Registry for heart transplant outcomes using OCS Heart System
Official title: US National OCS Heart Perfusion (OHP) Registry
Run by TransMedics · NCT05915299 · Data updated 2026-11-12
This study tracks how well the OCS Heart System works for preserving donor hearts in heart transplant patients over five years to see if it helps them do better after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 100000 (estimated) |
| Sponsor | TransMedics Industry-sponsored |
| Locations | 37 sites (Phoenix, Arizona and 36 other locations) |
| Status | Recruiting |
| Started | August 25, 2023 |
| Main results expected | August 31, 2029 |
| Study ends | August 31, 2033 |
| Registry record updated | October 30, 2025 |
| Trial ID | NCT05915299 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this registry are heart transplant recipients who have received a donor heart preserved with the OCS Heart System.
✕Probably not a fit
Patients who do not receive a heart transplant or those who receive a heart not preserved with the OCS Heart System may not benefit from this registry.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The US National OCS Heart Perfusion Registry is an observational registry aimed at collecting data on the clinical outcomes of heart transplant recipients who receive donor hearts preserved with the OCS Heart System. This multi-center initiative will follow patients for up to five years post-transplant to assess the performance of the OCS Heart device in real-world settings after its FDA approval. The registry will provide valuable insights into the effectiveness and safety of this preservation method in heart transplantation.
Why it matters
Potential benefit: If successful, this registry could enhance understanding of heart transplant outcomes and improve patient care through better preservation techniques.
How similar studies have gone: While this registry is focused on a specific device, similar observational studies have shown success in documenting post-transplant outcomes and improving clinical practices.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * N/A Exclusion Criteria: * N/A
Where it's running
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Banner University Medical Center Phoenix
Phoenix, Arizona, United States Recruiting -
University of California San Diego
La Jolla, California, United States Recruiting -
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States Recruiting -
Stanford University
Palo Alto, California, United States Recruiting -
University of California San Francisco
San Francisco, California, United States Recruiting -
Boulder
Boulder, Colorado, United States Recruiting
Show 31 more locations
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Yale New Haven Hospital
New Haven, Connecticut, United States Recruiting -
Mayo Clinic Florida
Jacksonville, Florida, United States Recruiting -
Tampa General Hospital
Tampa, Florida, United States Recruiting -
Emory University Hospital
Atlanta, Georgia, United States Recruiting -
University of Chicago
Chicago, Illinois, United States Recruiting -
University of Kentucky
Lexington, Kentucky, United States Recruiting -
Tufts Medical Center
Boston, Massachusetts, United States Recruiting -
Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting -
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States Recruiting -
University of Michigan
Ann Arbor, Michigan, United States Recruiting -
Henry Ford
Detroit, Michigan, United States Recruiting -
Minneapolis Heart Institute
Minneapolis, Minnesota, United States Recruiting -
University of Minnesota
Minneapolis, Minnesota, United States Recruiting -
Mayo Clinic Rochester
Rochester, Minnesota, 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 Recruiting -
Montefiore
The Bronx, New York, United States Recruiting -
Westchester Medical Center
Valhalla, New York, United States Recruiting -
University of North Carolina
Chapel Hill, North Carolina, United States Recruiting -
Atrium Health
Charlotte, North Carolina, United States Recruiting -
Duke University
Durham, North Carolina, United States Recruiting -
The Christ Hospital
Cincinnati, Ohio, United States Recruiting -
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States Recruiting -
Medical University of South Carolina
Charleston, South Carolina, United States Recruiting -
Baylor Scott and White
Dallas, Texas, United States Recruiting -
University of Texas Southwestern
Dallas, Texas, United States Recruiting -
University of Utah
Salt Lake City, Utah, United States Recruiting -
Virginia Commonwealth University Health
Richmond, Virginia, United States Recruiting -
University of Washington Medical Center
Seattle, Washington, United States Recruiting -
Aurora St Luke's Medical Center
Milwaukee, Wisconsin, United States Recruiting -
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States Recruiting
Study contacts
- Study coordinator: Raicca Haqqi
- Email: rhaqqi@transmedics.com
- Phone: 9788090620
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Non-invasive test to predict early heart rejection in pediatric transplant patients
This study tests non-invasive heart tests like cardiac MRI and blood markers to see if they can detect rejection in kids after heart transplant, potentially reducing the need for invasive biopsies.
-
Non-intubated anesthesia for adult heart transplantation
This trial tests whether keeping patients breathing on their own with a supraglottic airway during heart transplantation leads to fewer complications and faster recovery compared with standard intubated anesthesia.
-
Apixaban vs Warfarin in HeartMate 3 LVAD Patients
This study tests whether apixaban can replace warfarin to prevent clots and bleeding problems in adults with an implanted HeartMate 3 LVAD for at least 3 months.
-
Improving donor heart preservation with the OCS Heart System
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.
-
XVIVO Heart Box non-ischemic preservation for transporting donor hearts.
This program tests whether the XVIVO non-ischemic heart preservation system can safely preserve extended-criteria donor hearts for adults waiting for a heart transplant.
-
Empagliflozin to protect kidney and heart health after heart transplant
This trial will test whether empagliflozin can protect kidney and heart health and improve metabolic and functional outcomes in Veterans who have had a heart transplant.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.