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

Korábbi kezelés

• Previous solid organ or bone marrow transplantation.
• Requires a multi-organ transplant.
• Subject is on mechanical circulatory support pre-transplant other than durable LVAD, Impella or intra-aortic balloon pump (IABP).
• Subject on renal replacement therapy/dialysis.
• Ventilator dependence (subject is intubated at time of transplant/unable to provide consent or re-affirmation of consent).
• 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:
• Previous sternotomy.

Más betegség

• History of complex congenital heart disease ie: single ventricle physiology (per Investigator's discretion and XVIVO review).
• 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:
• 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.
• Moderate to severe cardiac valve pathology.

Laborértékek

• LVEF 40% - 50% at time of provisional acceptance. (Refer to section 6.3.4 for definition of provisional acceptance).

Életkor

• Age ≥50 years

Egyéb

• Subject is enrolled and ongoing in another investigational pharmaceutical or medical device clinical trial (Exception: observational studies are permitted).
• Estimated Cross Clamp Time ≥4 hours OR
• Estimated Cross Clamp ≥ 2 hours AND
  • Any one or more of the following:
• Down-time ≥20 minutes
• Hypertrophy septal thickness >12 - ≤16mm
• Unstable hemodynamics requiring high-dose inotropic support.
• Investigator's clinical decision to exclude from trial.

• To be eligible to participate in this study, a recipient must meet all the following criteria:
• Age ³18 years.
• Signed informed consent form (ICF).
• Listed for heart transplantation.