Global Utilization And Registry Database for Improved heArt preservatioN

Recruiting

Trial ID: NCT04141605

Purpose

The primary objective of this study is to collect real-world clinical performance data to assess the clinical outcomes of patients receiving heart transplants using donor hearts transported via the SherpaPak CTS System. These results will be compared to outcomes of retrospective patients whose hearts were transported with the previous standard method.

Official Title

Global Utilization and Registry Database for Improved Heart Preservation

Stanford Investigator(s)

Yasuhiro Shudo, MD, PhD
Yasuhiro Shudo, MD, PhD

Clinical Assistant Professor, Cardiothoracic Surgery

Eligibility


Inclusion Criteria:

   - Donor and donor hearts matched to the prospective recipient based upon institutional
   medical practice

   - Registered male or female primary heart transplant candidates including pediatric
   candidates

Exclusion Criteria:

   - Donor and donor hearts that do not meet institutional clinical requirements for
   transplantation

   - When safe connection with the aorta cannot be made, e.g., due to lack of enough length
   of the aortic root

   - Patients who are incarcerated persons (prisoners)

   - Patients who have had a previous organ transplant

Intervention(s):

device: SherpaPak Cardiac Transport System

Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305