Heart Failure
Conditions
Keywords
Heart Failure, Transplant, Warm Perfusion, Organ Care, Resting Mode
Brief summary
The purpose of the study is to compare survival of both patients and newly transplanted hearts following heart transplantation among patients who were transplanted with donated hearts preserved on ice and those who were transplanted with donated hearts using the Organ Care System (OCS). The Organ care system preserves the hearts in a warm blood perfused beating state. The study also compares the number of rejection episodes, heart related adverse events, ICU time, and ventilation time between the two groups. The study is considered a success if survival in the OCS group was not inferior to the ice group.
Interventions
DEVICEOrgan Care System
The Organ Care System (OCS) is a portable organ perfusion and monitoring system intended to preserve a donated heart in a near normal physiologic beating state during transport for eventual transplantation into a recipient. The OCS maintains organ viability by providing a controlled environment that simulates near-normal physiological conditions, continuously perfusing the donated heart with warm, oxygenated blood, supplemented with the Solution Set. The blood is collected from the donor and continuously circulated to the organ in a closed circuit along with the Solution. The OCS preserves and monitors the organ's perfusion and metabolic state after explantation from a donor and connection to the device, during transportation to the recipient site, and until disconnection from the device.
DEVICECold Cardioplegia Solution
This is the standard of care solutions used to arrest and preserve the donated heart during transport until arrival at recipient hospital
Sponsors
University of California, Los Angeles
Columbia University
The Cleveland Clinic
Massachusetts General Hospital
Newark Beth Israel Medical Center
Cedars-Sinai Medical Center
Groupe Hospitalier Pitie-Salpetriere
Papworth Hospital NHS Foundation Trust
Azienda Ospedaliera S. Maria della Misericordia
Royal Brompton & Harefield NHS Foundation Trust
Indiana University
TransMedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Recipient Day of Transplant * Registered male or female primary heart transplant candidate * ≥18 years old * Signed, written informed consent document and authorization to use and disclose protected health information Donor Hearts * \<60 years old * Mean systolic blood pressure \>60 mmHg at the time of final heart assessment * Satisfactory echocardiography assessment defined as: * Ejection fraction \>40% * Absence of severe segmental wall motion abnormalities * Absence of left ventricular hypertrophy (inter ventricular septum and posterior wall thickness \<1.3 cm) * Absence of valve abnormalities (trace to mild valvular regurgitation is acceptable)
Exclusion criteria
Recipient Day of Transplant * \>4 previous sternotomies * Chronic renal failure as defined by chronic serum creatinine \>3.0 mg/dL for more than 2 weeks and/or requiring hemodialysis (except for hemodialysis or hemofiltration for fluid overload) * Ventilator dependence at the time of transplant * Use of a ventricular assist device for \> 30 days and the presence of any of the following: sepsis, intracranial hemorrhage or heparin induced thrombocytopenia * Panel reactive antibodies \> 40% with a positive prospective cross match and/or virtual cross match * Use of an investigational drug or device, other than OCS, during the study. * Simultaneous transplant of non-heart allograft, except for concurrent kidney transplant Donor Hearts * Abnormal coronary angiogram defined as \>50% stenosis, requiring coronary bypass * Donor-to-recipient body weight ratio of \<0.6 * Inotrope support at time of final heart assessment including, but not limited to: * Dopamine \>10 ug/kg/min * Dobutamine \> 10 ug/kg/min * Milrinone \>0.3 ug/kg/min * Epinephrine \> 0.03 ug/kg/min * Norepinephrine \> 0.03 ug/kg/min * Any bolus dose of the above prior to explants that would result in exceeding the above stated criteria * Presence of any exclusion criterion based on the standard practice of the investigational site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30-day patient survival following transplantation with the originally transplanted heart and no mechanical circulatory assist device at day 30 | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of all cardiac graft-related serious adverse events | 30 days |
| Incidence of biopsy proven ISHLT grade 2R or 3R acute rejection on any of the surveillance endomyocardial biopsies or clinically symptomatic rejection requiring augmentation of immunosuppressive therapy during the 30 day follow up | 30 day |
| Length of ICU stay | 30 day |
Countries
France, Italy, United Kingdom, United States
Outcome results
None listed