US National OCS Heart Perfusion (OHP) Registry

NCT05915299 · tracked via the Priya Life Science USA tracker

Sponsor

TransMedics

Phase

Observational

Started

2023-08-25

Last updated

2025-10-30

Condition(s) studied

Heart Transplant

Investigational drug(s) / intervention(s)

OCS Heart

OCS Heart: The TransMedics® Organ Care System (OCS) Heart System is an FDA approved portable extracorporeal heart perfusion and monitoring system. 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

This Registry is a sponsor initiated, multi-center, observational post-approval registry with independent academic oversight.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria: * N/A Exclusion Criteria: * N/A

Primary outcome measure(s)

Recipients' patient and graft survival — Up to 5 years post-transplant
Recipients' patient and graft survival rates will be the primary clinical outcomes measures for all OCS Heart transplanted recipients compared to recipients receiving heart transplants using non-OCS preservation methods (cold static storage or other perfusion devices or a combination of both). This data will be obtained directly from UNOS/OPTN database.

Trial sites (37)

Facility	City	Region	Status
Banner University Medical Center Phoenix	Phoenix	Arizona	Recruiting
University of California San Diego	La Jolla	California	Recruiting
Lucile Packard Children's Hospital Stanford	Palo Alto	California	Recruiting
Stanford University	Palo Alto	California	Recruiting
University of California San Francisco	San Francisco	California	Recruiting
Boulder	Boulder	Colorado	Recruiting
Yale New Haven Hospital	New Haven	Connecticut	Recruiting
Mayo Clinic Florida	Jacksonville	Florida	Recruiting
Tampa General Hospital	Tampa	Florida	Recruiting
Emory University Hospital	Atlanta	Georgia	Recruiting
University of Chicago	Chicago	Illinois	Recruiting
University of Kentucky	Lexington	Kentucky	Recruiting
Tufts Medical Center	Boston	Massachusetts	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	Recruiting
Beth Israel Deaconess Medical Center	Boston	Massachusetts	Recruiting
University of Michigan	Ann Arbor	Michigan	Recruiting
Henry Ford	Detroit	Michigan	Recruiting
Minneapolis Heart Institute	Minneapolis	Minnesota	Recruiting
University of Minnesota	Minneapolis	Minnesota	Recruiting
Mayo Clinic Rochester	Rochester	Minnesota	Recruiting
Mount Sinai	New York	New York	Recruiting
Columbia University Irving Medical Center/ New York Presbyterian Hospital	New York	New York	Recruiting
Montefiore	The Bronx	New York	Recruiting
Westchester Medical Center	Valhalla	New York	Recruiting
University of North Carolina	Chapel Hill	North Carolina	Recruiting
Atrium Health	Charlotte	North Carolina	Recruiting
Duke University	Durham	North Carolina	Recruiting
The Christ Hospital	Cincinnati	Ohio	Recruiting
University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	Recruiting
Medical University of South Carolina	Charleston	South Carolina	Recruiting
Baylor Scott and White	Dallas	Texas	Recruiting
University of Texas Southwestern	Dallas	Texas	Recruiting
University of Utah	Salt Lake City	Utah	Recruiting
Virginia Commonwealth University Health	Richmond	Virginia	Recruiting
University of Washington Medical Center	Seattle	Washington	Recruiting
Aurora St Luke's Medical Center	Milwaukee	Wisconsin	Recruiting
Froedtert & the Medical College of Wisconsin	Milwaukee	Wisconsin	Recruiting

More TransMedics trials in the USA

US National OCS Liver Perfusion (OLP) Registry Recruiting

US National TOP Registry Recruiting

OCS Heart Perfusion Post-Approval Registry Active, not recruiting

OCS DCD Heart + CAP Continued Follow-Up Active, not recruiting

OCS Liver Perfusion (OLP) Post-Approval Registry Active, not recruiting

Other trials for the same condition

XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP) Recruiting

OCS DCD Heart + CAP Continued Follow-Up Active, not recruiting

Enhancing Heart Allograft Function With the OCS Heart System Trial 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 NCT05915299 on ClinicalTrials.gov ↗ ← All trials in the USA