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Clinical Trial Summary

The objective of this post-approval registry is to provide additional real-world evidence of the performance of the OCS Heart System to preserve DBD and DCD donor hearts.


Clinical Trial Description

Multi-center, observational post-approval registry to: 1. compare patient and graft survival of adult primary heart transplant recipients receiving DBD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period, and 2. compare patient and graft survival of adult primary heart transplant recipients receiving DCD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05047068
Study type Observational [Patient Registry]
Source TransMedics
Contact
Status Active, not recruiting
Phase
Start date September 13, 2021
Completion date December 2029

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