Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07866573
NA

UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease

Sponsor: University of Minnesota

View on ClinicalTrials.gov

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

DEVICE

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