Improving donor heart preservation with the OCS Heart System

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional, multicenter trial compares the TransMedics OCS Heart platform using a novel OCS Solution plus OCS Functional Enhancer (OFE) against standard Static Cold Storage (SCS) for donor hearts. Part A enrolls DCD donor hearts and DBD hearts initially deemed unsuitable for cold storage to support approval for those indications, while Part B compares OCS versus SCS in DBD hearts currently managed with cold storage to potentially demonstrate superiority. Key donor criteria include DCD functional warm ischemic time ≤30 minutes and DBD hearts with expected cross clamp ≥4 hours or organ‑quality concerns (eg, age ≥40 or LVEF ≤50%), with exclusion for moderate‑to‑severe aortic incompetence. The sponsor is TransMedics and participating sites include UCSF, Tampa General Hospital, and Massachusetts General Hospital, with safety and effectiveness endpoints intended to support FDA approval.

Why it matters

Who can join: the full rules

Part A - DCD Donor Hearts \& DBD Donor Hearts Initially Deemed Unsuitable for Cold Storage (Current Approved Indications):

Donor Inclusion Criteria

* Donor hearts are deemed clinically acceptable for transplantation after physical examination of the donor hearts in the donor chest and/or on the back table in the donor operating room.
* All DCD donors eligible for functional warm ischemic time criteria ≤ 30 minutes. WIT defined as time from when mean systolic blood pressure (SBP) is \<50mmHg (sustained for at least 5 minutes) to aortic cross clamp and administration of old cardioplegia in the donor.
* DBD donor hearts with an expected cross clamp of ≥ 4 hours
* DBD donor hearts with any of the following organ quality concerns, regardless of cross clamp time:

  * Donor age ≥ 40 years old
  * Unknown downtime
  * Insignificant CAD
  * LVEF ≤ 50%

Donor Exclusion • Moderate to severe aortic incompetence

Part B - DBD Donor Hearts Currently Used with Cold Storage (New Indication):

Donor Inclusion Criteria

* Donor hearts are deemed clinically acceptable for transplantation after physical examination of the donor hearts in the donor chest and/or on the back table in the donor operating room.
* Eligible for randomization to OCS or SCS treatment arms.
* DBD donor hearts with an expected cross clamp time of \< 4 hours.

Donor Exclusion

* Moderate to severe aortic incompetence
* DBD donor with any of the following organ quality concerns:

  * Donor age ≥ 40 years old
  * Unknown downtime
  * Insignificant CAD
  * LVEF ≤ 50%

Recipient Eligibility Criteria (for Part A and B Cohorts)

Inclusion

* Signed informed consent document and authorization to use and disclose protected health information
* Heart transplant candidate
* Age ≥ 18 years old

Exclusion

• Participant in any other interventional clinical or investigational trials/programs that may confound the outcomes of this trial

Where it's running

• University of California San Francisco
  San Francisco, California, United States Recruiting
• Tampa General Hospital
  Tampa, Florida, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Mount Sinai
  New York, New York, United States Recruiting
• Westchester Medical Center
  Valhalla, New York, United States Recruiting
• Duke University
  Durham, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Raicca Haqqi
• Email: rhaqqi@transmedics.com
• Phone: 978-809-0620

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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.