Donor After Circulatory Death Heart CAP Trial
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|ClinicalTrials.gov Identifier: NCT04615182|
Recruitment Status : Recruiting
First Posted : November 4, 2020
Last Update Posted : April 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Heart Transplant||Device: Transplant||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||December 12, 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2025|
|Experimental: OCS Preservation||
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.
- Patient survival [ Time Frame: 6 months post-transplant ]Patient survival at 6 months post-transplant.
- 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.
- Patient and graft survival [ Time Frame: 30 days post-transplant ]Patient and graft survival at 30 days post-transplant
- 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
- 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
- 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.
- Patient survival [ Time Frame: 1 year after transplant. ]Patient survival at 1 year after transplant.
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
|Contact: Raicca Haqqi, Bachelorsfirstname.lastname@example.org|
|Contact: Kausar Qidwai, Mastersemail@example.com|