Donors After Circulatory Death Heart Trial

Clinical Trial to Evaluate the Safety and Effectiveness of The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts From Donors After Circulatory Death (DCD Heart Trial)

To evaluate the effectiveness of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.

Study Overview

• Status: Completed
• Conditions: Heart Transplant
• Intervention / Treatment: Device: OCS Heart System; Other: Cold Storage

Detailed Description

A prospective, randomized and concurrent controlled, non-inferiority pivotal trial in which subjects who receive a DCD donor heart transplant will be compared to subjects who receive a standard criteria donor heart transplant (Standard of Care 1 [SOC1] and Standard of Care 2 [SOC2] - from both randomized and concurrent control groups), adjusting for differences in risk factors.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • University of California San Diago
    • Los Angeles, California, United States, 90048
      • Cedars Sinai
    • 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, 32804
      • AdventHealth
    • 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
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • St. Vincent Cardiovascular Research Institute
  • 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
  • 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
    • Bronx, New York, United States, 10467
      • Montefiore
    • New York, New York, United States, 10032
      • Nyph/Cumc
    • Valhalla, New York, United States, 10595
      • Westchester Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Sentara
    • Richmond, Virginia, United States, 23298
      • Virgina Commonwealth University
  • 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: No

Description

Donor Inclusion

• Maastricht Category III DCD donor, defined as expected death after the withdrawal of life- supportive therapy (WLST)
• Donor age 18-49 years old inclusive
• Warm ischemic time (WIT) ≤ 30 mins, with warm ischemic time 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.

Donor Exclusion

• Previous cardiac surgery
• Known coronary artery disease
• Cardiogenic shock or myocardial infarction, or
• Sustained terminal ejection fraction (EF) of ≤ 50%, or
• Significant valve disease except for competent bicuspid aortic valve

Recipient Inclusion

• Primary heart transplant candidates
• Age ≥ 18 years old
• Signed: (1) written informed consent document; (2) authorization to use and disclose protected health information; and (3) consent to TransMedics' use of recipients' United Network for Organ Sharing (UNOS)/Organ Procurement and Transplantation Network (OPTN) data and recipients' Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) data.

Recipient Exclusion

• Prior solid organ or bone marrow transplant
• Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
• Multi-organ transplant
• Investigator unwilling to randomize to either arm.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DCD Heart Possible	Device: OCS Heart System; Preserving and assessing donor after circulatory death hearts for transplant
Active Comparator: Standard of Care Heart Only	Other: Cold Storage; Active comparator intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Patient survival 6 months post-transplant	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Utilization Rate	Utilization Rate, defined as the number of eligible DCD donor hearts that met the warm ischemic time limit above and were instrumented on the OCS Heart System that meet the acceptance criteria for transplantation after OCS Heart preservation divided by the total number of eligible DCD donor hearts that met the warm ischemic time limit above and were instrumented on the OCS Heart System.	Within 24 hours post-transplant

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient and graft survival	Patient and graft survival at 30 days post transplant	30 days
Patient and graft survival	Patient and graft survival at 30 days and initial hospital discharge, if later than 30 days	30 days or hospital discharge, if later than 30 days
Severe heart primary graft dysfunction	Severe heart primary graft dysfunction of the left and/or right ventricle, not including rejection of cardiac tamponade	24 hours post transplant
Post transplant Mechanical Circulatory Support (MCS)	Use of post-transplant mechanical circulatory support (LVAD, RVAD, BiVAD) for > 72 hours immediately post-transplant.	>72 hours immediately post-transplant
Patient survival at 1 year after transplant (collected post-approval)	Patient survival at 1 year after transplant (collected post-approval); comparison of DCD Heart Transplanted Recipients and SOC Heart Transplant Recipients (SOC1 + SOC2) through UNOS/OPTN database.	One year post-transplant.

Collaborators and Investigators

• Sponsor: TransMedics

Publications and helpful links

General Publications

• Shudo Y, Benjamin-Addy R, Koyano TK, Hiesinger W, MacArthur JW, Woo YJ. Donors after circulatory death heart trial. Future Cardiol. 2021 Jan;17(1):11-17. doi: 10.2217/fca-2020-0070. Epub 2020 Jul 6.

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2019
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): September 28, 2021

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (Actual): February 5, 2019

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Heart preservation; Beating heart transplant
• Other Study ID Numbers: OCS-CAR-03202019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes