10°C Storage for Heart Transplant
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Are You a Good Fit for This Trial?
This trial is for people with severe heart failure who are scheduled to receive a heart transplant. Participants must be eligible for a standard heart transplant procedure.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- 10 degree C Static Storage Cooler
Trial Overview
The study is testing if storing and transporting donor hearts at 10°C using the X°Port Heart Preservation System (XHPS) is safe and effective during heart transplantation. All participants will have their new hearts preserved this way.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Intervention: 10° C Heart Preservation
Find a Clinic Near You
Who Is Running the Clinical Trial?
John Trahanas
Lead Sponsor
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