Global Utilization And Registry Database for Improved heArt preservatioN (GUARDIAN)
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|ClinicalTrials.gov Identifier: NCT04141605|
Recruitment Status : Enrolling by invitation
First Posted : October 28, 2019
Last Update Posted : August 10, 2022
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|Condition or disease||Intervention/treatment|
|Heart Diseases Heart Failure Heart Defects, Congenital||Device: SherpaPak Cardiac Transport System|
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]|
|Estimated Enrollment :||800 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Global Utilization and Registry Database for Improved Heart Preservation|
|Actual Study Start Date :||February 14, 2020|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2024|
SherpaPak CTS Patients
Patients whose donor heart was transported with the SherpaPak CTS
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
Standard Transport Patients
Patients whose donor heart was transported with a method other than SherpaPak CTS in the past two years
- 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
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04141605
|Principal Investigator:||Andreas Zuckermann, MD||ALLGEMEINES KRANKENHAUS WIEN|
|Responsible Party:||Paragonix Technologies|
|Other Study ID Numbers:||
|First Posted:||October 28, 2019 Key Record Dates|
|Last Update Posted:||August 10, 2022|
|Last Verified:||August 2022|
|Individual Participant Data (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.|
|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|
Heart Defects, Congenital