Registry for heart transplant outcomes using OCS Heart System
US National OCS Heart Perfusion (OHP) Registry
TransMedics · NCT05915299
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 |
|---|---|
| Enrollment | 100000 (estimated) |
| Sex | All |
| Sponsor | TransMedics (industry) |
| Locations | 37 sites (Phoenix, Arizona and 36 other locations) |
| Trial ID | NCT05915299 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this registry are heart transplant recipients who have received a donor heart preserved with the OCS Heart System.
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.
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 performed: While this registry is focused on a specific device, similar observational studies have shown success in documenting post-transplant outcomes and improving clinical practices.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * N/A Exclusion Criteria: * N/A
Where this trial is running
Phoenix, Arizona and 36 other locations
- 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)
- 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
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.
Conditions: Heart Transplant