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Donors After Circulatory Death Heart Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03831048
Recruitment Status : Completed
First Posted : February 5, 2019
Last Update Posted : January 6, 2023
Sponsor:
Information provided by (Responsible Party):
TransMedics

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Transplant Device: OCS Heart System Other: Cold Storage Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : November 26, 2019
Actual Primary Completion Date : April 1, 2021
Actual Study Completion Date : September 28, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Survival [ Time Frame: 6 months ]
    Patient survival 6 months post-transplant


Secondary Outcome Measures :
  1. Utilization rate [ Time Frame: Within 24 hours post-transplant ]
    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.


Other Outcome Measures:
  1. Patient and graft survival [ Time Frame: 30 days ]
    Patient and graft survival at 30 days post transplant

  2. Patient and graft survival [ Time Frame: 30 days or hospital discharge, if later than 30 days ]
    Patient and graft survival at 30 days and initial hospital discharge, if later than 30 days

  3. Severe heart primary graft dysfunction [ Time Frame: 24 hours post transplant ]
    Severe heart primary graft dysfunction of the left and/or right ventricle, not including rejection of cardiac tamponade

  4. Post transplant Mechanical Circulatory Support (MCS) [ Time Frame: >72 hours immediately post-transplant ]
    Use of post-transplant mechanical circulatory support (LVAD, RVAD, BiVAD) for > 72 hours immediately post-transplant.

  5. Patient survival at 1 year after transplant (collected post-approval) [ Time Frame: One year post-transplant. ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03831048


Locations
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Sponsors and Collaborators
TransMedics
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: TransMedics
ClinicalTrials.gov Identifier: NCT03831048    
Other Study ID Numbers: OCS-CAR-03202019
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: January 6, 2023
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by TransMedics:
Heart preservation
Beating heart transplant