10 Degree C Static Storage in Heart Transplantation

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; Heart Transplant; Transplant, Failure, Heart
• Intervention / Treatment: Device: 10 degree C Static Storage Cooler

Detailed Description

This is a single-arm, prospective, open-label, single-center clinical study enrolling patients requiring a heart transplant. All hearts will be preserved with the X°Port Heart Preservation System (XHPS) using 10°C preservation, above freezing but below physiological levels, to slow metabolic activity while minimizing cellular injury. Traditional organ preservation involves preservation with ice at temperatures near or below 4°C.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John Trahanas, MD; Phone Number: 615-343-9195; Email: john.trahanas@vumc.org

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
      • Contact: John Trahanas, MD; Email: john.trahanas@vumc.org
      • Principal Investigator: John Trahanas, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects Requiring Heart a Transplant; Intervention: 10° C Heart Preservation	Device: 10 degree C Static Storage Cooler; The X°Port HPS (Heart Preservation System) is a portable, insulated device designed to maintain donor hearts at an optimal preservation temperature (4°C to 10°C) during static cold storage and transport. The system uses pre-conditioned cooling packs arranged in both the base and lid compartments to create a sub-normothermic thermal environment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evidence of severe primary graft dysfunction (PGD)	Evidence of severe PGD, as defined by the International Society of Heart and Lung Transplantation 2014 Consensus Document	24 hours post-transplant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The need for venoarterial extracorporeal membrane oxygenation (ECMO) support	Subject requires venoarterial ECMO support within the first 24 hours postoperatively	24 hours postoperatively
Peak 24-hour lactate level	Peak 24-hour lactate level (millimoles/Liter)	24 hours postoperatively
Calculated vasoactive inotrope score (VIS)	Calculated VIS, which includes the following pressor medications: dobutamine, dopamine, milrinone, epinephrine, norepinephrine and vasopressin (in micrograms/kilogram/minute, except vasopressin in Units/kilogram/minute)	1) immediately postoperatively, upon arrival to the intensive care unit (ICU) and 2) at 24 hours and 3) at 72 hours from anesthesia stop time
Cardiac Index	Cardiac Index	1) immediately postoperatively, upon arrival to the intensive care unit (ICU) and 2) at 24 hours and 3) at 72 hours from anesthesia stop time, if collected

Collaborators and Investigators

• Sponsor: John Trahanas

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: September 8, 2026
• First Submitted That Met QC Criteria: September 8, 2026
• First Posted (Actual): September 14, 2026

Study Record Updates

• Last Update Posted (Actual): September 14, 2026
• Last Update Submitted That Met QC Criteria: September 8, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Heart Transplant; Traferox; 10 degree C; X° Port Heart Preservation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 261005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to institutional policies and the need to protect participant confidentiality

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes