Arrhythmia Clinical Trial
Official title:
Relationship Between Functional Health Status and Ventricular Performance After Fontan (A Trial Conducted by the Pediatric Heart Network)
The purpose of this cross-sectional study was to determine the interrelationships between health status and measures of cardiac performance in children 6 to 18 years of age with congenital heart disease who have undergone a Fontan procedure as surgical treatment for functional single ventricle. The goal was to develop a data set that will permit identification of a clinically relevant endpoint for subsequent trials of medical management of the Fontan patient.
BACKGROUND:
Children born with one functional ventricle and who undergo a Fontan procedure, have a
higher incidence of late complications than other congenital heart patients. While the
Fontan procedure results in restoring near-normal systemic oxygen saturation, there are
recognized problems and little information about the overall health status, functional
status and ventricular performance in these children.
DESIGN NARRATIVE:
This cross-sectional observational study included children 6-18 years of age who had
undergone a Fontan procedure for a congenital cardiac defect. Prospective data collection
for each patient occured within a 3 month time period and included cardiac MRI,
echocardiography, serology and exercise testing. Historical clinical and surgical data, as
well as parent and child self reports of health status, was collected.
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Observational Model: Case-Crossover, Time Perspective: Prospective
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