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NCT07818941
10 Degree C Static Storage in Heart Transplantation
Conditions: Transplant, Failure, Heart, Heart Transplant, Heart Failure
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 25
Sponsor: John Trahanas
Location: Vanderbilt University Medical Center Nashville Tennessee
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
Eligibility Criteria
Recipient Inclusion Criteria:
* Age \>=18 years old
* Listed for heart transplantation
* Consented for the research study (signed Informed Consent Form)
Recipient Exclusion Criteria:
* Multi-organ transplant (i.e., heart-liver, heart-kidney, heart-lung)
* Previous solid organ or bone marrow transplant
* Complex congenital etiology of heart failure
Donor Inclusion Criteria:
* Donation after brain death or donation after circulatory death heart donors
* Donor hearts that have been allocated to VUMC as a primary match offer prior to organ procurement will be eligible.
Donor Exclusion Criteria:
* Donor hearts that have been allocated to VUMC as a backup offer
* Donor hearts that have been allocated to VUMC as a post-procurement offer
* Donor hearts that have already been placed on ice
Source: ClinicalTrials.gov (NCT07818941). StuddyBuddy aggregates publicly available trial information.