Clinical trial NCT04141605: Global Utilization And Registry Database for Improved heArt preservatioN
Official title: Global Utilization and Registry Database for Improved Heart Preservation
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Heart Diseases
Heart Failure
Heart Defects, Congenital
Lead sponsor: Paragonix Technologies
Sponsor class: INDUSTRY
First posted: 2019-10-28
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients registered on the heart transplant registry who receive a heart transplant at a participating center and do not meet any of the exclusion criteria.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients with Primary Graft Dysfunction
timeFrame: one year
measure: Number of Patients with Right Ventricular Dysfunction
timeFrame: one year
measure: Length of ICU Stay
timeFrame: one year
measure: Length of Hospital Stay
timeFrame: one year
measure: Survival
timeFrame: 5 years
Secondary outcomes:
measure: Hospitalizations
timeFrame: one year
measure: CAV development
timeFrame: five years
measure: Retransplant
timeFrame: five years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Washington DC
country: United States
facility: Medstar Washington Hospital
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida Health Shands Hospital
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Fort Wayne
country: United States
facility: Lutheran Hospital
state: Indiana
city: Lawrence
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Boston
country: United States
facility: Tufts University Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: New York
country: United States
facility: NewYork-Presbyterian Columbia University Irving Medical Center
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: State College
country: United States
facility: Pennslyvania State University
state: Pennsylvania
city: Memphis
country: United States
facility: Le Bonheur Children's Hospital
state: Tennessee
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Norfolk
country: United States
facility: Sentara Healthcare
state: Virginia
city: Graz
country: Austria
facility: University of Graz
city: Vienna
country: Austria
facility: Allgemeines Krankenhaus Wien
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Manchester
country: United Kingdom
facility: Manchester University
Study officials:
affiliation: ALLGEMEINES KRANKENHAUS WIEN
name: Andreas Zuckermann, MD
role: PRINCIPAL_INVESTIGATOR
References: