Transplant, Failure, HeartNCT07818941
10 Degree C Static Storage in Heart Transplantation
A study testing 10 degree C Static Storage Cooler in people with Transplant, Failure, Heart and Heart Transplant, run by John Trahanas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant, Failure, Heart, Heart Transplant, Heart Failure
- What is being tested?
- 10 degree C Static Storage Cooler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
John Trahanas, MD, john.trahanas@vumc.org
John Trahanas, MD
About this study
Official title: 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
Read the 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.
- Conditions
- Transplant, Failure, Heart, Heart Transplant, Heart Failure
- Being tested
- 10 degree C Static Storage Cooler
- Keywords
- 10 degree C, Heart Transplant, Traferox, X° Port Heart Preservation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 degree C Static Storage CoolerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects Requiring Heart a Transplant | Experimental | Intervention: 10° C Heart Preservation Receives: Device: 10 degree C Static Storage Cooler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours post-transplant
Secondary outcomes (4)
The need for venoarterial extracorporeal membrane oxygenation (ECMO) support
Subject requires venoarterial ECMO support within the first 24 hours postoperatively
Measured: 24 hours postoperatively
Peak 24-hour lactate level
Peak 24-hour lactate level (millimoles/Liter)
Measured: 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)
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant, Failure, HeartStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John Trahanas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John Trahanas, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818941
- Sponsor's protocol ID
- 261005
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared due to institutional policies and the need to protect participant confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of 10 Degree C Static Storage in Human Heart Transplantation
- ClinicalTrials.gov ID
- NCT07818941
- Acronym / sponsor ID
- 261005
- Conditions
- Transplant, Failure, Heart, Heart Transplant, Heart Failure
- Keywords
- 10 degree C, Heart Transplant, Traferox, X° Port Heart Preservation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- John TrahanasUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects Requiring Heart a Transplant | Experimental | Device: 10 degree C Static Storage CoolerIntervention: 10° C Heart Preservation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10 degree C Static Storage CoolerThe 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. | Device | Subjects Requiring Heart a Transplant |
Primary outcome
Evidence of severe primary graft dysfunction (PGD)
Time frame: 24 hours post-transplant
Evidence of severe PGD, as defined by the International Society of Heart and Lung Transplantation 2014 Consensus Document
4 secondary outcomes
The need for venoarterial extracorporeal membrane oxygenation (ECMO) support
Time frame: 24 hours postoperatively
Peak 24-hour lactate level
Time frame: 24 hours postoperatively
Calculated vasoactive inotrope score (VIS)
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional policies and the need to protect participant confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10 degree C Static Storage Cooler in people with Transplant, Failure, Heart and Heart Transplant, run by John Trahanas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Trahanas, MD (615-343-9195, john.trahanas@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of severe primary graft dysfunction (PGD) (time frame: 24 hours post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.