NCT06895070 XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP)
| NCT ID | NCT06895070 |
| Status | Recruiting |
| Phase | — |
| Sponsor | XVIVO Perfusion |
| Condition | Heart Transplant |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-07-10 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-07-10 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria Recipient: To be eligible to participate in this study, a recipient must meet all the following criteria: 1. Age ³18 years. 2. Signed informed consent form (ICF). 3. Listed for heart transplantation. Exclusion Criteria Recipient: 1. Previous solid organ or bone marrow transplantation. 2. Requires a multi-organ transplant. 3. Subject is enrolled and ongoing in another investigational pharmaceutical or medical device clinical trial (Exception: observational studies are permitted). 4. Subject is on mechanical circulatory support pre-transplant other than durable LVAD, Impella or intra-aortic balloon pump (IABP). 5. History of complex congenital heart disease ie: single ventricle physiology (per Investigator's discretion and XVIVO review). 6. Subject on renal replacement therapy/dialysis. 7. Ventilator dependence (subject is intubated at time of transplant/unable to provide consent or re-affirmation of consent). 8. 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: 1. Estimated Cross Clamp Time ≥4 hours OR 2. 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: 1. Unstable hemodynamics requiring high-dose inotropic support. 2. 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. 3. Moderate to severe cardiac valve pathology. 4. Investigator's clinical decision to exclude from trial. 5. Previous sternotomy.
Contact & Investigator
Sarah Lowe
STUDY DIRECTOR
XVIVO Perfusion
Frequently Asked Questions
Who can join the NCT06895070 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Transplant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06895070 currently recruiting?
Yes, NCT06895070 is actively recruiting participants. Contact the research team at Amanda.Carpenter@xvivogroup.com for enrollment information.
Where is the NCT06895070 trial being conducted?
This trial is being conducted at La Jolla, United States, Los Angeles, United States, Los Angeles, United States, Stanford, United States and 10 additional locations.
Who is sponsoring the NCT06895070 clinical trial?
NCT06895070 is sponsored by XVIVO Perfusion. The principal investigator is Sarah Lowe at XVIVO Perfusion. The trial plans to enroll 60 participants.