An interventional study of 10 degree C Static Storage Cooler in Transplant, Failure, Heart, Heart Transplant and Heart Failure, sponsored by John Trahanas. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by John Trahanas · Not applicable, Interventional, and Treatment
Device received 510 (k) clearance
Among 2,157 studies in Heart Failure with a site in United States — 346 open to participants now, 437 under way, 27 of them phase 3. Heart Failure · United States.
Among the 2,157 studies in Heart Failure with a site in United States, this one is the 1,522nd largest by enrollment of the 1,601 interventional ones that give a count, is one of 95 that started in 2026, is one of 886 with no phase, and was the 2,149th registered.
6,332 studies on the registry are indexed under Heart Failure; 1,392 are open to participants now.
Browse Heart Failure studies →346 of the 2,157 studies in Heart Failure with a site in United States are open now. Recruiting first, the newest first:
Bettina Mittendorfer · Sites in United States
Ages 18–100 · Healthy volunteers
Mayo Clinic · Sites in United States
Ages 18–80
AnaCardio AB · Sites in United States, Bulgaria, Canada and 5 more countries
Ages 18–85
Mayo Clinic · Sites in United States
Ages 18–80 · Healthy volunteers
Tufts Medical Center · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 966 Heart Failure studies recruiting now, 689 (71%) set no upper age limit and 89 (9%) stop at 75 or younger; 63 take children under 18; 96 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
2,157 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 174 · Phase 2 313 · Phase 3 177 · Phase 4 139
First in 1983; this study’s year is marked. 95 started in 2026.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 65 across the 1,601 interventional studies, 150 across the 551 observational. Of the 1,509 that completed or were terminated, 629 (42%) have results posted.
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746 of 2,157 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with John Trahanas as lead sponsor.
John Trahanas has 1 study filed under Heart Failure — fewer than ten, so there is no comparison to draw.
135 of the studies in Heart Failure with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02901184Phase 3Uppsala UniversitySpironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction | 2026-12 |
| NCT06307652Phase 3AstraZenecaStudy to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function | 2027-04-16 |
| NCT06736574Phase 3CytokineticsStudy With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction | 2027-09 |
| NCT06024746Phase 3Colorado Prevention CenterA Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF) | 2027-11 |
| NCT06008197Phase 3Colorado Prevention CenterA Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients | 2027-11 |
Add all 135 to your calendar (.ics) → With an account.
Among the 2,157 studies in Heart Failure with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
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.
Recipient Inclusion Criteria:
Recipient Exclusion Criteria:
Donor Inclusion Criteria:
Donor Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
Time frame: 24 hours post-transplant
The need for venoarterial extracorporeal membrane oxygenation (ECMO) support
Subject requires venoarterial ECMO support within the first 24 hours postoperatively
Time frame: 24 hours postoperatively
Peak 24-hour lactate level
Peak 24-hour lactate level (millimoles/Liter)
Time frame: 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)
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
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
Plan to share: No — Individual participant data will not be shared due to institutional policies and the need to protect participant confidentiality
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jul 2028, 21 months later.
How these figures are worked out, and which studies are left out of them.
Device received 510 (k) clearance
Device received 510 (k) clearance
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is withdrawn, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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