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10 Degree C Static Storage in Heart Transplantation

Feasibility Study of 10 Degree C Static Storage in Human Heart Transplantation

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the early safety of the X°Port Heart Preservation System and how well it works to store and move donor hearts at 10°C. It is for adults listed for a heart transplant. The study team will collect recovery data during the hospital stay and at regular follow-up visits.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Heart recipients must be at least 18 years old.
  • Heart recipients must be listed for a heart transplant.
  • Heart recipients must sign a form agreeing to join the study.
  • Donors may give a heart after brain death or after the heart and blood flow have stopped.
  • Donor hearts must be offered to VUMC as the first-choice match before they are removed from the donor.

Who can't join

  • Recipients getting a heart and another organ transplant together.
  • Recipients who have already had a solid organ or bone marrow transplant.
  • Recipients whose heart failure comes from a complex heart problem present at birth.
  • Donor hearts offered to VUMC as a backup choice.
  • Donor hearts offered to VUMC after being removed from the donor.
  • Donor hearts that have already been placed on ice.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

TN