Heart Transplant Clinical Trial
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)
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.
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. ;
Status | Clinical Trial | Phase | |
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Completed |
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