Global Utilization And Registry Database for Improved heArt preservatioN
- Conditions
- Heart DiseasesHeart FailureHeart Defects, Congenital
- Interventions
- Device: SherpaPak Cardiac Transport System
- Registration Number
- NCT04141605
- Lead Sponsor
- Paragonix Technologies
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 3000
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description SherpaPak CTS Patients SherpaPak Cardiac Transport System Patients whose donor heart was transported with the SherpaPak CTS
- Primary Outcome Measures
Name Time Method Survival 5 years The length of patient survival up to 5 years will be compared
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)
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 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
- Secondary Outcome Measures
Name Time Method CAV development five years Number of patients who developed CAV between 1 and 5 years post transplant will be compared
Hospitalizations one year Number of related hospitalizations post transplant
Retransplant five years The number of patients who were retransplanted will be compared
Trial Locations
- Locations (22)
Stanford University
🇺🇸Stanford, California, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Tufts University Medical Center
🇺🇸Boston, Massachusetts, United States
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Sentara Healthcare
🇺🇸Norfolk, Virginia, United States
University of Florida Health Shands Hospital
🇺🇸Gainesville, Florida, United States
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
Lutheran Hospital
🇺🇸Fort Wayne, Indiana, United States
Allgemeines Krankenhaus Wien
🇦🇹Vienna, Austria
Manchester University
🇬🇧Manchester, United Kingdom
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
University of Graz
🇦🇹Graz, Austria
NewYork-Presbyterian Columbia University Irving Medical Center
🇺🇸New York, New York, United States
Medstar Washington Hospital
🇺🇸Washington, District of Columbia, United States
Le Bonheur Children's Hospital
🇺🇸Memphis, Tennessee, United States
Kansas University Medical Center
🇺🇸Lawrence, Kansas, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Hospital ClÃnico Universitario de Valladolid
🇪🇸Valladolid, Spain
Duke University
🇺🇸Durham, North Carolina, United States
Pennslyvania State University
🇺🇸State College, Pennsylvania, United States