Clinical trial Recruiting at 37 sites Observational

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 typeObservational
SexAll
Enrollment100000 (estimated)
SponsorTransMedics
Industry-sponsored
Locations37 sites (Phoenix, Arizona and 36 other locations)
StatusRecruiting
StartedAugust 25, 2023
Main results expectedAugust 31, 2029
Study endsAugust 31, 2033
Registry record updatedOctober 30, 2025
Trial IDNCT05915299 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • 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.

    Recruiting at 22 sites Vanderbilt University Medical Center · Little Rock, Arkansas and 21 other locations · NCT07770659

  • 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.

    Recruiting The First Affiliated Hospital of Guangzhou Medical University · Guangzhou, Guangdong · NCT07758894

  • 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.

    Recruiting Phase 3 Columbia University · New York, New York · NCT07471139

  • 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.

    Recruiting at 7 sites TransMedics · San Francisco, California and 7 other locations · NCT07145515

  • 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.

    Recruiting at 14 sites XVIVO Perfusion · La Jolla, California and 13 other locations · NCT06895070

  • 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.

    Recruiting Phase 4 VA Office of Research and Development · Palo Alto, California and 5 other locations · NCT06625073

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.