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UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
Sponsor: University of Minnesota
Summary
This pilot feasibility study will evaluate UltraTrac, an investigational noninvasive wearable device for continuous cardiac output monitoring, in patients with congenital heart disease. UltraTrac integrates impedance cardiography and carotid Doppler ultrasound to estimate cardiac output. Participants undergoing clinically indicated cardiac catheterization, cardiac MRI, or cardiac intensive care unit monitoring will have UltraTrac measurements collected during routine clinical care. UltraTrac measurements will be compared with reference standard or clinical hemodynamic measurements, including thermodilution, direct Fick method, cardiac magnetic resonance imaging-derived cardiac output, and clinical hemodynamic assessments before and after vasoactive medication changes. UltraTrac data will not be used to guide clinical decision-making.
Official title: UltraTrac for Noninvasive Cardiac Output Monitoring in Patients With Congenital Heart Disease: A Multi-Setting Pilot Feasibility Study
Key Details
Gender
All
Age Range
0 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2026-11-01
Completion Date
2030-06-30
Last Updated
2026-10-08
Healthy Volunteers
No
Interventions
UltraTrac
UltraTrac is an investigational wearable hemodynamic monitoring device that integrates impedance cardiography and carotid Doppler ultrasound into a single noninvasive platform. In this study, UltraTrac will be used only as an observational monitoring device. UltraTrac measurements will not guide clinical decision-making, and all clinical management will proceed according to standard of care.
Locations (1)
M Health Fairview University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, United States