Global Utilization And Registry Database for Improved heArt preservatioN

Study Overview
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Brief Summary
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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
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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 up to 3000 patients. Subjects will be followed from transplant through one-year post-transplantation (i.e., 24 hours post-transplant, discharge, 30-days, 1-year, 2-years, 3-years, 4-years, 5-years). 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, Inotrope use, CAV diagnosis, rejection, and survival. 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.

Official Title
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Global Utilization and Registry Database for Improved Heart Preservation

Conditions
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Heart Diseases, Heart Failure, Heart Defects, Congenital

Intervention / Treatment
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* Device: SherpaPak Cardiac Transport System


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SherpaPak CTS Patients<br>Patients whose donor heart was transported with the SherpaPak CTS | Device: SherpaPak Cardiac Transport System<br>* 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.<br>* Other names: SherpaPak CTS;|
| Standard Transport Patients<br>Patients whose donor heart was transported with a method other than SherpaPak CTS in the past two years | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients with Primary Graft Dysfunction | 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) | one year | 
| Number of Patients with Right Ventricular Dysfunction | 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 | one year | 
| Length of ICU Stay | Length of time patient admitted to the intensive care unit post transplant | one year | 
| Length of Hospital Stay | Length of time before patient is discharged from the hospital post transplant | one year | 
| Survival | The length of patient survival up to 5 years will be compared | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalizations | Number of related hospitalizations post transplant | one year | 
| CAV development | Number of patients who developed CAV between 1 and 5 years post transplant will be compared | five years | 
| Retransplant | The number of patients who were retransplanted will be compared | five years |