Impact of Transcatheter Fontan Stenting on Liver Stiffness and Exercise Ability in Single-Ventricle Patients Aged 12 to 21

What this Trial Is About

Researchers are evaluating the effects of Fontan stent placement on exercise capacity and liver stiffness in patients aged 12 to 21 years who have single-ventricle heart conditions and have undergone Fontan palliation. The study aims to understand how this stenting procedure impacts these patients clinically, focusing on changes measured by exercise testing and liver scans. This observational study is sponsored by Childrens Hospital Los Angeles and follows patients who require this procedure during their care. Participants will undergo Fontan stent placement for extracardiac Fontan conduit stenosis as determined by their primary heart specialist. The study does not involve assigning treatments but follows patients who receive this stent placement during their usual clinical care. Two main diagnostic tests are used cardiopulmonary exercise testing on a cycle ergometer and shear wave elastography scans of the liver, performed before and after the stenting procedure at specific intervals. During the study, participants will complete two exercise tests and three liver stiffness scans over the course of about one year. These tests help researchers measure changes in exercise capacity and liver stiffness after stent placement. The study includes monitoring participants through standard clinical evaluations, and the main outcomes will be assessed one year after enrollment to understand the procedures impact over time.

Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity