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

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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.

Not a fit? Find another study