OCS DCD Heart + CAP Continued Follow-Up

OCS DCD Heart + CAP Continued Follow-Up Post-Approval Study

The objective of this post-approval study is to evaluate long-term outcomes of patients enrolled in the OCS DCD Heart and OCS DCD Heart CAP studies.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 276

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • University of California San Diago
    • Palo Alto, California, United States, 94304
      • Stanford University
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida
    • Orlando, Florida, United States, 32803
      • AdventHealth Orlando
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medicine
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • St. Vincent Cardiovascular Research Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • University of Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • New York
    • New York, New York, United States, 10032
      • Nyph/Cumc
    • The Bronx, New York, United States, 10467
      • Montefiore
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt Medical Center
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Sentara
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of 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: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients transplanted in the OCS DCD Heart Trial and OCS DCD Heart CAP will comprise the patient population for this PAS.

Description

Inclusion Criteria:

• Patients transplanted in the OCS DCD Heart Trial and OCS DCD Heart CAP trials.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient survival	Patient survival through 5 years post-transplant	5 years post-transplant

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac related patient survival	Cardiac related patient survival through 5 years post-transplant	5 years post-transplant
Graft survival	Graft survival through 5 years post-transplant	5 years post-transplant
Patient and graft survival	Patient and graft survival through 5 years post-transplant	5 years post-transplant

Collaborators and Investigators

• Sponsor: TransMedics

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2019
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Actual): February 23, 2023

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: OCS-HEART-03-PAS

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