Improving donor heart preservation with the OCS Heart System
Enhancing Heart Allograft Function With the OCS Heart System (ENHANCE) Trial
This study will test whether the OCS Heart System with a new preservation solution and a functional enhancer helps donor hearts—including DCD and higher‑risk DBD hearts—stay healthier and improve transplant outcomes compared with standard cold storage.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 655 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | TransMedics Industry-sponsored |
| Locations | 8 sites (San Francisco, California and 7 other locations) |
| Trial ID | NCT07145515 on ClinicalTrials.gov |
What this trial studies
This interventional, multicenter trial compares the TransMedics OCS Heart platform using a novel OCS Solution plus OCS Functional Enhancer (OFE) against standard Static Cold Storage (SCS) for donor hearts. Part A enrolls DCD donor hearts and DBD hearts initially deemed unsuitable for cold storage to support approval for those indications, while Part B compares OCS versus SCS in DBD hearts currently managed with cold storage to potentially demonstrate superiority. Key donor criteria include DCD functional warm ischemic time ≤30 minutes and DBD hearts with expected cross clamp ≥4 hours or organ‑quality concerns (eg, age ≥40 or LVEF ≤50%), with exclusion for moderate‑to‑severe aortic incompetence. The sponsor is TransMedics and participating sites include UCSF, Tampa General Hospital, and Massachusetts General Hospital, with safety and effectiveness endpoints intended to support FDA approval.
Who should consider this trial
Good fit: Ideal candidates are adults listed for heart transplantation who may receive DCD donor hearts or higher‑risk DBD donor hearts preserved with the OCS Heart System at a participating center.
Not a fit: Patients not listed for transplant, pediatric recipients, or those receiving standard low‑risk DBD hearts managed with conventional cold storage may not gain direct benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could increase the number of usable donor hearts and reduce ischemic injury, improving early graft function and longer‑term transplant outcomes.
How similar studies have performed: Previous clinical work with the TransMedics OCS platform has demonstrated feasibility and favorable preservation in selected settings, though use of the new OCS Solution and OFE across broader DBD and DCD populations is a further, partly novel step.
Eligibility criteria
Show full inclusion / exclusion criteria
Part A - DCD Donor Hearts \& DBD Donor Hearts Initially Deemed Unsuitable for Cold Storage (Current Approved Indications): Donor Inclusion Criteria * Donor hearts are deemed clinically acceptable for transplantation after physical examination of the donor hearts in the donor chest and/or on the back table in the donor operating room. * All DCD donors eligible for functional warm ischemic time criteria ≤ 30 minutes. WIT defined as time from when mean systolic blood pressure (SBP) is \<50mmHg (sustained for at least 5 minutes) to aortic cross clamp and administration of old cardioplegia in the donor. * DBD donor hearts with an expected cross clamp of ≥ 4 hours * DBD donor hearts with any of the following organ quality concerns, regardless of cross clamp time: * Donor age ≥ 40 years old * Unknown downtime * Insignificant CAD * LVEF ≤ 50% Donor Exclusion • Moderate to severe aortic incompetence Part B - DBD Donor Hearts Currently Used with Cold Storage (New Indication): Donor Inclusion Criteria * Donor hearts are deemed clinically acceptable for transplantation after physical examination of the donor hearts in the donor chest and/or on the back table in the donor operating room. * Eligible for randomization to OCS or SCS treatment arms. * DBD donor hearts with an expected cross clamp time of \< 4 hours. Donor Exclusion * Moderate to severe aortic incompetence * DBD donor with any of the following organ quality concerns: * Donor age ≥ 40 years old * Unknown downtime * Insignificant CAD * LVEF ≤ 50% Recipient Eligibility Criteria (for Part A and B Cohorts) Inclusion * Signed informed consent document and authorization to use and disclose protected health information * Heart transplant candidate * Age ≥ 18 years old Exclusion • Participant in any other interventional clinical or investigational trials/programs that may confound the outcomes of this trial
Where this trial is running
San Francisco, California and 7 other locations
- University of California San Francisco — San Francisco, California, United States (Recruiting)
- Tampa General Hospital — Tampa, Florida, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Mount Sinai — New York, New York, United States (Recruiting)
- Columbia University Irving Medical Center/ New York Presbyterian Hospital — New York, New York, United States (Not_yet_recruiting)
- Westchester Medical Center — Valhalla, New York, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
- Baylor Scott and White — Dallas, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Raicca Haqqi
- Email: rhaqqi@transmedics.com
- Phone: 978-809-0620
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.