Clinical trialNCT07145515RecruitingInterventional

Enhancing Heart Allograft Function With the OCS Heart System Trial

SponsorTransMedicsEnrollment655Heart Transplant

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This trial is designed to evaluate the safety and effectiveness of the novel OCS Solution and OCS Functional Enhancer (OFE) to support FDA approval in both DBD and DCD heart transplantation. In addition, this trial will evaluate the performance of the novel OCS Solution and OFE compared to Static Cold Storage (SCS) in DBD heart transplantation to potentially demonstrate superiority.

clinicaltrials.gov ↗

Investigators

No overall officials are registered on this study record. Site-level investigators, where published, appear with their sites below. Why? →

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

8 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of California San Francisco
San Francisco, California, United States
Liviu Klein, MD
Recruiting
Tampa General Hospital
Tampa, Florida, United States
Lucian Lozonschi, MD
Recruiting
Massachusetts General Hospital
Boston, Massachusetts, United States
David D'Alessandro, MD
Recruiting
Columbia University Irving Medical Center/ New York Presbyterian Hospital
New York, New York, United States
Koji Takeda, MD
Not, yet, recruiting
Mount Sinai
New York, New York, United States
Anelechi Anyanwu, MD
Recruiting
Westchester Medical Center
Valhalla, New York, United States
David Spielvogel, MD
Recruiting
Duke University
Durham, North Carolina, United States
Jacob Schroder, MD
Recruiting
Baylor Scott and White
Dallas, Texas, United States
Dan Meyer, MD
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Jan 2026
Primary completion: 30 Jan 2027
Completion: 30 Jul 2027
Last update posted: 12 Jan 2026
Registered enrollment: 655
Registry id: NCT07145515

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.