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Enhancing Heart Allograft Function With the OCS Heart System Trial

This study is looking at a new way to preserve donor hearts for transplant using the OCS Heart System, which includes a special OCS Solution and OCS Functional Enhancer. Researchers want to see if this system is safe and effective, and potentially better than the current method called Static Cold Storage (SCS). You might be able to join if you are 18 or older and are receiving a heart transplant from a donor whose heart is considered suitable for transplantation. The main goal is to see how well patients and their new hearts are doing 30 days after the transplant. The current status of this study is unclear.

Study design
This interventional study plans to enroll 655 participants. It compares the OCS Heart System to Static Cold Storage (SCS) for preserving donor hearts.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will follow up to measure patient and graft survival 30 days after the transplant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07145515

Enhancing Heart Allograft Function With the OCS Heart System Trial

Recruiting
NAAges 18+InterventionalTreatment
TransMedics
~655 participants
Updated 2026-01-12 on ClinicalTrials.gov
What's tested:OCS HeartStatic Cold Storage (SCS)

At a glance

Recruiting sites
7 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Patient and graft survival
Measured over 30-day post transplant

Conditions

Heart Transplant

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NCT07145515

Where you'd take part

This study runs at 8 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Columbia University Irving Medical Center/ New York Presbyterian Hospital

    New York, New Yorkstudy coordinator listed

    Not yet recruiting

  • Duke University

    Durham, North Carolinastudy coordinator listed

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Mount Sinai

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Tampa General Hospital

    Tampa, Floridastudy coordinator listed

    Recruiting

  • University of California San Francisco

    San Francisco, Californiastudy coordinator listed

    Recruiting

  • Westchester Medical Center

    Valhalla, New Yorkstudy coordinator listed

    Recruiting

  • Baylor Scott and White

    Dallas, Texasno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Raicca Haqqi
[email protected]
978-809-0620
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

What this trial measures

  • Patient and graft survival30-day post transplant

    The primary endpoint is 30-day patient and graft survival with freedom from moderate or severe LV or RV primary graft dysfunction (PGD) in the first 24 hours post-transplant.