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10 Degree C Static Storage in Heart Transplantation

ConditionsTransplant, Failure, HeartHeart TransplantHeart Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohn Trahanas

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >=18 years old

Listed for heart transplantation

Consented for the research study (signed Informed Consent Form)

Disqualifiers

Multi-organ transplant (i.e., heart-liver, heart-kidney, heart-lung)

Previous solid organ or bone marrow transplant

Complex congenital etiology of heart failure

Donation after brain death or donation after circulatory death heart donors

Trial design

Design model

Single group

Treatments tested in this trial

  • 10 degree C Static Storage Cooler

    Device

    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.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Subjects Requiring Heart a TransplantExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

Peak 24-hour lactate level

Peak 24-hour lactate level (millimoles/Liter)

Time frame
24 hours postoperatively
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

John Trahanas

Lead sponsor

Vanderbilt University Medical Center

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: