Open
Actively Recruiting
XVIVO Heart Perfusion System (XHPS) With Supplemented XVIVO Heart Solution (SXHS)
About
Brief 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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Recipient Inclusion Criteria:
- Age ≥18 years.
- Signed informed consent form (ICF).
- Listed for heart transplantation
Recipient 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.
Donor Inclusion Criteria:
- Estimated Cross Clamp Time ≥ 4 hours, OR
- Estimated Cross Clamp Time ≥ 2 hours, AND
Any ONE or more of the following:
- Age ≥ 50 years
- LVEF 40-50% at time of provisional acceptance
- Down-time ≥ 20 mins
- Hypertrophy/Septal thickness >12- ≤16mm
- Angiographic luminal irregularities with no significant CAD, OR
- Donation after Circulatory Death (DCD) donors.
Donor Exclusion Criteria:
- Unstable hemodynamics requiring high-dose inotropic support.
- Significantly abnormal coronary angiogram defined as CAD > 50% stenosis of one or more vessels.
- Moderate to severe cardiac valve pathology.
- Investigator's clinical decision to exclude from trial.
- Previous Sternotomy.
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Study Stats
Protocol No.
23-5202
Category
Heart/Cardiovascular Diseases
Immune System/Transplant Related Disorders
Principal Investigator
Contact
Location
- UCLA Westwood