NCT00855712

Randomized Study of Organ Care System Cardiac for Preservation of Donated Hearts for Eventual Transplantation

Prospective, Multicenter, Randomized, Clinical Investigation of TransMedics Organ Care System (OCS) for Cardiac Use

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: TransMedics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to compare survival of both patients and newly transplanted hearts following heart transplantation among patients who were transplanted with donated hearts preserved on ice and those who were transplanted with donated hearts using the Organ Care System (OCS). The Organ care system preserves the hearts in a warm blood perfused beating state. The study also compares the number of rejection episodes, heart related adverse events, ICU time, and ventilation time between the two groups. The study is considered a success if survival in the OCS group was not inferior to the ice group.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Organ Care System	The Organ Care System (OCS) is a portable organ perfusion and monitoring system intended to preserve a donated heart in a near normal physiologic beating state during transport for eventual transplantation into a recipient. The OCS maintains organ viability by providing a controlled environment that simulates near-normal physiological conditions, continuously perfusing the donated heart with warm, oxygenated blood, supplemented with the Solution Set. The blood is collected from the donor and continuously circulated to the organ in a closed circuit along with the Solution. The OCS preserves and monitors the organ's perfusion and metabolic state after explantation from a donor and connection to the device, during transportation to the recipient site, and until disconnection from the device.
DEVICE	Cold Cardioplegia Solution	This is the standard of care solutions used to arrest and preserve the donated heart during transport until arrival at recipient hospital

Timeline

• Start date: 2009-03-01
• Primary completion: 2013-10-01
• Completion: 2013-11-01
• First posted: 2009-03-04
• Last updated: 2020-06-09

Locations

11 sites across 4 countries: United States, France, Italy, United Kingdom