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Clinical Trial Summary

This is a prospective observational pilot study of suitability of autonomic monitoring via the VU-AMS device for prediction of neurocardiogenic syncope (NCS) in children referred to cardiopulmonary exercise testing (CPET) for a diagnosis of syncope. The study population is children referred for CPET to evaluate for neurocardiogenic syncope. The purpose is to describe autonomic function during rest and exercise and determine the positive predictive value of autonomic function measurements against the gold standard for diagnosis of neurocardiogenic syncope, the CPET. Children presenting for CPET with chest pain or who are status post orthotopic heart transplantation will serve as positive and negative controls respectively.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05907018
Study type Observational
Source Children's Hospital Medical Center, Cincinnati
Contact
Status Enrolling by invitation
Phase
Start date May 12, 2023
Completion date December 2025

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