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



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:9/14/2018
Start Date:March 2009
End Date:November 2013

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

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.


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
We found this trial at
8
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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Los Angeles, CA
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, NY
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201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
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Newark, NJ
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Paris,
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