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Clinical Trials in the USA / NCT05047068
Active, not recruiting Observational

OCS Heart Perfusion Post-Approval Registry

NCT05047068 · tracked via the Priya Life Science USA tracker
Sponsor
TransMedics
Phase
Observational
Started
2021-09-13
Last updated
2025-10-30

Condition(s) studied

Transplant

Investigational drug(s) / intervention(s)

OCS Heart System

OCS Heart System: The TransMedics® OCS Heart System is a portable system available for ex-vivo maintenance of a donor heart in a metabolically active and beating state. The OCS Heart System's innovative technology was designed to comprehensively overcome the historical limitations of cold storage. The OCS Heart System expands the utilization of donor hearts by enabling the use of donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of cold static cardioplegic preservation.

Study summary

The objective of this post-approval registry is to provide additional real-world evidence of the performance of the OCS Heart System to preserve DBD and DCD donor hearts.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult primary heart transplant recipients of DBD or DCD donor hearts perfused on the OCS Heart System. Recipient Exclusion Criteria: * Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or * On renal dialysis at time of transplant. Donor Exclusion Criteria (for DCD Donor Hearts only): * Warm ischemic time \> 30 minutes (warm ischemic time is defined as: Time from when mean systolic blood pressure (SBP) is \< 50 mmHg or peripheral saturation \< 70% to aortic cross-clamp and administration of cold cardioplegia in the donor).

Primary outcome measure(s)

  • Patient Survival — One year post-heart transplant
    Patient survival at one-year post-heart transplant.

Trial sites (27)

FacilityCityRegionStatus
Cedars Sinai Los Angeles California
Stanford University Palo Alto California
University of California San Francisco San Francisco California
Yale New Haven Hospital New Haven Connecticut
Mayo Clinic Florida Jacksonville Florida
Tampa General Hospital Tampa Florida
Emory University Hospital Atlanta Georgia
Northwestern Medicine Chicago Illinois
University of Kentucky Lexington Kentucky
Tufts Medical Center Boston Massachusetts
Massachusetts General Hospital Boston Massachusetts
Brigham and Women's Hospital Boston Massachusetts
University of Michigan Ann Arbor Michigan
Minneapolis Heart Institute Minneapolis Minnesota
University of Minnesota Minneapolis Minnesota
Mayo Clinic Rochester Rochester Minnesota
Columbia University Irving Medical Center/ New York Presbyterian Hospital New York New York
Montefiore The Bronx New York
Westchester Medical Center Valhalla New York
Duke University Durham North Carolina
University of Pittsburgh Medical Center Pittsburgh Pennsylvania
Vanderbilt University Medical Center Nashville Tennessee
Baylor Scott and White Dallas Texas
Medical City Dallas Dallas Texas
Methodist Hospital San Antonio Texas
University of Washington Medical Center Seattle Washington
Froedtert & the Medical College of Wisconsin Milwaukee Wisconsin

More TransMedics trials in the USA

OCS DCD Heart + CAP Continued Follow-Up Active, not recruiting
US National OCS Liver Perfusion (OLP) Registry Recruiting
US National TOP Registry Recruiting
OCS Liver Perfusion (OLP) Post-Approval Registry Active, not recruiting
OCS™ Lung TOP Registry For Donor Lungs for Transplantation Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05047068 on ClinicalTrials.gov ↗ ← All trials in the USA