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Enhancing Heart Allograft Function With the OCS Heart System Trial

NCT07145515 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 655

Last updated 2026-01-12

No results posted yet for this study

Summary

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.

Conditions

  • Heart Transplant

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.

Sponsors & Collaborators

  • TransMedics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2027-01-30
Completion
2027-07-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07145515 on ClinicalTrials.gov