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Not Yet Recruiting 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07818941). StuddyBuddy aggregates publicly available trial information.