OCS Heart Perfusion Post-Approval Registry

Status Active, not recruiting

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

Transplant

Clinical Trial Details

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

View Details

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