PROCEEDII
Prospective, Multicenter, Randomized, Clinical Investigation of TransMedics Organ Care System (OCS) for Cardiac Use
Sponsor study identifier
interventional
128
4 countries
11
Study Start
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2013
Actual (reported)Study Completion
November 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
March 3, 2009
Actual (reported)March 4, 2009
Actual (reported)October 2013
Actual (reported)November 2013
Actual (reported)30-day patient survival following transplantation with the originally transplanted heart and no mechanical circulatory assist device at day 30
30 days
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
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.
UCLA Medical Center
Los Angeles, California, 90095, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90211, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
Columbia University Medical Center
New York, New York, 10032, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ardehali A, Esmailian F, Deng M, Soltesz E, Hsich E, Naka Y, Mancini D, Camacho M, Zucker M, Leprince P, Padera R, Kobashigawa J; PROCEED II trial investigators. Ex-vivo perfusion of donor hearts for human heart transplantation (PROCEED II): a prospective, open-label, multicentre, randomised non-inferiority trial. Lancet. 2015 Jun 27;385(9987):2577-84. doi: 10.1016/S0140-6736(15)60261-6. Epub 2015 Apr 14.
Abbas Ardehali, MD
University of California, Los Angeles
128 participants (actual enrollment reported by the registry).
First Submitted
March 3, 2009
First Posted
March 4, 2009
Study Start
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
Feasibility Study of an Integrated Diagnostic System to Manage Heart Failure
This is the standard of care solutions used to arrest and preserve the donated heart during transport until arrival at recipient hospital
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Hospitalier Pitie-Salpetriere
Paris, 75013, France
Azienda Ospedaliera S. Maria della Misericordia
Udine, 33100, Italy
Papworth Hospital
Cambridge, CB23 3RE, United Kingdom
Harefield Hospital
London, United Kingdom
Primary Completion
October 2013
Actual (reported)Study Completion
November 2013
Actual (reported)Last Updated
June 9, 2020
Record last verified: 2015-05
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Source: ClinicalTrials.gov.
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