GUARDIAN Registry for Heart Transplant Outcomes
This study, called GUARDIAN, is collecting information on patients who receive heart transplants. It aims to see how well donor hearts transported using the SherpaPak Cardiac Transport System (a special device for keeping hearts cold during transport) perform compared to older methods. Researchers will look at how many patients experience problems like primary graft dysfunction (when the new heart doesn't work well right away) or right ventricular dysfunction (a problem with one of the heart's pumping chambers) one year after transplant, and how long patients stay in the ICU. You may be able to join if you are a male or female heart transplant candidate, including children, whose donor heart meets institutional requirements. This study is currently collecting data from past and new patients.
- Study design
- This is an observational registry study that will include up to 3000 patients globally. It collects data from existing patient records and new patients undergoing heart transplantation.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed from transplant through one year post-transplantation, with data collected at various time points up to five years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Global Utilization And Registry Database for Improved heArt preservatioN
At a glance
Conditions
NCT04141605
Where you'd take part
This study runs at 22 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
AdventHealth Orlando
Orlando, Floridano site contact published
Allgemeines Krankenhaus Wien
Vienna, Austriano site contact published
Baylor University Medical Center
Dallas, Texasno site contact published
Cincinnati Children's Hospital
Cincinnati, Ohiono site contact published
Duke University
Durham, North Carolinano site contact published
Hospital Clínico Universitario de Valladolid
Valladolid, Spainno site contact published
Hospital Universitario 12 de Octubre
Madrid, Spainno site contact published
Kansas University Medical Center
Lawrence, Kansasno site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Andreas Zuckermann, MD · PRINCIPAL_INVESTIGATOR · ALLGEMEINES KRANKENHAUS WIEN
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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Inclusion
Exclusion
What this trial measures
- Number of Patients with Primary Graft Dysfunctionone 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 Dysfunctionone 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 Stayone year
Length of time patient admitted to the intensive care unit post transplant
- Length of Hospital Stayone year
Length of time before patient is discharged from the hospital post transplant
- Survival5 years
The length of patient survival up to 5 years will be compared