Enhancing Heart Allograft Function With the OCS Heart System Trial (NCT07145515)
Enhancing Heart Allograft Function With the OCS Heart System (ENHANCE) Trial
🩺 Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: University of California San Francisco — San Francisco, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (8 Sites)
- University of California San Francisco — San Francisco, California
- Tampa General Hospital — Tampa, Florida
- Massachusetts General Hospital — Boston, Massachusetts
- Mount Sinai — New York, New York
- Columbia University Irving Medical Center/ New York Presbyterian Hospital — New York, New York
- Westchester Medical Center — Valhalla, New York
- Duke University — Durham, North Carolina
- Baylor Scott and White — Dallas, Texas
📞 Contact the Study Coordinator
Phone: (978) 809-0620
Email: rhaqqi@transmedics.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Heart Transplant
- OCS DCD Heart + CAP Continued Follow-Up — La Jolla, California
- XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP) — La Jolla, California
- US National OCS Heart Perfusion (OHP) Registry — Phoenix, Arizona
- Randomized Trial of SGLT2i in Heart Transplant Recipients — Palo Alto, California
- Belatacept in Heart Transplantation — Los Angeles, California
- Non-invasive Prediction of EArly Cardiac rEjection — Little Rock, Arkansas
Explore by condition: All Heart Transplant clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.