UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT07866573
Status
Not Yet Recruiting

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Conditions

  • Cardiac Output
  • Congenital Heart Disease
  • Hemodynamic Monitoring
  • Pediatric Heart Disease

Eligibility Criteria

Sex
ALL
Age
0 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • UltraTrac — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Oct 8, 2026
Start date
Nov 1, 2026
Status verified
Oct 2026
Primary completion
Nov 30, 2029
Completion
Jun 30, 2030

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Cardiac Catheterization Laboratory UltraTrac Monitoring
    Participants undergoing clinically indicated cardiac catheterization will have UltraTrac measurements obtained and compared with thermodilution and/or direct Fick cardiac output measurements obtained as part of standard clinical care.
  • Experimental: Cardiac MRI UltraTrac Monitoring
    Participants undergoing clinically indicated cardiac MRI will have UltraTrac measurements obtained near the time of cardiac MRI and compared with CMR-derived cardiac output measurements obtained as part of standard clinical care.
  • Experimental: Cardiac Intensive Care Unit UltraTrac Monitoring
    Participants admitted to the cardiac intensive care unit will have UltraTrac measurements obtained before and after clinically indicated introduction or titration of vasoactive medications. UltraTrac trending will be compared with concurrent clinical hemodynamic assessments.

Primary Outcome Measure

Agreement Between UltraTrac-Derived Cardiac Output and Reference Standard Cardiac Output During Cardiac Catheterization [ Time Frame: Periprocedural cardiac catheterization ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M Health Fairview University of Minnesota Masonic Children's HospitalMinneapolisMinnesota55454
Juan Carlos Samayoa
[email protected]

Find similar trials in Minneapolis, MN

By research site
M Health Fairview University of Minnesota Masonic Children's Hospital· Minneapolis, MN

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