Heart TransplantNIHP-CAP-001NCT06895070
XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP)
A study testing Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Assist Transport (XHAT) in people with Heart Transplant and Heart Failure, run by XVIVO Perfusion at 14 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 Transplant, Heart Failure, Transplant; Failure, Heart
- What is being tested?
- Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Assist Transport (XHAT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 14 sitesUnited States
- Study dates
- 10 Jul 2025to May 2031
- 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
- To be eligible to participate in this study, a recipient must meet all the following criteria:
- Age ³18 years.
- Signed informed consent form (ICF).
- Listed for heart transplantation.
Who cannot join
- 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 (IABP).
- History of complex congenital heart disease ie: single ventricle physiology (per Investigator's discretion and XVIVO review).
- Subject on renal replacement therapy/dialysis.
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- Ventilator dependence (subject is intubated at time of transplant/unable to provide consent or re-affirmation of consent).
- Sensitized participants meeting any of the following:
- Participant with calculated Panel Reactive Antibody (cPRA) greater than 50%
- Participant undergoing any desensitization treatment (also with cPRA less than 50%)
- Participant with a positive prospective crossmatch and/or a positive virtual cross match
- Donor Inclusion Criteria:
- To be eligible to participate in this study, the donor heart must meet the following criteria:
- Estimated Cross Clamp Time ≥4 hours OR
- Estimated Cross Clamp ≥ 2 hours AND
- Any one or more of the following:
- Age ≥50 years
- LVEF 40% - 50% at time of provisional acceptance. (Refer to section 6.3.4 for definition of provisional acceptance).
- Down-time ≥20 minutes
- Hypertrophy septal thickness >12 - ≤16mm
- Angiographic luminal irregularities with no significant CAD OR 1) Donation after Circulatory Death (DCD)
- Donor Exclusion Criteria:
- Donor hearts that meet any of the following criteria will be excluded from transplantation in this study:
- Unstable hemodynamics requiring high-dose inotropic support.
- Significantly abnormal coronary angiogram defined as CAD > 50% stenosis of one or more vessels or if the donor heart exhibits any contusions, structural damage, gross abnormalities, or palpable CAD on final examination.
- Moderate to severe cardiac valve pathology.
- Investigator's clinical decision to exclude from trial.
- Previous sternotomy.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jen Ruel contact
14 sites in 1 country
United States14 sites, 14 recruiting
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
Emily Temponi, 404-712-1787, emily.k.temponi@emoryhealthcare.org
Mani Daneshmand, M.D.
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611-5969
Allison Mossell, 773-354-0756, Allison.mossell@nm.org
Benjamin Bryner, M.D.
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Sarah McNeil, 214-645-7728, sarah.mcneil@utsouthwestern.edu
Haley Mathis, 214-645-7709, haley.mathis@utsouthwestern.edu
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Rachel Rice, 919-602-3387, rachel.s.rice@duke.edu
Mary Motta, mary.motta@duke.edu
- Recruiting
UC San Diego Health
La Jolla, California, 92037
Andrew Stewart, 858-534-3793, a9stewart@health.ucsd.edu
Mark Kearns, M.D.
- Recruiting
Cedars Sinai Medical Center
Los Angeles, California, 90048
Jeremy Duenas, 310-248-7193, Jeremy.Duenas@csmns.org
Lucilla Garcia, 310-248-7197, Lucilla.Garcia@csmns.org
- Recruiting
University of California Los Angeles
Los Angeles, California, 90095-1405
Tahera Alnaseri, 425-435-0216, Talnaseri@mednet.ucla.edu
Steven Stokes, sstokes@mednet.ucla.edu
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Lisa Slinger, 615-875-2602, lisa.slinger@vumc.org
Ashish S Shah, M.D.
- Recruiting
NYU Langone
New York, New York, 10016
Jacquline Bott, jacqueline.bolt@nyulangone.org
Nader Moazami
- Recruiting
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, 10032
Bo Lu, 212-305-3009, bl2699@cumc.columbia.edu
Koji Takeda, M.D.
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 69198-2265
Mia Morrissey, M.S., 402-559-4601, mmorrissey1@unmc.edu
Ryan Ruskamp, 402-559-8084, ryan.ruskamp@unmc.edu
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98195
Shauna Andrus, 206-953-9970, sandrus@uw.edu
Jay Pal, M.D.
- Recruiting
Washington University - Barnes Jewish Health Hospital
St Louis, Missouri, 63110
James Hermeyer, 636-383-1721, hermeyer.j@wustl.edu
Kyle Stumbaugh, 636-317-9001, Kyles@wustl.edu
- Recruiting
Stanford University
Stanford, California, 94305
Lasemahang Limbu, 650-387-5852, limbul@stanford.edu
Tiffany Koyano, 650-206-0104, tkoyano3@stanford.edu
About this study
Official title: PRESERVE CAP: A Prospective, Multi-Center, Single-Arm, Open-Label Study of Hearts Transplanted After Non-Ischemic Heart Preservation From Extended Donors Continued Access Protocol
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
This is a continuation of the PRESERVE IDE trial to provide additional data evaluating the safety and effectiveness of the XVIVO Heart Assist Transport System. The PRESERVE Continued Access Protocol (CAP) will utilize the XHAT System to preserve donor hearts that may not meet current standard donor heart acceptance criteria with the intention of these hearts being transplanted. The CAP has been implemented to allow patients and physicians access to the XHAT System while a Post-Market Approval (PMA) application is being submitted and reviewed.
- Conditions
- Heart Transplant, Heart Failure, Transplant; Failure, Heart
- Being tested
- Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Assist Transport (XHAT)
- 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 Assist Transport (XHAT)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 |
|---|---|---|
| Device: Preservation of hearts for transplant. | Experimental | Device: Preservation of hearts for transplant. Receives: Device: Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Assist Transport (XHAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start10 Jul 2025
- Primary completionMay 2026 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart TransplantStudies 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
- 60 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
- NCT06895070
- Sponsor's protocol ID
- NIHP-CAP-001
- Acronym
- NIHP-CAP-001
- Status last verified
- Feb 2026
- First submitted
- 18 Mar 2025
- Last updated
- 18 Mar 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 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRESERVE CAP: A Prospective, Multi-Center, Single-Arm, Open-Label Study of Hearts Transplanted After Non-Ischemic Heart Preservation From Extended Donors Continued Access Protocol
- ClinicalTrials.gov ID
- NCT06895070
- Acronym / sponsor ID
- NIHP-CAP-001 / NIHP-CAP-001
- Conditions
- Heart Transplant, Heart Failure, Transplant; Failure, Heart
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- XVIVO PerfusionIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2031 (estimated)
- First posted
- 26 Mar 2025 (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
This is a continuation of the PRESERVE IDE trial to provide additional data evaluating the safety and effectiveness of the XVIVO Heart Assist Transport System. The PRESERVE Continued Access Protocol (CAP) will utilize the XHAT System to preserve donor hearts that may not meet current standard donor heart acceptance criteria with the intention of these hearts being transplanted. The CAP has been implemented to allow patients and physicians access to the XHAT System while a Post-Market Approval (PMA) application is being submitted and reviewed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device: Preservation of hearts for transplant. | Experimental | Device: Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Assist Transport (XHAT)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
Key inclusion criteria (4 listed)
- To be eligible to participate in this study, a recipient must meet all the following criteria:
- Age ³18 years.
- Signed informed consent form (ICF).
- Listed for heart transplantation.
Key exclusion criteria (28 listed)
- 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 (IABP).
- History of complex congenital heart disease ie: single ventricle physiology (per Investigator's discretion and XVIVO review).
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 Assist Transport (XHAT)Study donor hearts meeting extended criteria are preserved via Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS) | Device | Device: Preservation of hearts for transplant. |
Primary outcome
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.
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.
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 18 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Heart Transplant
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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.
Jen Ruel contact
Sarah Lowe study director
XVIVO Perfusion
14 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 Assist Transport (XHAT) in people with Heart Transplant and Heart Failure, run by XVIVO Perfusion at 14 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?
The sponsor lists 4 inclusion and 28 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 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
Contact Amanda Carpenter (617-283-8332, Amanda.Carpenter@xvivogroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patient treatment success rate (time frame: 30 days post transplantation). 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 18 Mar 2026.