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10 Degree C Static Storage in Heart Transplantation
Sponsor: John Trahanas
Summary
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
Official title: Feasibility Study of 10 Degree C Static Storage in Human Heart Transplantation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
25
Start Date
2026-10
Completion Date
2029-07
Last Updated
2026-09-14
Healthy Volunteers
No
Interventions
10 degree C Static Storage Cooler
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.
Locations (1)
Vanderbilt University Medical Center
Nashville, Tennessee, United States