Global Utilization And Registry Database for Improved heArt preservatioN (GUARDIAN)

• ClinicalTrials.gov Identifier: NCT04141605
• Recruitment Status: Enrolling by invitation
• First Posted: October 28, 2019
• Last Update Posted: August 10, 2022
• Sponsor: Paragonix Technologies
• Information provided by (Responsible Party): Paragonix Technologies

Tracking Information

• First Submitted Date: October 16, 2019
• First Posted Date: October 28, 2019
• Last Update Posted Date: August 10, 2022
• Actual Study Start Date: February 14, 2020
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 24, 2019)

• Number of Patients with Primary Graft Dysfunction [ Time Frame: one year ]
  Less than 40% LVEF by echocardiography or hemodynamics with RAP greater than 15 mm Hg, PCWP greater than 20 mm Hg, CI less thann 2 L/min/m^2, hypotension with MAP less than 70 mm Hg (lasting more than 1 hour)
• Number of Patients with Right Ventricular Dysfunction [ Time Frame: one year ]
  hemodynamics with RAP grater than 15mm Hg, PCWP less than 15 mm Hg, CI less than 2 L/min/m^2, TPG less than 15mm Hg/pulmonary artery systolic pressure less than 50 mmHg OR need for RVAD
• Length of ICU Stay [ Time Frame: one year ]
  Length of time patient admitted to the intensive care unit post transplant
• Length of Hospital Stay [ Time Frame: one year ]
  Length of time before patient is discharged from the hospital post transplant

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 24, 2019)

• Hospitalizations [ Time Frame: one year ]
  Number of related hospitalizations post transplant
• Quality of Recovery [ Time Frame: one year ]
  Karnofsky score of patients as they recover will be compared. 100 is the highest score and 0 is the lowest. Higher scores are better outcomes and lower scores are worse outcomes.
• Speed of Recovery [ Time Frame: one year ]
  How quickly patients achieve a higher Karnofsky score during recovery will be compared. 100 is the highest score and 0 is the lowest. Higher scores are better outcomes and lower scores are worse outcomes.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Global Utilization And Registry Database for Improved heArt preservatioN
• Official Title: Global Utilization and Registry Database for Improved Heart Preservation
• Brief Summary: 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.

Detailed Description

This study is a registry study collecting data both retrospectively from patients already transplanted and prospectively from consecutively enrolled patients for heart transplantation. The study is a chart review study.

Ongoing eligible recipients will undergo heart transplantation according to standard practices at each participating institution.

This study will be conducted at an estimated 25 institutions globally and will have about 500 patients. Subjects will be followed from transplant through one-year post-transplantation (i.e., 24 hours post-transplant, discharge, 30-days, and 1-year).

GUARDIAN provides critical and contemporary data on patient outcomes, with additional insight into risk factors and patient-related indices. Both donor and recipient information along with procedural details (including transportation) will be collected to provide information for major discrete endpoints such as death, primary graft dysfunction, right ventricular dysfunction, CPB weaning and Inotrope use.

Information about re-hospitalizations and re-transplantations is vital to address the integrated endpoint of days alive out of hospital, which is particularly relevant for this patient population. In addition, the number of in-hospital days and ICU time is closely tracked as the major resource utilized, after the initial transplant.

• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: 1 Year
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients registered on the heart transplant registry who receive a heart transplant at a participating center and do not meet any of the exclusion criteria.

Condition

• Heart Diseases
• Heart Failure
• Heart Defects, Congenital

Intervention

Device: SherpaPak Cardiac Transport System

The Paragonix SherpaPak Cardiac Transport System ("SherpaPak CTS") is an ultraportable hypothermic preservation and transport system intended for use with donor hearts. The device is a legally marketed, FDA cleared medical device in the United States and CE Marked medical device in the European Union.

The SherpaPak CTS consists of multiple components: 1) outer transport shipper which contains within various non-ice based temperature controlled packaging elements, 2) an inner and outer hard shell assembly which provides a rigid barrier enclosure in which the heart is immersed and suspended in a cold storage solution cleared for use in storing and transporting donor hearts, 3) a data logger that monitors and displays the temperature of the cold storage solution in which the heart is stored during transport, and 4) four size heart connectors designed to accommodate various size aortic stem diameters by which donor hearts are attached.

Other Name: SherpaPak CTS

Study Groups/Cohorts

• SherpaPak CTS Patients
  Patients whose donor heart was transported with the SherpaPak CTS
  Intervention: Device: SherpaPak Cardiac Transport System
• Standard Transport Patients
  Patients whose donor heart was transported with a method other than SherpaPak CTS in the past two years

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: March 8, 2021): 800
• Original Estimated Enrollment (submitted: October 24, 2019): 500
• Estimated Study Completion Date: December 31, 2024
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT04141605
• Other Study ID Numbers: PGX-002
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Data will only be released as a summary of the results found at each center and overall. No individual patient data will be released.

• Current Responsible Party: Paragonix Technologies
• Original Responsible Party: Same as current
• Current Study Sponsor: Paragonix Technologies
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Andreas Zuckermann, MD; ALLGEMEINES KRANKENHAUS WIEN

• PRS Account: Paragonix Technologies
• Verification Date: August 2022