Heart TransplantENHANCENCT07145515
Enhancing Heart Allograft Function With the OCS Heart System Trial
A study testing OCS Heart and Static Cold Storage (SCS) in people with Heart Transplant, run by TransMedics at 8 sites in United States.
Trial summary
This trial is designed to evaluate the safety and effectiveness of the novel OCS Solution and OCS Functional Enhancer (OFE) to support FDA approval in both DBD and DCD heart 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 and Static Cold Storage (SCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 655 participants
- Where
- 8 sitesUnited States
- Study dates
- Jan 2026to 30 Jul 2027
- Phase
- Interventional
- 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
Who may be able to join
- Signed informed consent document and authorization to use and disclose protected health information
- Heart transplant candidate
- Age ≥ 18 years old
Who cannot join
- Participant in any other interventional clinical or investigational trials/programs that may confound the outcomes of this trial
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Kamila Drezek, KDREZEK@mgh.harvard.edu
David D'Alessandro, MD
- Recruiting
Baylor Scott and White
Dallas, Texas, 75226
Lesia Parker
Dan Meyer, MD
- Recruiting
Duke University
Durham, North Carolina, 27710
Sarah Casalinova, 919-613-5621, sarah.casalinova@duke.edu
Jacob Schroder, MD
- Recruiting
Mount Sinai
New York, New York, 10029
Favio Herbas, Favio.Herbas@mountsinai.org
Anelechi Anyanwu, MD
- Not yet recruiting
Columbia University Irving Medical Center/ New York Presbyterian Hospital
New York, New York, 10032
Bo Lu, bl2699@cumc.columbia.edu
Koji Takeda, MD
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Imani Dunn, Imani.Robinson@ucsf.edu
Liviu Klein, MD
- Recruiting
Tampa General Hospital
Tampa, Florida, 33606
Courtney Nicholas, 813-844-4914, courtneynicholas@tgh.org
Lucian Lozonschi, MD
- Recruiting
Westchester Medical Center
Valhalla, New York, 10595
Corazon De La Pena, 914-493-2483, Corazon.Delapena@wmchealth.org
David Spielvogel, MD
About this study
Official title: Enhancing Heart Allograft Function With the OCS Heart System (ENHANCE) Trial
This trial is designed to evaluate the safety and effectiveness of the novel OCS Solution and OCS Functional Enhancer (OFE) to support FDA approval in both DBD and DCD heart transplantation. In addition, this trial will evaluate the performance of the novel OCS Solution and OFE compared to Static Cold Storage (SCS) in DBD heart transplantation to potentially demonstrate superiority.
- Conditions
- Heart Transplant
- Being tested
- OCS Heart, Static Cold Storage (SCS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCS HeartDevice
Preservation of donor hearts with OCS Heart System and novel OCS Solution and OCS Functional Enhancer.
Static Cold Storage (SCS)Other
Preservation of donor hearts with static cold storage.
| Study group | Role | What they receive |
|---|---|---|
| Part A (OCS Heart) | Experimental | DCD Donor Hearts \& DBD Donor Hearts Initially Deemed Unsuitable for Cold Storage (Current Approved Indications) Receives: Device: OCS Heart |
| Part B (OCS Heart) | Experimental | DBD Donor Hearts Currently Used with Cold Storage Receives: Device: OCS Heart |
| Part B (SCS) | Active comparator | DBD Donor Hearts Currently Used with Cold Storage Receives: Other: Static Cold Storage (SCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient and graft survival
The primary endpoint is 30-day patient and graft survival with freedom from moderate or severe LV or RV primary graft dysfunction (PGD) in the first 24 hours post-transplant.
Measured: 30-day post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study startJan 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 655 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TransMedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145515
- Sponsor's protocol ID
- OCS-HEART-031725
- Acronym
- ENHANCE
- Status last verified
- Jan 2026
- First submitted
- 25 Aug 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Heart Allograft Function With the OCS Heart System (ENHANCE) Trial
- ClinicalTrials.gov ID
- NCT07145515
- Acronym / sponsor ID
- ENHANCE / OCS-HEART-031725
- Conditions
- Heart Transplant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 655 participants (estimated)
- Lead sponsor
- TransMedicsIndustry (pharma, biotech, devices)
- Study start
- Jan 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 28 Aug 2025 (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.
This trial is designed to evaluate the safety and effectiveness of the novel OCS Solution and OCS Functional Enhancer (OFE) to support FDA approval in both DBD and DCD heart transplantation. In addition, this trial will evaluate the performance of the novel OCS Solution and OFE compared to Static Cold Storage (SCS) in DBD heart transplantation to potentially demonstrate superiority.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A (OCS Heart) | Experimental | Device: OCS HeartDCD Donor Hearts \& DBD Donor Hearts Initially Deemed Unsuitable for Cold Storage (Current Approved Indications) |
| Part B (OCS Heart) | Experimental | Device: OCS HeartDBD Donor Hearts Currently Used with Cold Storage |
| Part B (SCS) | Active comparator | Other: Static Cold Storage (SCS)DBD Donor Hearts Currently Used with Cold Storage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed informed consent document and authorization to use and disclose protected health information
- Heart transplant candidate
- Age ≥ 18 years old
Key exclusion criteria (1 listed)
- Participant in any other interventional clinical or investigational trials/programs that may confound the outcomes of this trial
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 HeartPreservation of donor hearts with OCS Heart System and novel OCS Solution and OCS Functional Enhancer. | Device | Part A (OCS Heart), Part B (OCS Heart) |
| Static Cold Storage (SCS)Preservation of donor hearts with static cold storage. | Other | Part B (SCS) |
Primary outcome
Patient and graft survival
Time frame: 30-day post transplant
The primary endpoint is 30-day patient and graft survival with freedom from moderate or severe LV or RV primary graft dysfunction (PGD) in the first 24 hours post-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 12 Jan 2026.
- Individual participant dataSharing planned: No
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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.
8 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 and Static Cold Storage (SCS) in people with Heart Transplant, run by TransMedics at 8 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Contact Raicca Haqqi (978-809-0620, rhaqqi@transmedics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient and graft survival (time frame: 30-day post 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 12 Jan 2026.