Randomized Study of Organ Care System Cardiac for Preservation of Donated Hearts for Eventual Transplantation

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Multicenter, Randomized, Clinical Investigation of TransMedics Organ Care System (OCS) for Cardiac Use

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Organ Care System
* Device: Cold Cardioplegia Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Organ Care System<br> | Device: Organ Care System<br>* 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.<br>* Other names: OCS;|
| Active Comparator: Cold cardioplegia solution<br> | Device: Cold Cardioplegia Solution<br>* This is the standard of care solutions used to arrest and preserve the donated heart during transport until arrival at recipient hospital<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Transplant, Warm Perfusion, Organ Care, Resting Mode