RecruitingNot Applicable

XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP)

United States60 participantsStarted 2025-07-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ³18 years.
✓. Signed informed consent form (ICF).
✓. Listed for heart transplantation.

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 (IABP).
✕. History of complex congenital heart disease ie: single ventricle physiology (per Investigator's discretion and XVIVO review).
✕. 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 participants meeting any of the following:

What they're measuring

The percentage of patient treatment success rate

Timeframe: 30 days post transplantation

The percentage of patient survival

Timeframe: Post-operative Day 365.

Trial details

NCT IDNCT06895070

SponsorXVIVO Perfusion

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05

Contact for this trial

Amanda Carpenter

617-283-8332 Amanda.Carpenter@xvivogroup.com

View on ClinicalTrials.gov More Heart Transplant trials