OCS Heart Perfusion Post-Approval Registry

OCS Heart Perfusion (OHP) 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Transplant
• Intervention / Treatment: Device: OCS Heart System

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 Type: Observational
• Enrollment (Estimated): 350

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai
    • Palo Alto, California, United States, 94304
      • Stanford University
    • San Francisco, California, United States, 94143
      • University of California San Francisco
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medicine
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University of Kentucky
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • University of Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center/ New York Presbyterian hospital
    • The Bronx, New York, United States, 10467
      • Montefiore
    • Valhalla, New York, United States, 10595
      • Westchester Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75230
      • Medical City Dallas
    • Dallas, Texas, United States, 75226
      • Baylor Scott and White
    • San Antonio, Texas, United States, 78229
      • Methodist Hospital
  • Washington
    • Seattle, Washington, United States, 98105
      • University of Washington Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert & the Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants will be adult primary heart transplant potential recipients on the waiting list for heart transplantation at the participating Registry centers.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OCS DBD Heart Primary Analysis Population; 200 adult primary heart transplant recipients of OCS perfused DBD donor hearts that meet the FDA-approved indication for use except for the following recipient exclusion criteria: Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or; On renal dialysis at time of transplant	Device: OCS Heart System; 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.
OCS DCD Heart Primary Analysis Population; 150 adult primary heart transplant recipients of OCS perfused DCD donor hearts that meet the FDA-approved indication for use except for the following recipient exclusion criteria: Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or; On renal dialysis at time of transplant; Transplanted with DCD heart with 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).	Device: OCS Heart System; 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.
Other OCS Heart Analysis Population; Any/all other recipients of OCS Heart perfused donor hearts outside of the DBD and DCD indications above will be collected in the respective arm of this registry until the enrollment of the PAP of that arm is completed (200 for DBD and 150 for DCD).	Device: OCS Heart System; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Survival	Patient survival at one-year post-heart transplant.	One year post-heart transplant

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint	Heart graft survival at 6 months post-heart transplant.	6 months post-heart transplant
Long Term Patient Survival	K-M Patient survival at 1, 2, 3, 4 and 5 years post-transplant	5 years post-heart transplant
Long Term Graft Survival	K-M Graft survival at 6mo, 1, 2, 3, 4 and 5 years post-transplant	5 years post-heart transplant

Collaborators and Investigators

• Sponsor: TransMedics

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2021
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: September 8, 2021
• First Submitted That Met QC Criteria: September 8, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Estimated): October 30, 2025
• Last Update Submitted That Met QC Criteria: October 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: OCSHEART-01-ClinPAS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes