TransplantNCT05047068
OCS Heart Perfusion Post-Approval Registry
An observational study of Transplant, run by TransMedics at 27 sites in United States.
Trial summary
The objective of this post-approval registry is to provide additional real-world evidence of the performance of the OCS Heart System to preserve DBD and DCD donor hearts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant
- What is being tested?
- OCS Heart System
- Type of treatment
- Medical device
- How many people
- 350 participants
- Where
- 27 sitesUnited States
- Study dates
- 13 Sep 2021to Dec 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Participants will be adult primary heart transplant potential recipients on the waiting list for heart transplantation at the participating Registry centers.
Who may be able to join
- Adult primary heart transplant recipients of DBD or DCD donor hearts perfused on the OCS Heart System.
- Recipient Exclusion Criteria:
- Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or
- On renal dialysis at time of transplant.
- Donor Exclusion Criteria (for DCD Donor Hearts only):
- Warm ischemic time > 30 minutes (warm ischemic time is 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).
Who cannot join
None listed.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
University of Michigan
Ann Arbor, Michigan, 48109
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
Baylor Scott and White
Dallas, Texas, 75226
Medical City Dallas
Dallas, Texas, 75230
Duke University
Durham, North Carolina, 27710
Mayo Clinic Florida
Jacksonville, Florida, 32224
University of Kentucky
Lexington, Kentucky, 40506
Cedars Sinai
Los Angeles, California, 90048
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
Columbia University Irving Medical Center/ New York Presbyterian Hospital
New York, New York, 10032
Stanford University
Palo Alto, California, 94304
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Methodist Hospital
San Antonio, Texas, 78229
University of California San Francisco
San Francisco, California, 94143
University of Washington Medical Center
Seattle, Washington, 98105
Tampa General Hospital
Tampa, Florida, 33606
Montefiore
The Bronx, New York, 10467
Westchester Medical Center
Valhalla, New York, 10595
About this study
Official title: OCS Heart Perfusion (OHP) Post-Approval Registry
The objective of this post-approval registry is to provide additional real-world evidence of the performance of the OCS Heart System to preserve DBD and DCD donor hearts.
Read the detailed description
Multi-center, observational post-approval registry to:
- compare patient and graft survival of adult primary heart transplant recipients receiving DBD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period, and
- compare patient and graft survival of adult primary heart transplant recipients receiving DCD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period.
- Conditions
- Transplant
- Being tested
- OCS Heart System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCS Heart SystemDevice
The TransMedics® OCS Heart System is a portable system available for ex-vivo maintenance of a donor heart in a metabolically active and beating state.
The OCS Heart System's innovative technology was designed to comprehensively overcome the historical limitations of cold storage. The OCS Heart System expands the utilization of donor hearts by enabling the use of donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of cold static cardioplegic preservation.
| Study group | Role | What they receive |
|---|---|---|
| OCS DBD Heart Primary Analysis Population | 200 adult primary heart transplant recipients of OCS perfused DBD donor hearts that meet the FDA-approved indication for use except for the following recipient exclusion criteria:
* Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or
* On renal dialysis at time of transplant Receives: Device: OCS Heart System | |
| OCS DCD Heart Primary Analysis Population | 150 adult primary heart transplant recipients of OCS perfused DCD donor hearts that meet the FDA-approved indication for use except for the following recipient exclusion criteria:
* Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or
* On renal dialysis at time of transplant
* Transplanted with DCD heart with warm ischemic time > 30 minutes (warm ischemic time is 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). Receives: Device: OCS Heart System | |
| Other OCS Heart Analysis Population | Any/all other recipients of OCS Heart perfused donor hearts outside of the DBD and DCD indications above will be collected in the respective arm of this registry until the enrollment of the PAP of that arm is completed (200 for DBD and 150 for DCD). Receives: Device: OCS Heart System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Survival
Patient survival at one-year post-heart transplant.
Measured: One year post-heart transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start13 Sep 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransplantStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 350 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- TransMedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047068
- Sponsor's protocol ID
- OCSHEART-01-ClinPAS
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2021
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCS Heart Perfusion (OHP) Post-Approval Registry
- ClinicalTrials.gov ID
- NCT05047068
- Acronym / sponsor ID
- OCSHEART-01-ClinPAS
- Conditions
- Transplant
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- TransMedicsIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 16 Sep 2021 (actual)
- 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 objective of this post-approval registry is to provide additional real-world evidence of the performance of the OCS Heart System to preserve DBD and DCD donor hearts.
Detailed description
Multi-center, observational post-approval registry to:
- compare patient and graft survival of adult primary heart transplant recipients receiving DBD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period, and
- compare patient and graft survival of adult primary heart transplant recipients receiving DCD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OCS DBD Heart Primary Analysis Population | – | Device: OCS Heart System200 adult primary heart transplant recipients of OCS perfused DBD donor hearts that meet the FDA-approved indication for use except for the following recipient exclusion criteria: * Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or * On renal dialysis at time of transplant |
| OCS DCD Heart Primary Analysis Population | – | Device: OCS Heart System150 adult primary heart transplant recipients of OCS perfused DCD donor hearts that meet the FDA-approved indication for use except for the following recipient exclusion criteria: * Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or * On renal dialysis at time of transplant * Transplanted with DCD heart with warm ischemic time > 30 minutes (warm ischemic time is 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). |
| Other OCS Heart Analysis Population | – | Device: OCS Heart SystemAny/all other recipients of OCS Heart perfused donor hearts outside of the DBD and DCD indications above will be collected in the respective arm of this registry until the enrollment of the PAP of that arm is completed (200 for DBD and 150 for DCD). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be adult primary heart transplant potential recipients on the waiting list for heart transplantation at the participating Registry centers.
Key inclusion criteria (6 listed)
- Adult primary heart transplant recipients of DBD or DCD donor hearts perfused on the OCS Heart System.
- Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or
- On renal dialysis at time of transplant.
- Warm ischemic time > 30 minutes (warm ischemic time is 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).
Key exclusion criteria (0 listed)
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 SystemThe TransMedics® OCS Heart System is a portable system available for ex-vivo maintenance of a donor heart in a metabolically active and beating state. The OCS Heart System's innovative technology was designed to comprehensively overcome the historical limitations of cold storage. The OCS Heart System expands the utilization of donor hearts by enabling the use of donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of cold static cardioplegic preservation. | Device | OCS DBD Heart Primary Analysis Population, OCS DCD Heart Primary Analysis Population, Other OCS Heart Analysis Population |
Primary outcome
Patient Survival
Time frame: One year post-heart transplant
Patient survival at one-year post-heart transplant.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
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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.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplant, run by TransMedics at 27 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?
The sponsor lists 6 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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?
This study is still under way. Results are not available in the source record yet.
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?
Patient Survival (time frame: One year post-heart transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2025.