An interventional study of UltraTrac in Congenital Heart Disease, Cardiac Output and Hemodynamic Monitoring, sponsored by University of Minnesota. Not yet recruiting at 1 site in United States. Open to participants aged 0 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by University of Minnesota · Not applicable, Interventional, and Diagnostic
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.
Accurate continuous hemodynamic monitoring is important in the management of pediatric and neonatal patients with congenital heart disease, but current monitoring methods may be invasive, intermittent, operator-dependent, or difficult to apply in small pediatric patients.
UltraTrac is an investigational wearable hemodynamic monitoring device that integrates impedance cardiography and carotid Doppler ultrasound into a single noninvasive platform. The device uses surface electrodes on the thorax and a wearable Doppler probe positioned over the carotid artery. No vascular access, ionizing radiation, or invasive procedure is required for device application or operation.
This prospective, single-center, pilot feasibility study will evaluate the accuracy and feasibility of UltraTrac for noninvasive cardiac output monitoring in patients with congenital heart disease across three clinical settings: the cardiac catheterization laboratory, the cardiac MRI suite, and the cardiac intensive care unit.
In the cardiac catheterization laboratory arm, UltraTrac cardiac output measurements will be compared with thermodilution and/or direct Fick cardiac output measurements obtained during clinically indicated cardiac catheterization. In the cardiac MRI arm, UltraTrac measurements will be compared with cardiac MRI-derived cardiac output measurements obtained as part of clinically indicated imaging. In the cardiac intensive care unit arm, UltraTrac will be used to assess directional changes in cardiac output before and after clinically indicated introduction or titration of vasoactive medications.
UltraTrac measurements will not be used to guide clinical care. All clinical decisions will remain the responsibility of the treating clinical team, and UltraTrac data will be analyzed offline after data collection.
1,007 studies on the registry are indexed under Heart Defects, Congenital; 257 are open to participants now.
This study's planned enrollment of 70 is above the median of 60 across 524 interventional studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →University of Minnesota is the lead sponsor of 1,185 studies on the registry; 196 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 92 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: UltraTrac
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.
Device: UltraTrac
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.
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.
Also known as: UltraTrac Wearable Hemodynamic Monitoring Device
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
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
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.
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
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
UltraTrac Tolerability and Comfort Questionnaire Score
Comfort and tolerability of device application will be assessed using the UltraTrac Tolerability and Comfort Questionnaire, a standardized instrument developed and defined prospectively by the study team prior to data collection. The questionnaire uses a 5-point rating scale ranging from 1 (minimum, very uncomfortable or intolerable) to 5 (maximum, completely comfortable and well tolerated), where higher scores indicate a better outcome. The questionnaire will be administered to the participant, caregiver, or both at the time of device removal following each study encounter. Mean scores and standard deviations will be reported for the overall cohort and stratified by age group, clinical setting, and device application duration.
Time frame: Baseline and periprocedural
UltraTrac Waveform Signal Quality Scale Score
Signal quality will be assessed using the UltraTrac Waveform Signal Quality Scale, a standardized 5-point rating scale ranging from 1 (minimum, uninterpretable waveform) to 5 (maximum, optimal waveform quality), where higher scores indicate a better outcome. This scale was developed and defined prospectively by the study team prior to data collection. Scores will be assigned independently to ICG and carotid Doppler waveform acquisitions by two blinded reviewers. Mean scores and standard deviations will be reported for the overall cohort and across the following pre-specified subgroups: age (neonates 0-30 days, infants 31 days-12 months, children 1-12 years, adolescents and young adults 13-21 years, and adults 22 years and older), weight (\<3 kg, 3-10 kg, 10-20 kg, \>20 kg), and cardiac anatomy (single ventricle vs. biventricular). Inter-rater agreement will be reported using intraclass correlation coefficient.
Time frame: Baseline and periprocedural
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Minnesota