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US National OCS Heart Perfusion (OHP) Registry

NCT05915299 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100000

Last updated 2025-10-30

No results posted yet for this study

Summary

This Registry is a sponsor initiated, multi-center, observational post-approval registry with independent academic oversight.

Conditions

  • Heart Transplant

Interventions

DEVICE

OCS Heart

The TransMedics® Organ Care System (OCS) Heart System is an FDA approved portable extracorporeal heart perfusion and monitoring system. The OCS Heart System's innovative technology was designed to comprehensively overcome the historical limitations of cold storage. The OCS Heart System expands the utilization of donor hearts by enabling the use of donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of cold static cardioplegic preservation.

Sponsors & Collaborators

  • TransMedics

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-25
Primary Completion
2029-08-31
Completion
2033-08-31
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 NCT05915299 on ClinicalTrials.gov