Heart FailurePROCEEDIINCT00855712
Randomized Study of Organ Care System Cardiac for Preservation of Donated Hearts for Eventual Transplantation
A study testing Organ Care System and Cold Cardioplegia Solution in people with Heart Failure, run by TransMedics at 11 sites in 4 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Organ Care System and Cold Cardioplegia Solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 11 sitesin 4 countries
- Study dates
- Mar 2009to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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)
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
United States7 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Cleveland Clinic
Cleveland, Ohio, 44195
Indiana University
Indianapolis, Indiana, 46202
UCLA Medical Center
Los Angeles, California, 90095
Cedars-Sinai Medical Center
Los Angeles, California, 90211
Columbia University Medical Center
New York, New York, 10032
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
United Kingdom2 sites
Papworth Hospital
Cambridge, CB23 3RE
Harefield Hospital
London
About this study
Official title: 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.
- Conditions
- Heart Failure
- Being tested
- Organ Care System, Cold Cardioplegia Solution
- Keywords
- Heart Failure, Transplant, Warm Perfusion, Organ Care, Resting Mode
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organ Care SystemDevice
Also called OCS
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.
Cold Cardioplegia SolutionDevice
This is the standard of care solutions used to arrest and preserve the donated heart during transport until arrival at recipient hospital
| Study group | Role | What they receive |
|---|---|---|
| Organ Care System | Experimental | Not described Receives: Device: Organ Care System |
| Cold cardioplegia solution | Active comparator | Not described Receives: Device: Cold Cardioplegia Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day patient survival following transplantation with the originally transplanted heart and no mechanical circulatory assist device at day 30
Measured: 30 days
Secondary outcomes (3)
Incidence of all cardiac graft-related serious adverse events
Measured: 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
Measured: 30 day
Length of ICU stay
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by TransMedicsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- TransMedics
- Sponsor type
- Industry (pharma, biotech, devices)
- 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 NHS Foundation Trust, Azienda Ospedaliera S. Maria della Misericordia, Royal Brompton & Harefield NHS Foundation Trust, Indiana University
- Responsible party
- Sponsor
- Investigators
- Abbas Ardehali, MD, Study chair, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855712
- Sponsor's protocol ID
- CAR-05-2008
- Acronym
- PROCEEDII
- Status last verified
- May 2015
- First submitted
- 3 Mar 2009
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25888086
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized, Clinical Investigation of TransMedics Organ Care System (OCS) for Cardiac Use
- ClinicalTrials.gov ID
- NCT00855712
- Acronym / sponsor ID
- PROCEEDII / CAR-05-2008
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Transplant, Warm Perfusion, Organ Care, Resting Mode
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- TransMedicsIndustry (pharma, biotech, devices)
- 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 NHS Foundation Trust, Azienda Ospedaliera S. Maria della Misericordia, Royal Brompton & Harefield NHS Foundation Trust, Indiana University
- Study start
- Mar 2009
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 4 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Organ Care System | Experimental | Device: Organ Care System |
| Cold cardioplegia solution | Active comparator | Device: Cold Cardioplegia Solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Organ Care SystemAlso: OCSThe 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. | Device | Organ Care System |
| Cold Cardioplegia SolutionThis is the standard of care solutions used to arrest and preserve the donated heart during transport until arrival at recipient hospital | Device | Cold cardioplegia solution |
Primary outcome
30-day patient survival following transplantation with the originally transplanted heart and no mechanical circulatory assist device at day 30
Time frame: 30 days
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Derived from this study: PubMed 25888086Ardehali 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abbas Ardehali, MD study chair
University of California, Los Angeles
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Organ Care System and Cold Cardioplegia Solution in people with Heart Failure, run by TransMedics at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, United Kingdom, France, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day patient survival following transplantation with the originally transplanted heart and no mechanical circulatory assist device at day 30 (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00855712, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.