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UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease

Study acronym: UltraTrac
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07866573
Lead Sponsor University of Minnesota
Conditions
(from sponsor)		 Congenital Heart Disease, Cardiac Output, Hemodynamic Monitoring, Pediatric Heart Disease
Related terms Heart Defects, Congenital
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov