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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03831048
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
TransMedics

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 212 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 : December 1, 2019
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : December 31, 2021

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




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 ]
    The number of eligible DCD donor hearts that were instrumented on the OCS Heart System that meet the acceptance criteria for transplant divided by the total number of eligible DCD donor hearts that 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



Information from the National Library of Medicine

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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.

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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United States, Connecticut
Yale New Haven Hospital Not yet recruiting
New Haven, Connecticut, United States, 06510
Contact: Lynn Wilson       lynn.m.wilson@yale.edu   
Principal Investigator: Arnar Geirsson, MD         
United States, Florida
Tampa General Hospital Not yet recruiting
Tampa, Florida, United States, 33606
Contact: Courtney Nicholas    813-844-4914    courtneynicholas@tgh.org   
Principal Investigator: John Dunning, MD         
United States, Georgia
Emory University Hospital Not yet recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: Mani Daneshmand, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Kamila Drezek    617-724-2610    mailto:KDREZEK@mgh.harvard.edu   
Principal Investigator: David D'Alessandro, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Sarah Casalinova    919-613-5621    sarah.casalinova@duke.edu   
Principal Investigator: Jacob Schroder, MD         
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Kaelin Grant    608-262-1551    grantk@surgery.wisc.edu   
Principal Investigator: Jason Smith, MD         
Sponsors and Collaborators
TransMedics

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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 2, 2020
Last Verified: December 2019

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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