Congenital Heart DiseaseUltraTracNCT07866573
UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
A study testing UltraTrac in people with Congenital Heart Disease and Cardiac Output, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 80 years
- Conditions the study is for
- Congenital Heart Disease, Cardiac Output, Hemodynamic Monitoring
- What is being tested?
- UltraTrac
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
- For Arm 1: scheduled to undergo hemodynamic cardiac catheterization during which thermodilution and/or direct Fick cardiac output measurements will be performed as part of standard clinical care
- For Arm 2: scheduled to undergo cardiac MRI during which CMR-derived cardiac output measurement will be obtained as part of the clinical protocol
- For Arm 3: admitted to the cardiac intensive care unit and anticipated to require initiation or titration of vasoactive medication as part of standard clinical management
- Parental permission, and assent when applicable, obtained from at least one parent or legally authorized representative
Who cannot join
- 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
- Participant or family refusal to participate or inability to obtain informed consent or parental permission
- Pregnant women/persons
Show all 12Show fewer
- Fetuses
- Prisoners
- Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent
- Employees of the researcher
- Students of the researcher
- Active members of the military or DoD personnel
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
M Health Fairview University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, 55454
Juan Carlos Samayoa, samay008@umn.edu
About this study
Official title: UltraTrac for Noninvasive Cardiac Output Monitoring in Patients With Congenital Heart Disease: A Multi-Setting Pilot Feasibility Study
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.
Read the detailed description
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.
- Being tested
- UltraTrac
- Keywords
- Congenital heart disease, UltraTrac, CHD, Wearable device, Carotid Doppler ultrasound
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltraTracDevice
Also called UltraTrac Wearable Hemodynamic Monitoring 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 group | Role | What they receive |
|---|---|---|
| Cardiac Catheterization Laboratory UltraTrac Monitoring | Experimental | 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. Receives: Device: UltraTrac |
| Cardiac MRI UltraTrac Monitoring | Experimental | 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. Receives: Device: UltraTrac |
| Cardiac Intensive Care Unit UltraTrac Monitoring | Experimental | 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. Receives: Device: UltraTrac |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Periprocedural cardiac catheterization
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion30 Nov 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan Carlos Samayoa, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866573
- Sponsor's protocol ID
- PEDS-2026-34943
- Other IDs
- STUDY00028830
- Acronym
- UltraTrac
- Status last verified
- Nov 2026
- First submitted
- 9 Sep 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UltraTrac for Noninvasive Cardiac Output Monitoring in Patients With Congenital Heart Disease: A Multi-Setting Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT07866573
- Acronym / sponsor ID
- UltraTrac / PEDS-2026-34943
- Keywords
- Congenital heart disease, UltraTrac, CHD, Wearable device, Carotid Doppler ultrasound
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cardiac Catheterization Laboratory UltraTrac Monitoring | Experimental | Device: UltraTracParticipants 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. |
| Cardiac MRI UltraTrac Monitoring | Experimental | Device: UltraTracParticipants 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. |
| Cardiac Intensive Care Unit UltraTrac Monitoring | Experimental | Device: UltraTracParticipants 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. |
Who may qualify
- Ages
- 0 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- For Arm 1: scheduled to undergo hemodynamic cardiac catheterization during which thermodilution and/or direct Fick cardiac output measurements will be performed as part of standard clinical care
Key exclusion criteria (12 listed)
- 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
- Participant or family refusal to participate or inability to obtain informed consent or parental permission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltraTracAlso: UltraTrac Wearable Hemodynamic Monitoring DeviceUltraTrac 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. | Device | Cardiac Catheterization Laboratory UltraTrac Monitoring, Cardiac Intensive Care Unit UltraTrac Monitoring, Cardiac MRI UltraTrac Monitoring |
Primary outcome
Agreement Between UltraTrac-Derived Cardiac Output and Reference Standard Cardiac Output During Cardiac Catheterization
Time frame: Periprocedural 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.
6 secondary outcomes
Agreement Between UltraTrac-Derived Cardiac Output and CMR-Derived Cardiac Output
Time frame: Periprocedural cardiac MRI encounter
Concordance Rate Between UltraTrac-Derived Directional Cardiac Output Changes and Clinical Hemodynamic Assessment in the CICU
Time frame: Baseline and periprocedure up to 72 hrs post procedure.
Percentage of Participants With Successful UltraTrac Device Placement and Analyzable Waveform Acquisition
Time frame: Baseline and periprocedural
Time Required for UltraTrac Device Application
Time frame: Baseline and periprocedural
UltraTrac Tolerability and Comfort Questionnaire Score
Time frame: Baseline and periprocedural
UltraTrac Waveform Signal Quality Scale Score
Time frame: Baseline and periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juan Carlos Samayoa principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UltraTrac in people with Congenital Heart Disease and Cardiac Output, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brittany Faanes (612-625-5929, grego318@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement Between UltraTrac-Derived Cardiac Output and Reference Standard Cardiac Output During Cardiac Catheterization (time frame: Periprocedural cardiac catheterization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.