Heart TransplantNCT03831048
Donors After Circulatory Death Heart Trial
A study testing OCS Heart System and Cold Storage in people with Heart Transplant, run by TransMedics at 25 sites in United States.
Trial summary
To evaluate the effectiveness of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplant
- What is being tested?
- OCS Heart System and Cold Storage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 25 sitesUnited States
- Study dates
- 26 Nov 2019to 28 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Donor Inclusion
- Maastricht Category III DCD donor, defined as expected death after the withdrawal of life- supportive therapy (WLST)
- Donor age 18-49 years old inclusive
- Warm ischemic time (WIT) ≤ 30 mins, with warm ischemic time defined as: Time from when mean systolic blood pressure (SBP) is < 50 mmHg or peripheral saturation < 70% to aortic cross-clamp and administration of cold cardioplegia in the donor.
Donor Exclusion
- Previous cardiac surgery
- Known coronary artery disease
- Cardiogenic shock or myocardial infarction, or
- Sustained terminal ejection fraction (EF) of ≤ 50%, or
- Significant valve disease except for competent bicuspid aortic valve
Recipient Inclusion
- Primary heart transplant candidates
- Age ≥ 18 years old
- Signed: (1) written informed consent document; (2) authorization to use and disclose protected health information; and (3) consent to TransMedics' use of recipients' United Network for Organ Sharing (UNOS)/Organ Procurement and Transplantation Network (OPTN) data and recipients' Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) data.
Recipient Exclusion
- Prior solid organ or bone marrow transplant
- Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
- Multi-organ transplant
- Investigator unwilling to randomize to either arm.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Emory University Hospital
Atlanta, Georgia, 30322
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Northwestern Medicine
Chicago, Illinois, 60611
Duke University
Durham, North Carolina, 27710
St. Vincent Cardiovascular Research Institute
Indianapolis, Indiana, 46260
Mayo Clinic Florida
Jacksonville, Florida, 32224
University of California San Diago
La Jolla, California, 92037
Cedars Sinai
Los Angeles, California, 90048
University of Wisconsin
Madison, Wisconsin, 53792
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
University of Minnesota
Minneapolis, Minnesota, 55414
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Yale New Haven Hospital
New Haven, Connecticut, 06510
Nyph/Cumc
New York, New York, 10032
Sentara
Norfolk, Virginia, 23502
University of Nebraska Medical Center
Omaha, Nebraska, 68198
AdventHealth
Orlando, Florida, 32804
Stanford University
Palo Alto, California, 94304
Virgina Commonwealth University
Richmond, Virginia, 23298
Tampa General Hospital
Tampa, Florida, 33606
Montefiore
The Bronx, New York, 10467
Westchester Medical Center
Valhalla, New York, 10595
About this study
Official title: Clinical Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts From Donors After Circulatory Death (DCD Heart Trial)
To evaluate the effectiveness of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.
Read the detailed description
A prospective, randomized and concurrent controlled, non-inferiority pivotal trial in which subjects who receive a DCD donor heart transplant will be compared to subjects who receive a standard criteria donor heart transplant (Standard of Care 1 [SOC1] and Standard of Care 2 [SOC2] - from both randomized and concurrent control groups), adjusting for differences in risk factors.
- Conditions
- Heart Transplant
- Being tested
- OCS Heart System, Cold Storage
- Keywords
- Heart preservation, Beating heart transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCS Heart SystemDevice
Preserving and assessing donor after circulatory death hearts for transplant
Cold StorageOther
Active comparator intervention
| Study group | Role | What they receive |
|---|---|---|
| DCD Heart Possible | Experimental | Not described Receives: Device: OCS Heart System |
| Standard of Care Heart Only | Active comparator | Not described Receives: Other: Cold Storage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Patient survival 6 months post-transplant
Measured: 6 months
Secondary outcomes (1)
Utilization Rate
Utilization Rate, defined as the number of eligible DCD donor hearts that met the warm ischemic time limit above and were instrumented on the OCS Heart System that meet the acceptance criteria for transplantation after OCS Heart preservation divided by the total number of eligible DCD donor hearts that met the warm ischemic time limit above and were instrumented on the OCS Heart System.
Measured: Within 24 hours post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start26 Nov 2019
- Primary completion1 Apr 2021
- Study completion28 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart TransplantStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- TransMedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831048
- Sponsor's protocol ID
- OCS-CAR-03202019
- Status last verified
- Dec 2022
- First submitted
- 22 Jan 2019
- Last updated
- 7 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Merani S, Urban M, Westphal SG, Dong J, Miles CD, Maskin A, Hoffman A, Langnas AN. Improved Early Post-Transplant Outcomes and Organ Use in Kidney Transplant Using Normothermic Regional Perfusion for Donation after Circulatory Death: National Experience in the US. J Am Coll Surg. 2024 Jan 1;238(1):107-118. doi: 10.1097/XCS.0000000000000880. Epub 2023 Sep 29.
PubMed 37772721Schroder JN, Patel CB, DeVore AD, Bryner BS, Casalinova S, Shah A, Smith JW, Fiedler AG, Daneshmand M, Silvestry S, Geirsson A, Pretorius V, Joyce DL, Um JY, Esmailian F, Takeda K, Mudy K, Shudo Y, Salerno CT, Pham SM, Goldstein DJ, Philpott J, Dunning J, Lozonschi L, Couper GS, Mallidi HR, Givertz MM, Pham DT, Shaffer AW, Kai M, Quader MA, Absi T, Attia TS, Shukrallah B, Sun BC, Farr M, Mehra MR, Madsen JC, Milano CA, D'Alessandro DA. Transplantation Outcomes with Donor Hearts after Circulatory Death. N Engl J Med. 2023 Jun 8;388(23):2121-2131. doi: 10.1056/NEJMoa2212438.
PubMed 37285526Shudo Y, Benjamin-Addy R, Koyano TK, Hiesinger W, MacArthur JW, Woo YJ. Donors after circulatory death heart trial. Future Cardiol. 2021 Jan;17(1):11-17. doi: 10.2217/fca-2020-0070. Epub 2020 Jul 6.
PubMed 32628044
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts From Donors After Circulatory Death (DCD Heart Trial)
- ClinicalTrials.gov ID
- NCT03831048
- Acronym / sponsor ID
- OCS-CAR-03202019
- Conditions
- Heart Transplant
- Keywords
- Heart preservation, Beating heart transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- TransMedicsIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 28 Sep 2021 (actual)
- First posted
- 5 Feb 2019 (actual)
- Results
- Posted 7 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effectiveness of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.
Detailed description
A prospective, randomized and concurrent controlled, non-inferiority pivotal trial in which subjects who receive a DCD donor heart transplant will be compared to subjects who receive a standard criteria donor heart transplant (Standard of Care 1 [SOC1] and Standard of Care 2 [SOC2] - from both randomized and concurrent control groups), adjusting for differences in risk factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCD Heart Possible | Experimental | Device: OCS Heart System |
| Standard of Care Heart Only | Active comparator | Other: Cold Storage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| OCS Heart SystemPreserving and assessing donor after circulatory death hearts for transplant | Device | DCD Heart Possible |
| Cold StorageActive comparator intervention | Other | Standard of Care Heart Only |
Primary outcome
Survival
Time frame: 6 months
Patient survival 6 months post-transplant
1 secondary outcome
Utilization Rate
Time frame: Within 24 hours post-transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37772721Merani S, Urban M, Westphal SG, Dong J, Miles CD, Maskin A, Hoffman A, Langnas AN. Improved Early Post-Transplant Outcomes and Organ Use in Kidney Transplant Using Normothermic Regional Perfusion for Donation after Circulatory Death: National Experience in the US. J Am Coll Surg. 2024 Jan 1;238(1):107-118. doi: 10.1097/XCS.0000000000000880. Epub 2023 Sep 29.
- Derived from this study: PubMed 37285526Schroder JN, Patel CB, DeVore AD, Bryner BS, Casalinova S, Shah A, Smith JW, Fiedler AG, Daneshmand M, Silvestry S, Geirsson A, Pretorius V, Joyce DL, Um JY, Esmailian F, Takeda K, Mudy K, Shudo Y, Salerno CT, Pham SM, Goldstein DJ, Philpott J, Dunning J, Lozonschi L, Couper GS, Mallidi HR, Givertz MM, Pham DT, Shaffer AW, Kai M, Quader MA, Absi T, Attia TS, Shukrallah B, Sun BC, Farr M, Mehra MR, Madsen JC, Milano CA, D'Alessandro DA. Transplantation Outcomes with Donor Hearts after Circulatory Death. N Engl J Med. 2023 Jun 8;388(23):2121-2131. doi: 10.1056/NEJMoa2212438.
- Derived from this study: PubMed 32628044Shudo Y, Benjamin-Addy R, Koyano TK, Hiesinger W, MacArthur JW, Woo YJ. Donors after circulatory death heart trial. Future Cardiol. 2021 Jan;17(1):11-17. doi: 10.2217/fca-2020-0070. Epub 2020 Jul 6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCS Heart System and Cold Storage in people with Heart Transplant, run by TransMedics at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. 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?
Yes. Results are posted in the registry (first posted 7 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Survival (time frame: 6 months). 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 NCT03831048, which also lists 3 linked publications.
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 7 May 2024.