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Active, Not Recruiting

NCT Number: NCT05047068

OCS Heart Perfusion Post-Approval Registry

The objective of this post-approval registry is to provide additional real-world evidence of the performance of the OCS Heart System to preserve DBD and DCD donor hearts.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cedars Sinai, Los Angeles, California, United States

Loading trial locations.

About this study

Multi-center, observational post-approval registry to:

  • compare patient and graft survival of adult primary heart transplant recipients receiving DBD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period, and
  • compare patient and graft survival of adult primary heart transplant recipients receiving DCD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult primary heart transplant recipients of DBD or DCD donor hearts perfused on the OCS Heart System.

Recipient Exclusion Criteria:

  • Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or
  • On renal dialysis at time of transplant.

Donor Exclusion Criteria (for DCD Donor Hearts only):

  • Warm ischemic time > 30 minutes (warm ischemic time is defined as: Time from when mean systolic blood pressure (SBP) is < 50 mmHg or peripheral saturation < 70% to aortic cross-clamp and administration of cold cardioplegia in the donor).

Treatment and study plan

OCS Heart System

Device

The TransMedics® OCS Heart System is a portable system available for ex-vivo maintenance of a donor heart in a metabolically active and beating state.

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

  1. Patient Survival

    Time frame: One year post-heart transplant

    Patient survival at one-year post-heart transplant.

Other outcomes

  1. Safety Endpoint

    Time frame: 6 months post-heart transplant

    Heart graft survival at 6 months post-heart transplant.

  2. Long Term Patient Survival

    Time frame: 5 years post-heart transplant

    K-M Patient survival at 1, 2, 3, 4 and 5 years post-transplant

  3. Long Term Graft Survival

    Time frame: 5 years post-heart transplant

    K-M Graft survival at 6mo, 1, 2, 3, 4 and 5 years post-transplant

Sponsors and collaborators

Lead sponsor

TransMedics

Industry

Registry information

Official study title

OCS Heart Perfusion (OHP) Post-Approval Registry

Important dates

Study start
2021
Primary completion
2025
Study completion
2029
First posted
Sep 16, 2021
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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