Clinical trials

This single-center pilot study will evaluate the accuracy and feasibility of non-invasive cardiac output measurement using the UltraTrac device in pediatric patients aged 0-21 years undergoing standard-of-care diagnostic cardiac catheterization. UltraTrac integrates ultrasound with impedance cardiography (ICG) to refine stroke volume and cardiac output calculations. During catheterization, trained staff will apply four surface-skin electrodes and a Doppler probe and obtain UltraTrac measurements without altering standard clinical care. The primary objective is to assess concordance between algorithm-derived cardiac output and gold-standard invasive measurements (Fick or thermodilution). The secondary objective is to evaluate human-factors issues reported by clinicians during device use. The study will enroll 50 hemodynamically stable pediatric participants, with up to 60 screened to account for screen failures. UltraTrac poses no more than minimal risk, using noninvasive sensors comparable to standard electrocardiogram (ECG) and Doppler procedures. Measurements will be performed only when clinically appropriate, and no UltraTrac data will be used to guide patient care.

This study will test the use of the UltraTrac™ system, a small, noninvasive device that uses electrodes on the skin and a small ultrasound sensor to provide measurements of cardiac function in a wide of subjects. UltraTrac estimates cardiac output and other hemodynamic parameters without needles or invasive procedures. Up to 400 generally healthy volunteers, from infants to older adults, will take part in a single study visit lasting about one hour. During the visit, study staff place small adhesive electrodes on the skin and a lightweight ultrasound sensor on the neck or thigh. The device records heart-related signals while the participant is lying down, sitting, and during simple movements such as repositioning, passive leg raise, or light exercise (like walking or pedaling in place). The study evaluates how often the UltraTrac device can collect good-quality signals and how consistent the measurements are across different ages and activity levels. There is no direct medical benefit to participants. The risks are minimal, such as mild skin irritation from adhesive electrodes. The information collected will help improve the UltraTrac system and support future regulatory review so that noninvasive cardiac monitoring may become more widely available, especially for children and other patients who are not able to undergo invasive monitoring.