US National OCS Heart Perfusion (OHP) R… | Clinical Trial

Key information

Conditions

Heart Transplant

Sex eligibility

All sexes

Study type

Observational

Primary location

Banner University Medical Center Phoenix, Phoenix, Arizona, United States

About this study

The objective of this US National OHP Registry is to collect data on the post-transplant clinical outcomes of all donor hearts preserved and assessed on the OCS Heart System and to document the performance of the OCS Heart device in the real-world setting after FDA approval in the US.

The US National OHP Registry will enroll all heart transplant recipients who are transplanted with an OCS-perfused donor heart in the Registry. Patients' clinical outcomes will be followed up to five years post-transplant, loss to follow up, or death, whichever occurs first.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

N/A

Exclusion criteria

N/A

Treatment and study plan

OCS Heart

Device

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.

Primary outcomes

Recipients' patient and graft survival

Time frame: Up to 5 years post-transplant

Recipients' patient and graft survival rates will be the primary clinical outcomes measures for all OCS Heart transplanted recipients compared to recipients receiving heart transplants using non-OCS preservation methods (cold static storage or other perfusion devices or a combination of both). This data will be obtained directly from UNOS/OPTN database.

Study contacts

Contact information is provided by the study sponsor or research team.

Kausar Qidwai

CONTACT

[email protected]

Raicca Haqqi

CONTACT

[email protected]

9788090620

Sponsors and collaborators

Lead sponsor

TransMedics

Industry

Registry information

Important dates

Study start: 2023
Primary completion: 2029
Study completion: 2033
First posted: Jun 22, 2023
Registry last updated: Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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