XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorXVIVO Perfusion
About this trial
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
Qualifiers
Age ³18 years.
Signed informed consent form (ICF).
Listed for heart transplantation.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Assist Transport (XHAT)
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov