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

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

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

Sponsors & Collaborators

• University of California, Los Angeles

  collaborator OTHER

• Columbia University

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• Newark Beth Israel Medical Center

  collaborator OTHER

• Cedars-Sinai Medical Center

  collaborator OTHER

• Groupe Hospitalier Pitie-Salpetriere

  collaborator OTHER

• Papworth Hospital NHS Foundation Trust

  collaborator OTHER_GOV

• Azienda Ospedaliera S. Maria della Misericordia

  collaborator OTHER

• Royal Brompton & Harefield NHS Foundation Trust

  collaborator OTHER

• Indiana University

  collaborator OTHER

• TransMedics

  lead INDUSTRY

Principal Investigators

• Abbas Ardehali, MD · University of California, Los Angeles

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-03-31

Primary Completion

2013-10-31

Completion

2013-11-30

Countries

• United States
• France
• Italy
• United Kingdom

Study Locations