Heart EXPAND Continued Access Protocol

Status Completed

Clinical Trial Summary

The OCS™ Heart System will be used to preserve and assess donor hearts that do not meet current standard donor heart acceptance criteria for transplantation in this continued access protocol.

Clinical Trial Description

To provide additional data evaluating the safety and effectiveness of the OCS™ Heart System to preserve and assess donor hearts that do not meet current standard donor heart acceptance criteria (as identified above) for transplantation to potentially improve donor heart utilization for transplantation at a range of transplant centers in the U.S. and to permit patients and physicians access to the OCS Heart System while a PMA application is under preparation and review. ;

Study Design

Related Conditions & MeSH terms

Heart Transplant

Clinical Trial Details

NCT number	NCT03835754
Study type	Interventional
Source	TransMedics
Contact
Status	Completed
Phase	N/A
Start date	April 17, 2019
Completion date	August 12, 2022

View Details

See also
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