Heart Failure, Heart Transplant, Transplant, Failure, Heart
Conditions
Keywords
10 degree C, Heart Transplant, Traferox, X° Port Heart Preservation
Brief 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. 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.
Interventions
DEVICE10 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.
Sponsors
John Trahanas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evidence of severe primary graft dysfunction (PGD) | 24 hours post-transplant | Evidence of severe PGD, as defined by the International Society of Heart and Lung Transplantation 2014 Consensus Document |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The need for venoarterial extracorporeal membrane oxygenation (ECMO) support | 24 hours postoperatively | Subject requires venoarterial ECMO support within the first 24 hours postoperatively |
| Peak 24-hour lactate level | 24 hours postoperatively | Peak 24-hour lactate level (millimoles/Liter) |
| Calculated vasoactive inotrope score (VIS) | 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 | 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) |
| 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 | Cardiac Index |
Countries
United States
Contacts
CONTACTJohn Trahanas, MD
Outcome results
None listed