An observational study in Pectus Excavatum and Cardiac Anomaly, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to participants aged 1 Day to 30 Years. Per ClinicalTrials.gov, last updated 2025-01-29.
Sponsored by Children's Hospital Medical Center, Cincinnati · Observational
The Fontan Procedure is a palliative surgical procedure used in pediatric patients with one functional ventricle. The procedure, a series of stepwise operations that alter cardiorespiratory physiology, separate the systemic and pulmonary circulations to create Fontan physiology, where the systemic venous blood flows passively and without ventricular thrust into the pulmonary circulation. The hallmark of the Fontan circulation is a sustained, abnormally elevated central venous pressure combined with decreased cardiac output, especially during periods of increased demands. Results of several studies in Fontan patients have shown reduced parasympathetic and sympathetic activity compared to controls. In children with congenital heart disease, a differential diagnosis of autonomic dysfunction may be part of their pathophysiology, a compensatory mechanism, a consequence of surgical procedures or a combination of these.
In children, measurement of ANS function is equally important. Children with single ventricle physiology (and other cardiac conditions) have routine surveillance and cardiac magnetic resonance (CMR) imaging to monitor for disease progression. While autonomic data is routinely collected and is available from these scans, these data are rarely, collected and analyzed; however, our group has shown feasibility. Therefore, autonomic data is usually unavailable in children. Despite the availability of agerelated normal values, the predictive power of autonomic activity is understudied in children and there are no published studies of quantification of autonomic data in this population.
Patients presenting for clinically indicated CMR scans with planned cine sequence and use of a respiratory bellows.
Exclusion Criteria:
Patients undergoing cardiac MRI for Fontan,
Other: VU-AMS device
Patients undergoing thoracic MRI for chest wall deformity.
Other: VU-AMS device
Patients will wear the VU-AMS monitor prior to MRI.
80% availability of respiratory sinus arrhythmia from cardiac MRI (magnetic resonance imaging)
Data collected during MRI
Time frame: Through MRI completion up to one hour
Describe difference in respiratory sinus arrhythmia in participants with Fontan
Collection of data from the cardiac MRI
Time frame: Through MRI completion up to one hour
Describe difference in respiratory sinus arrhythmia in participants with pectus
Collection of data from the cardiac MRI
Time frame: Through MRI completion up to one hour
Compare estimate of pre-ejection period (PEP)
Collection of data from VU-AMS monitor
Time frame: Prior to MRI scan up to 10 minutes
Compare estimate of pre-ejection period (PEP)
Collection of data from the cardiac MRI
Time frame: Through MRI completion up to one hour
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Children's Hospital Medical Center, Cincinnati