OCS Heart Perfusion Post-Approval Registry

Active, not recruiting

• Conditions: Transplant

• Registration Number: NCT05047068
• Lead Sponsor: TransMedics

Brief Summary

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.

Detailed Description

Multi-center, observational post-approval registry to:

1. 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

2. 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.

Study Timeline

• Study First Submitted: 2021-09-08
• Study First Submitted QC: 2021-09-08
• Study Start: 2021-09-13
• Study First Posted: 2021-09-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-10
• Primary Completion: 2025-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 350

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient Survival	One year post-heart transplant	Patient survival at one-year post-heart transplant.

Trial Locations

Locations (27)

Cedars Sinai; 🇺🇸 Los Angeles, California, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Northwestern Medicine; 🇺🇸 Chicago, Illinois, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

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