Active — Not RecruitingNot Applicable

XVIVO Heart Perfusion System (XHPS) With Supplemented XVIVO Heart Solution (SXHS)

United States141 participantsStarted 2023-10-10

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 ≥18 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.
✕. 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.

What they're measuring

The percentage of patient survival

Timeframe: Post-operative Day 365.

The percentage of patient treatment success rate

Timeframe: 30 days post transplantation

Trial details

NCT IDNCT05881278

SponsorXVIVO Perfusion

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-22

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