baltimore, Maryland, 21201
Johns Hopkins Medicine
Baltimore, Maryland, 21287
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43210
UT Southwestern Medical Center
Dallas, Texas, 75390
Duke University
Durham, North Carolina, 27710
University of California San Diego
La Jolla, California, 92037
Cedars-Sinai
Los Angeles, California, 90048
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
Vanderbilt University
Nashville, Tennessee, 37232
NYU Langone Health
New York, New York, 10016
Columbia University Irving Medical Center/New York Presbyterian Hospital
New York, New York, 10032
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Stanford Medicine
Palo Alto, California, 94304
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
University of Washington Medical Center
Seattle, Washington, 98195
Washington University - Barnes Jewish Hospital
St Louis, Missouri, 63110
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: PRESERVE Heart Study: A Prospective, Multi-center, Single-Arm, Open-Label Study of Hearts Transplanted After Non-Ischemic Heart PRESERVation From Extended Donors
The purpose of this study is to evaluate if Non-Ischemic Heart Preservation (NIHP) of extended criteria donor hearts using the XVIVO Heart Preservation System (XHPS) is a safe and effective way to preserve and transport hearts for transplantation.
Read the detailed description
PRESERVE Heart Study - This is a prospective, multicenter, non-randomized, single arm, open label study in subjects requiring a Heart Transplant. Study donor hearts meeting extended criteria are preserved via Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS).
- Conditions
- Heart Failure, Transplant; Failure, Heart
- Being tested
- Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)Device
Study donor hearts meeting extended criteria are preserved via Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)
| Study group | Role | What they receive |
|---|---|---|
| Subjects requiring a Heart Transplant | Experimental | Device: Preservation of hearts for transplant. Receives: Device: Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patient survival
The percentage of patient survival at 365 days from the date of transplant. The long-term safety success is defined as survival.
Measured: Post-operative Day 365.
The percentage of patient treatment success rate
The percentage of patient treatment success rate at 30-days post transplantation. The treatment success is defined as freedom from treatment failure.
Measured: 30 days post transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start10 Oct 2023
- Primary completion22 Nov 2025
- Study completionNov 2029 (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
- 141 participants (estimated)
Sponsor and investigators
- Lead sponsor
- XVIVO Perfusion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Lowe, Study director, XVIVO Perfusion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881278
- Sponsor's protocol ID
- NIHP - 001
- Status last verified
- Mar 2026
- First submitted
- 18 May 2023
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRESERVE Heart Study: A Prospective, Multi-center, Single-Arm, Open-Label Study of Hearts Transplanted After Non-Ischemic Heart PRESERVation From Extended Donors
- ClinicalTrials.gov ID
- NCT05881278
- Acronym / sponsor ID
- NIHP - 001
- Conditions
- Heart Failure, Transplant; Failure, Heart
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 141 participants (estimated)
- Lead sponsor
- XVIVO PerfusionIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 22 Nov 2025 (actual)
- Study completion
- Nov 2029 (estimated)
- First posted
- 31 May 2023 (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 this study is to evaluate if Non-Ischemic Heart Preservation (NIHP) of extended criteria donor hearts using the XVIVO Heart Preservation System (XHPS) is a safe and effective way to preserve and transport hearts for transplantation.
Detailed description
PRESERVE Heart Study - This is a prospective, multicenter, non-randomized, single arm, open label study in subjects requiring a Heart Transplant. Study donor hearts meeting extended criteria are preserved via Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects requiring a Heart Transplant | Experimental | Device: Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)Device: Preservation of hearts for transplant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)Study donor hearts meeting extended criteria are preserved via Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS) | Device | Subjects requiring a Heart Transplant |
Primary outcome
The percentage of patient survival
Time frame: Post-operative Day 365.
The percentage of patient survival at 365 days from the date of transplant. The long-term safety success is defined as survival.
The percentage of patient treatment success rate
Time frame: 30 days post transplantation
The percentage of patient treatment success rate at 30-days post transplantation. The treatment success is defined as freedom from treatment failure.
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 17 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.
Sarah Lowe study director
XVIVO Perfusion
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS) in people with Heart Failure and Transplant; Failure, Heart, run by XVIVO Perfusion at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 17 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 20 sites in United States. 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?
The percentage of patient survival (time frame: Post-operative Day 365.). The study lists 2 primary outcomes in all. 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 17 Aug 2026.