Heart Defects, Congenital, Heart Diseases, Heart Failure
Conditions
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 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.
Interventions
DEVICESherpaPak 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.
Sponsors
Paragonix Technologies
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | 5 years | The length of patient survival up to 5 years will be compared |
| Number of Patients with Right Ventricular Dysfunction | 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 | one year | Length of time patient admitted to the intensive care unit post transplant |
| Length of Hospital Stay | one year | Length of time before patient is discharged from the hospital post transplant |
| Number of Patients with Primary Graft Dysfunction | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CAV development | five years | Number of patients who developed CAV between 1 and 5 years post transplant will be compared |
| Retransplant | five years | The number of patients who were retransplanted will be compared |
| Hospitalizations | one year | Number of related hospitalizations post transplant |
Countries
Austria, Spain, United Kingdom, United States
Outcome results
None listed