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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 22, 2020
Sponsor:
Information provided by (Responsible Party):
TransMedics

Tracking Information
First Submitted Date  ICMJE January 22, 2019
First Posted Date  ICMJE February 5, 2019
Last Update Posted Date January 22, 2020
Actual Study Start Date  ICMJE December 1, 2019
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
Survival [ Time Frame: 6 months ]
Patient survival 6 months post-transplant
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT03831048 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: May 21, 2019)
  • Patient and graft survival [ Time Frame: 30 days ]
    Patient and graft survival at 30 days post transplant
  • 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
  • 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
  • Post transplant Mechanical Circulatory Support (MCS) [ Time Frame: >72 hours immediately post-transplant ]
    Use of post-transplant mechanical circulatory support
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Donors After Circulatory Death Heart Trial
Official Title  ICMJE 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)
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Heart Transplant
Intervention  ICMJE
  • Device: OCS Heart System
    Preserving and assessing donor after circulatory death hearts for transplant
  • Other: Cold Storage
    Active comparator intervention
Study Arms  ICMJE
  • Experimental: DCD Heart Possible
    Intervention: Device: OCS Heart System
  • Active Comparator: Standard of Care Heart Only
    Intervention: Other: Cold Storage
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 21, 2019)
212
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03831048
Other Study ID Numbers  ICMJE OCS-CAR-03202019
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party TransMedics
Study Sponsor  ICMJE TransMedics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account TransMedics
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP