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UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease

ConditionsCongenital Heart DiseaseCardiac OutputHemodynamic MonitoringPediatric Heart Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-80
SponsorUniversity of Minnesota

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

0-80 years old

Participant weight of at least 2 kg

Diagnosis of congenital heart disease of any anatomic type, including but not limited to repaired or unrepaired single ventricle physiology, biventricular congenital heart disease, valvular disease, septal defects, and conotruncal anomalies

Clinically indicated cardiac catheterization, cardiac MRI, or cardiac intensive care unit admission during the study enrollment period

Disqualifiers

Known allergy or prior skin reaction to adhesive electrodes or ultrasound gel

Skin breakdown, wound, or infection at any proposed electrode or probe placement site that would preclude safe device application

Hemodynamic instability at the time of enrollment that, in the judgment of the treating clinician, would preclude safe participation in research procedures

Known carotid artery abnormality, prior carotid surgery, or anatomic variant that would preclude reliable carotid Doppler signal acquisition

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

70 Participants
are divided into 3 treatment groups
Group A: Cardiac Catheterization Laboratory UltraTrac MonitoringExperimental treatment 1 intervention
Group B: Cardiac MRI UltraTrac MonitoringExperimental treatment 1 intervention
Group C: Cardiac Intensive Care Unit UltraTrac MonitoringExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Agreement Between UltraTrac-Derived Cardiac Output and Reference Standard Cardiac Output During Cardiac Catheterization

Agreement between cardiac output measurements obtained periprocedural by UltraTrac and cardiac output measurements obtained by thermodilution and/or direct Fick method during clinically indicated cardiac catheterization will be assessed using Bland-Altman analysis. Percentage error will be calculated as two standard deviations of the bias divided by the mean cardiac output of the two methods. A percentage error of 30% or less will be considered clinically acceptable agreement.

Time frame
Periprocedural cardiac catheterization

Secondary outcomes

1

Agreement Between UltraTrac-Derived Cardiac Output and CMR-Derived Cardiac Output

Periprocedural agreement between UltraTrac-derived and CMR-derived cardiac output (L/min) and cardiac index (L/min/m²) will be assessed using Bland-Altman analysis. CMR-derived cardiac output will be obtained during clinically indicated cardiac MRI using phase contrast flow measurement and volumetric assessment. Each participant will contribute one measurement pair per encounter, consisting of one CMR-derived cardiac output value and the temporally closest UltraTrac-derived measurement. Reported parameters will include mean bias, limits of agreement, percentage error, and 95% confidence intervals for the bias and limits of agreement. Percentage error will be calculated as 2 standard deviations of the bias divided by the mean cardiac output of the two methods × 100. Percentage error ≤30% will indicate clinically acceptable agreement by Critchley and Critchley criteria. Results will be reported overall and by age group, weight category, and cardiac anatomy.

Time frame
Periprocedural cardiac MRI encounter
2

Concordance Rate Between UltraTrac-Derived Directional Cardiac Output Changes and Clinical Hemodynamic Assessment in the CICU

The ability of UltraTrac to detect directional changes in cardiac output will be assessed during the immediate postoperative period and throughout the broader CICU admission. Measurements will be obtained during pre-defined windows before and after each clinically indicated vasoactive medication initiation or titration event. The composite clinical reference standard will include heart rate, arterial blood pressure, capillary refill time, acid-base status and lactate, and invasive hemodynamic parameters where available (arterial line, central venous pressure). Concordance between UltraTrac-derived directional cardiac output changes and composite clinical hemodynamic assessment will be reported as a concordance rate (%). The specific statistical method for concordance analysis will be determined and pre-specified prior to data collection and will be detailed in the statistical analysis plan.

Time frame
Baseline and periprocedure up to 72 hrs post procedure.
3

Percentage of Participants With Successful UltraTrac Device Placement and Analyzable Waveform Acquisition

Feasibility of UltraTrac device placement and signal acquisition will be assessed as the proportion of enrolled participants with successful device placement and analyzable waveform data acquisition across the cardiac catheterization laboratory, cardiac MRI suite, and cardiac intensive care unit settings.

Time frame
Baseline and periprocedural
4

Time Required for UltraTrac Device Application

Time required for UltraTrac device application will be recorded by study personnel during the specific clinical setting in which the device is applied.

Time frame
Baseline and periprocedural

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

Source ClinicalTrials.gov

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