OCS Heart Perfusion Post-Approval Registry

Last updated: April 7, 2025
Sponsor: TransMedics
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

OCS Heart System

Clinical Study ID

NCT05047068
OCSHEART-01-ClinPAS
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Recipient Exclusion Criteria:

  • Concurrent (multi-organ transplant) or previous solid organ or bone marrowtransplant; 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 whenmean systolic blood pressure (SBP) is < 50 mmHg or peripheral saturation < 70% toaortic cross-clamp and administration of cold cardioplegia in the donor).

Study Design

Total Participants: 350
Treatment Group(s): 1
Primary Treatment: OCS Heart System
Phase:
Study Start date:
September 13, 2021
Estimated Completion Date:
December 31, 2029

Study 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.

Connect with a study center

  • Cedars Sinai

    Los Angeles, California 90048
    United States

    Site Not Available

  • Stanford University

    Palo Alto, California 94304
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • Yale New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Mayo Clinic Florida

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Tampa General Hospital

    Tampa, Florida 33606
    United States

    Site Not Available

  • Emory University Hospital

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Northwestern Medicine

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40506
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Minneapolis Heart Institute

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis, Minnesota 55414
    United States

    Site Not Available

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Montefiore

    Bronx, New York 10467
    United States

    Site Not Available

  • Nyph/Cumc

    New York, New York 10032
    United States

    Site Not Available

  • Westchester Medical Center

    Valhalla, New York 10595
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27710
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Baylor Scott and White

    Dallas, Texas 75226
    United States

    Site Not Available

  • Medical City Dallas

    Dallas, Texas 75230
    United States

    Site Not Available

  • Methodist Hospital

    San Antonio, Texas 78229
    United States

    Site Not Available

  • University of Washington Medical Center

    Seattle, Washington 98105
    United States

    Site Not Available

  • Froedtert & the Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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