NCT07818941Not yet recruiting
10 Degree C Static Storage in Heart Transplantation
Feasibility Study of 10 Degree C Static Storage in Human Heart Transplantation
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 8 Sept 2026
- Start date
- Oct 2026
- Primary completion date
- Jul 2028
- Lead sponsor
- John Trahanas
- Diseases
- Heart failure
- NCT number
- NCT07818941
What you commit to
- Study type: Interventional
- Planned participants: 25
- From Oct 2026 to the primary completion date, Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.