Randomized Study of Organ Care System Cardiac for Preservation of Donated Hearts for Eventual Transplantation (PROCEEDII)
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ClinicalTrials.gov Identifier: NCT00855712 |
Recruitment Status :
Completed
First Posted : March 4, 2009
Last Update Posted : September 12, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Failure | Device: Organ Care System Device: Cold Cardioplegia Solution | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 128 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Prospective, Multicenter, Randomized, Clinical Investigation of TransMedics Organ Care System (OCS) for Cardiac Use |
Study Start Date : | March 2009 |
Actual Primary Completion Date : | October 2013 |
Actual Study Completion Date : | November 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Organ Care System |
Device: Organ 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.
Other Name: OCS |
Active Comparator: Cold cardioplegia solution |
Device: Cold Cardioplegia Solution
This is the standard of care solutions used to arrest and preserve the donated heart during transport until arrival at recipient hospital |
- 30-day patient survival following transplantation with the originally transplanted heart and no mechanical circulatory assist device at day 30 [ Time Frame: 30 days ]
- Incidence of all cardiac graft-related serious adverse events [ Time Frame: 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 [ Time Frame: 30 day ]
- Length of ICU stay [ Time Frame: 30 day ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855712
United States, California | |
UCLA Medical Center | |
Los Angeles, California, United States, 90095 | |
Cedars-Sinai Medical Center | |
Los Angeles, California, United States, 90211 | |
United States, Indiana | |
Indiana University | |
Indianapolis, Indiana, United States, 46202 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
United States, New Jersey | |
Newark Beth Israel Medical Center | |
Newark, New Jersey, United States, 07112 | |
United States, New York | |
Columbia University Medical Center | |
New York, New York, United States, 10032 | |
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 | |
France | |
Hospitalier Pitie-Salpetriere | |
Paris, France, 75013 | |
Italy | |
Azienda Ospedaliera S. Maria della Misericordia | |
Udine, Italy, 33100 | |
United Kingdom | |
Papworth Hospital | |
Cambridge, United Kingdom, CB23 3RE | |
Harefield Hospital | |
London Borough Of Hillingdon, United Kingdom |
Study Chair: | Abbas Ardehali, MD | University of California, Los Angeles |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | TransMedics |
ClinicalTrials.gov Identifier: | NCT00855712 History of Changes |
Other Study ID Numbers: |
CAR-05-2008 |
First Posted: | March 4, 2009 Key Record Dates |
Last Update Posted: | September 12, 2018 |
Last Verified: | May 2015 |
Keywords provided by TransMedics:
Heart Failure Transplant Warm Perfusion Organ Care Resting Mode |
Additional relevant MeSH terms:
Heart Failure Heart Diseases Cardiovascular Diseases Pharmaceutical Solutions Cardioplegic Solutions |