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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by TransMedics
Sponsor:
Collaborators:
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
Azienda Ospedaliera S. Maria della Misericordia
Royal Brompton & Harefield NHS Foundation Trust
Indiana University
Information provided by (Responsible Party):
TransMedics
ClinicalTrials.gov Identifier:
NCT00855712
First received: March 3, 2009
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Heart Failure
Device: Organ Care System
Device: Cold Cardioplegia Solution
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Multicenter, Randomized, Clinical Investigation of TransMedics Organ Care System (OCS) for Cardiac Use

Resource links provided by NLM:


Further study details as provided by TransMedics:

Primary Outcome Measures:
  • 30-day patient survival following transplantation with the originally transplanted heart and no mechanical circulatory assist device at day 30 [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of all cardiac graft-related serious adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Length of ICU stay [ Time Frame: 30 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 128
Study Start Date: March 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855712

Locations
United States, California
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Abbas Ardehali, MD    310-825-5841    aardehali@mednet.ucla.edu   
Contact: Christian Eisenring, RN    310-794-9307    Ceisenring@mednet.ucla.edu   
Principal Investigator: Abbas Ardehali, MD         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90211
Contact: Fardad Esmailian, MD    310-423-3851    fardad.esmailian@cshs.org   
Contact: Maria Thottam    310-248-7136    maria.thottam@cshs.org   
Principal Investigator: Fardad Esmailian, MD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: I-wen Wang, MD       IWang@IUHealth.org   
Principal Investigator: I-wen Wang, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Joren Madsen, MD    617-643-4587    jcmadsen@partners.org   
Contact: Sandra Debronkart    617-726-2631    sdebronkart@partners.org   
Principal Investigator: Joren Madsen, MD         
United States, New Jersey
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
Contact: Margarita Camacho, MD    973-926-6938    mcamacho@sbhcs.com   
Contact: Laura Adams    973-926-8451    ladams@sbhcs.com   
Principal Investigator: Margarita Camacho, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Yoshifumi Naka, MD    212-305-0828    yn33@columbia.edu   
Contact: Lyn Goldsmith, RN    212-342-0261    lg2240@columbia.edu   
Principal Investigator: Yoshifumi Naka, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Edward Soltesz, MD    216-444-0648    edward.soltesz@gmail.com   
Contact: Barbara Gus    216-445-6552    gusb@ccf.org   
Principal Investigator: Edward Soltesz, MD         
France
Hospitalier Pitie-Salpetriere Recruiting
Paris, France, 75013
Contact: Pascal Leprince, MD    33 1 42 16 56 32    pascal.leprince@psl.aphp.fr   
Contact: Agnes Gaubert    33 6 18 04 90 33    agnes.gaubert@psl.aphp.fr   
Principal Investigator: Pascal Leprince, MD         
Italy
Azienda Ospedaliera S. Maria della Misericordia Recruiting
Udine, Italy, 33100
Contact: Ugolino Livi, MD    39 0432 552430    livi.ugo@aoud.sanita.fvg.it   
Principal Investigator: Ugolino Livi, MD         
United Kingdom
Papworth Hospital Recruiting
Cambridge, United Kingdom, CB23 3RE
Contact: Steven Tsui, MD    44 1480 364297    steven.tsui@papworth.nhs.uk   
Contact: Tanya Burns    44 1480 830541    tanya.burns@papworth.nhs.uk   
Principal Investigator: Steven Tsui, MD         
Harefield Hospital Recruiting
London Borough of Hillingdon, United Kingdom
Contact: Andre Simon, MD       a.simon@rbht.nhs.uk   
Principal Investigator: Andre Simon, MD         
Sponsors and Collaborators
TransMedics
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
Azienda Ospedaliera S. Maria della Misericordia
Royal Brompton & Harefield NHS Foundation Trust
Indiana University
Investigators
Study Chair: Abbas Ardehali, MD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: TransMedics
ClinicalTrials.gov Identifier: NCT00855712     History of Changes
Other Study ID Numbers: CAR-05-2008
Study First Received: March 3, 2009
Last Updated: July 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by TransMedics:
Heart Failure
Transplant
Warm Perfusion
Organ Care
Resting Mode

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Cardioplegic Solutions
Pharmaceutical Solutions
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014