Global Utilization And Registry Database for Improved heArt preservatioN

Trial ID or NCT#

NCT04141605

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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
View All Criteria
Show Less

Investigator(s)

Yasuhiro Shudo, MD, PhD
Yasuhiro Shudo, MD, PhD
Cardiothoracic surgeon, Cardiac surgeon, Cardiovascular surgeon, Lung transplant surgeon
Clinical Assistant Professor, Cardiothoracic Surgery

View on ClinicalTrials.gov