The EXPAND Heart Trial

Condition/Intervention: Heart transplant

Eligibility

Key Inclusion Criteria

  • Registered primary heart transplant candidate
  • At least 18 years old
  • Signed informed consent document and authorization to use and disclose protected health information

Key Exclusion Criteria

  • Prior solid organ or bone marrow transplant
  • Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
  • Pregnant women
  • Multi-organ transplant

Full Study Name

International Trial to Evaluate the Safety and Effectiveness of the Portable Organ Care System™ (OCS) Heart for Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation (EXPAND Heart Trial) (IRB no. 38084)

Summary

The purpose of this study is two-fold: to evaluate the ability of the Organ Care System™ (OCS) device to make more hearts available for transplantation, and to study clinical outcomes in heart transplant recipients who receive donor hearts preserved using the OCS device.

The Organ Care System is an investigational system for protecting and transporting a donor heart to the recipient. The heart is kept in a beating state during transport and is then transplanted into the recipient. Researchers will examine whether hearts that are often not considered suitable for transplantation can be transplanted using the OCS device.

Financial disclosure: Jon Kobashigawa, MD, has a relationship with the sponsor of the study as follows:

  • Serves on the Steering Committee to provide expert consultant services for the sponsor but has not received and does not anticipate receiving any financial compensation

Status

Active

Date Last Updated

07/15


Principal Investigator

Fardad Esmailian, MD

Co-Investigators

Francisco Arabia, MD
Lawrence Czer, MD
Jon Kobashigawa, MD