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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03831048
Study type Interventional
Source TransMedics
Contact
Status Completed
Phase N/A
Start date November 26, 2019
Completion date September 28, 2021

See also
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