Enhancing Heart Allograft Function With the OCS Heart System Trial
Public ClinicalTrials.gov record NCT07145515. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Enhancing Heart Allograft Function With the OCS Heart System (ENHANCE) Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT07145515
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 655 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2026 (Estimated)
- Primary completion
- Jan 30, 2027 (Estimated)
- Completion
- Jul 30, 2027 (Estimated)
- Last update posted
- Jan 12, 2026
2026 – 2027
United States locations
- U.S. sites
- 8
- U.S. states
- 6
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | Recruiting |
| Tampa General Hospital | Tampa | Florida | 33606 | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Recruiting |
| Mount Sinai | New York | New York | 10029 | Recruiting |
| Columbia University Irving Medical Center/ New York Presbyterian Hospital | New York | New York | 10032 | Not yet recruiting |
| Westchester Medical Center | Valhalla | New York | 10595 | Recruiting |
| Duke University | Durham | North Carolina | 27710 | Recruiting |
| Baylor Scott and White | Dallas | Texas | 75226 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07145515, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 12, 2026 · Synced Oct 15, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07145515 live on ClinicalTrials.gov.