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Donor After Circulatory Death Heart CAP 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: NCT04615182
Recruitment Status : Active, not recruiting
First Posted : November 4, 2020
Last Update Posted : April 8, 2022
Sponsor:
Information provided by (Responsible Party):
TransMedics

Brief Summary:
The Portable Organ Care System (OCS™) Heart for Resuscitating, Preserving and Assessing Hearts Donated after Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)

Condition or disease Intervention/treatment Phase
Heart Transplant Device: Transplant Not Applicable

Detailed Description:
To enable continued clinical access to DCD heart transplantation in the U.S. and to continue to collect additional data on the performance 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Portable Organ Care System (OCS™) Heart For Resuscitation, Preservation and Assessment of Hearts From Donors After Circulatory Death Continued Access Protocol (OCS DCD Heart CAP)
Actual Study Start Date : November 25, 2020
Actual Primary Completion Date : December 21, 2021
Estimated Study Completion Date : June 24, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OCS Preservation Device: Transplant
To enable continued clinical access to DCD heart transplantation in the U.S. and to continue to collect additional data on the performance 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.




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


Secondary Outcome Measures :
  1. Utilization Rate [ Time Frame: 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 post-transplant ]
    Patient and graft survival at 30 days post-transplant

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

  3. Primary Graft Dysfunction (PGD) [ Time Frame: 24 hours post transplant ]
    Severe heart primary graft dysfunction (PGD) (left or right ventricle) (not including rejection or cardiac tamponade) according to ISHLT consensus manuscript

  4. Post-Transplant Mechanical Circulatory Support [ 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 [ Time Frame: 1 year after transplant. ]
    Patient survival at 1 year after transplant.



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

Recipient Inclusion Criteria:

  • • 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' UNOS/OPTN data and recipients' INTERMACS data.

Recipient Exclusion Criteria:

  • Prior solid organ or bone marrow transplant

    • Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
    • Multi-organ transplant.

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): NCT04615182


Locations
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Sponsors and Collaborators
TransMedics
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Responsible Party: TransMedics
ClinicalTrials.gov Identifier: NCT04615182    
Other Study ID Numbers: OCS-CAR-08242020
First Posted: November 4, 2020    Key Record Dates
Last Update Posted: April 8, 2022
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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