10 Degree C Static Storage in Heart Transplantation

N/ANot Yet RecruitingNCT07818941

John Trahanas25 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Transplant, Failure, Heart Heart Transplant Heart Failure

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

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