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Clinical Trial Summary

Single-arm, prospective, multi-center observational study of the clinical use of the ex-vivo perfusion of the heart with the Organ Care System (OCS™)


Clinical Trial Description

This is an observational study at two centers that will enroll minimum of 60 heart transplant recipients transplanted with donor heart preserved using the OCS™ Heart System. All consented subjects who receive OCS™-preserved heart transplants will be approached for participation. The study will evaluate short and long-term effectiveness of the OCS™ Heart System for heart transplantation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03687723
Study type Observational
Source Hannover Medical School
Contact Fabio Ius, Dr.
Phone +49 511-532-2125
Email Ius.Fabio@mh-hannover.de
Status Recruiting
Phase
Start date October 2016
Completion date March 2025

See also
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Completed NCT00690157 - Registry of Patients Referred for Heart Transplantation N/A
Completed NCT00123331 - Rapamycin Use in Calcineurin Inhibitor (CNI)-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation Phase 4