NCT07145515 · TransMedics
Enhancing Heart Allograft Function With the OCS Heart System Trial
(ENHANCE)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 criteria
- • 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
- San Francisco, California
- Tampa, Florida
- Boston, Massachusetts
- New York, New York
- Valhalla, New York
- Durham, North Carolina
- Dallas, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 12, 2026 · Source of record for eligibility and locations