10 Degree C Static Storage in Heart Transplantation

Part of paid clinical trials in Nashville, Tennessee.

Sponsor: John Trahanas
Study ID: NCT07818941
Status: Not Yet Recruiting

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Conditions

Heart Failure
Heart Transplant
Transplant, Failure, Heart

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

10 degree C Static Storage Cooler — DEVICE
The X°Port HPS (Heart Preservation System) is a portable, insulated device designed to maintain donor hearts at an optimal preservation temperature (4°C to 10°C) during static cold storage and transport. The system uses pre-conditioned cooling packs arranged in both the base and lid compartments to create a sub-normothermic thermal environment.

Study Details

The goal of this clinical trial is to conduct a feasibility investigation evaluating the preliminary safety and effectiveness of using the X°Port Heart Preservation System (XHPS) for 10°C preservation in clinical heart transplantation. Participants will: * undergo a standard heart transplant, with a donor heart preserved and transported at 10°C using the XHPS. * have data collected at key timepoints related to their recovery in the ICU and hospital * return after discharge for standard follow-up appointments, with capture of standard data collected