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Sponsor-Initiated OCS Heart Perfusion Registry — OHP-II  

Heart Transplant Clinical Trial

Official title:
Sponsor-Initiated OCS Heart Perfusion (OHP-II) Registry

Clinical Trial Summary

OHP-II Registry is a sponsor-initiated, multi-center, observational post-approval registry.

Clinical Trial Description

The objective of this sponsor-initiated OHP-II Registry is to collect data on the post-transplant clinical outcomes of all donor hearts preserved and assessed on the OCS Heart System and document the performance of the OCS device in the real-world setting. All heart transplant recipients who are transplanted with an OCS perfused donor heart are eligible for this registry. Up to 5,000 subjects will be enrolled. All interested U.S. Heart transplant centers that use the OCS Heart System for donor heart perfusion will constitute the OHP-II Registry participating centers. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05915299
Study type Observational [Patient Registry]
Source TransMedics
Contact Raicca Haqqi
Phone 9788090620
Email rhaqqi@transmedics.com
Status Recruiting
Phase
Start date August 25, 2023
Completion date August 31, 2033
View Details
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