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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Assist Transport (XHAT)
DeviceStudy donor hearts meeting extended criteria are preserved via Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Device: Preservation of hearts for transplant.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
30 days post transplantation2
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.
Time frame
Post-operative Day 365.Sponsors and contacts
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Source ClinicalTrials.gov