We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04615182
Previous Study | Return to List | Next Study

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 : Completed
First Posted : November 4, 2020
Last Update Posted : September 14, 2022
Sponsor:
Information provided by (Responsible Party):
TransMedics

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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
Actual Study Completion Date : June 29, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Show Show 25 study locations
Sponsors and Collaborators
TransMedics
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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: September 14, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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