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

Study Overview
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Brief Summary
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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.

Detailed Description
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PRESERVE Heart Study - This is a prospective, multicenter, non-randomized, single arm, open label study in subjects requiring a Heart Transplant. Study donor hearts meeting extended criteria are preserved via Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS).

Official Title
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PRESERVE Heart Study: A Prospective, Multi-center, Single-Arm, Open-Label Study of Hearts Transplanted After Non-Ischemic Heart PRESERVation From Extended Donors

Conditions
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Heart Failure, Transplant; Failure, Heart

Intervention / Treatment
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* Device: Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects requiring a Heart Transplant<br>Device: Preservation of hearts for transplant. | Device: Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)<br>* Study donor hearts meeting extended criteria are preserved via Non-Ischemic Heart Preservation (NIHP) using the XVIVO Heart Preservation System (XHPS)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Post-operative Day 365. | 
| 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. | 30 days post transplantation |