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Recruiting NCT07145515

Enhancing Heart Allograft Function With the OCS Heart System Trial

No phase Interventional Heart Transplant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: OCS Heart, Static Cold Storage (SCS).
Who it may be relevant to
Registry conditions: Heart Transplant. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Enhancing Heart Allograft Function With the OCS Heart System (ENHANCE) Trial

Overview

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.

Interventions

  • Device OCS Heart
    Preservation of donor hearts with OCS Heart System and novel OCS Solution and OCS Functional Enhancer.
  • Other Static Cold Storage (SCS)
    Preservation of donor hearts with static cold storage.

Primary outcome measures

  • Patient and graft survival [Time frame: 30-day post transplant]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 8 centers
  • University of California San Francisco — San Francisco
  • Tampa General Hospital — Tampa
  • Massachusetts General Hospital — Boston
  • Mount Sinai — New York
  • Columbia University Irving Medical Center/ New York Presbyterian Hospital — New York
  • Westchester Medical Center — Valhalla
  • Duke University — Durham
  • Baylor Scott and White — Dallas

Identifiers

NCT: NCT07145515 · OCS-HEART-031725

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗