Hemodynamic MonitoringULTRA-CONCT07864714
UltraTrac Clinical Pilot Study
An observational study of Hemodynamic Monitoring, run by AcQumen Medical, Inc. at 1 site in United States.
Trial summary
This single-center pilot study will evaluate the accuracy and feasibility of non-invasive cardiac output measurement using the UltraTrac device in pediatric patients aged 0-21 years undergoing standard-of-care diagnostic cardiac catheterization. Read more about this study
- Who is it for?
- Ages 0 to 21 years
- Conditions the study is for
- Hemodynamic Monitoring
- What is being tested?
- Noninvasive Hemodynamic Monitoring System
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Oct 2027
- Phase
- Observational
- 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients aged 0-21 years who are hemodynamically stable and undergoing cardiac catheterization as part of standard of care at Children's National Hospital in Washington, DC.
Who may be able to join
- Provision of signed and dated parental permission form (for patients <18) or informed consent form (for patients >= 18 years)
- Provision of verbal (for patients 7-11) or signed and dated assent form (for patients 12-17)
- Stated willingness to comply with all study procedures
- Male or female, aged 0 - 21 years
- Scheduled to undergo standard of care diagnostic cardiac catheterization at Children's National Hospital
Who cannot join
- Weight less than 2.5kg
- Patients who are hemodynamically unstable, as assessed by the attending physician
- Broken skin or poor skin integrity that would prohibit safe adhesion of electrodes or Doppler probe
- Known moderate-to-severe reactions to electrocardiogram electrode adhesives or ultrasound gel
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
Children's National Hospital
Washington D.C., District of Columbia, 20010
About this study
Official title: Clinical Pilot Study of UltraTrac-determined Cardiac Output With Standard Measures of Cardiac Output
This single-center pilot study will evaluate the accuracy and feasibility of non-invasive cardiac output measurement using the UltraTrac device in pediatric patients aged 0-21 years undergoing standard-of-care diagnostic cardiac catheterization. UltraTrac integrates ultrasound with impedance cardiography (ICG) to refine stroke volume and cardiac output calculations. During catheterization, trained staff will apply four surface-skin electrodes and a Doppler probe and obtain UltraTrac measurements without altering standard clinical care. The primary objective is to assess concordance between algorithm-derived cardiac output and gold-standard invasive measurements (Fick or thermodilution). The secondary objective is to evaluate human-factors issues reported by clinicians during device use. The study will enroll 50 hemodynamically stable pediatric participants, with up to 60 screened to account for screen failures. UltraTrac poses no more than minimal risk, using noninvasive sensors comparable to standard electrocardiogram (ECG) and Doppler procedures. Measurements will be performed only when clinically appropriate, and no UltraTrac data will be used to guide patient care.
Read the detailed description
This study is a single center, single group pilot study designed to assess the accuracy and feasibility of non invasive cardiac output measurement using the UltraTrac device in pediatric patients aged 0-21 years undergoing standard of care diagnostic cardiac catheterization. The UltraTrac system integrates ultrasound technology with a previously FDA 510(k)-cleared impedance cardiography (ICG) technology to provide noninvasive hemodynamic monitoring. Integrating the information obtained from ultrasound with ICG technology will allow for an accurate fine tuning of stroke volume measurements with an ongoing monitoring of hemodynamics.
During the catheterization procedure, trained study personnel will apply four single use surface-skin electrodes and a Doppler ultrasound probe secured with an adhesive patch. The ultrasound probe is used for audio only signal of flow in the carotid artery, and measurements will be performed only when the participant is hemodynamically stable and the standard of care procedure allows, as judged by the physician in charge. UltraTrac measurements take approximately 15 minutes including setup, and at least five cardiac output measurements will be collected for each participant.
The primary objective is to determine accuracy of algorithm derived stroke volume and cardiac output data by comparison with standard measurement methods in the cardiac catheterization laboratory (Fick measurement or thermodilution). The primary endpoint is concordance between algorithm derived measurements and standard measurements. The secondary objective is to determine human factors associated with use of the device in the clinical setting, assessed through clinician reported usability issues.
The study will enroll 50 pediatric participants, with up to 60 screened to account for screen failures. Eligible participants must be scheduled for diagnostic cardiac catheterization and be hemodynamically stable, with exclusions for weight <2.5 kg, broken skin, or moderate to severe reactions to ECG adhesives or ultrasound gel. The protocol describes UltraTrac as non significant risk, noting that it is noninvasive, not implanted, and does not pose a serious risk to the health, safety, or welfare of the subject.
Risks are limited to possible skin irritation or infection from the placement of the electrodes and the Doppler probe, and there are no known direct benefits to participants. UltraTrac measurements will not be used to inform care. All adverse events will be collected and monitored according to good clinical practices and institutional policies.
The study duration is 1 year, and participant involvement is one day, corresponding to the catheterization procedure. Data will be exported and analyzed to determine the feasibility and accuracy of UltraTrac as a noninvasive method for pediatric cardiac output assessment.
- Conditions
- Hemodynamic Monitoring
- Being tested
- Noninvasive Hemodynamic Monitoring System
- Keywords
- hemodynamics, Cardiovascular Physiology, Cardiac Output, Stroke Volume, Impedance Cardiography, Pediatric Monitoring, Ultrasonography, Doppler, Signal Processing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive Hemodynamic Monitoring SystemDevice
Also called UltraTrac, Impedance Cardiography
This study involves the use of a noninvasive hemodynamic monitoring system that integrates impedance cardiography with Doppler ultrasound to measure cardiac function. The system uses standard adhesive electrodes placed on the skin and a small ultrasound sensor positioned over the carotid artery. During each measurement period, the system collects impedance waveforms and ultrasound timing signals to estimate stroke volume, cardiac output, and left ventricular ejection time.
The UltraTrac is used only for physiologic monitoring and data collection. Study data are not used to deliver therapy, influence clinical care, or provide diagnostic information to participants or clinicians.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients indicated for diagnostic cardiac catheterization | Pediatric patients aged 0-21 years who are hemodynamically stable and undergoing cardiac catheterization as part of standard of care at Children's National Hospital in Washington, DC. Receives: Device: Noninvasive Hemodynamic Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between algorithm-derived measurements and standard measurements.
Measured: Periprocedural
Secondary outcomes (1)
Study staff and physician procedural issues captured via structured reporting form
Qualitative and quantitative documentation of issues encountered during the procedure, including number and type of issue, collected through a structured reporting form completed by study staff and physicians.
Measured: 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 startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic MonitoringStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AcQumen Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's National Research Institute
- Responsible party
- Sponsor
- Investigators
- Joshua P Kanter, MD, FACC, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864714
- Sponsor's protocol ID
- AQM-UT-002
- Other IDs
- GR001277
- Acronym
- ULTRA-CO
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pilot Study of UltraTrac-determined Cardiac Output With Standard Measures of Cardiac Output
- ClinicalTrials.gov ID
- NCT07864714
- Acronym / sponsor ID
- ULTRA-CO / AQM-UT-002
- Conditions
- Hemodynamic Monitoring
- Keywords
- hemodynamics, Cardiovascular Physiology, Cardiac Output, Stroke Volume, Impedance Cardiography, Pediatric Monitoring, Ultrasonography, Doppler, Signal Processing
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- AcQumen Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Children's National Research Institute
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (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 single-center pilot study will evaluate the accuracy and feasibility of non-invasive cardiac output measurement using the UltraTrac device in pediatric patients aged 0-21 years undergoing standard-of-care diagnostic cardiac catheterization. UltraTrac integrates ultrasound with impedance cardiography (ICG) to refine stroke volume and cardiac output calculations. During catheterization, trained staff will apply four surface-skin electrodes and a Doppler probe and obtain UltraTrac measurements without altering standard clinical care. The primary objective is to assess concordance between algorithm-derived cardiac output and gold-standard invasive measurements (Fick or thermodilution). The secondary objective is to evaluate human-factors issues reported by clinicians during device use. The study will enroll 50 hemodynamically stable pediatric participants, with up to 60 screened to account for screen failures. UltraTrac poses no more than minimal risk, using noninvasive sensors comparable to standard electrocardiogram (ECG) and Doppler procedures. Measurements will be performed only when clinically appropriate, and no UltraTrac data will be used to guide patient care.
Detailed description
This study is a single center, single group pilot study designed to assess the accuracy and feasibility of non invasive cardiac output measurement using the UltraTrac device in pediatric patients aged 0-21 years undergoing standard of care diagnostic cardiac catheterization. The UltraTrac system integrates ultrasound technology with a previously FDA 510(k)-cleared impedance cardiography (ICG) technology to provide noninvasive hemodynamic monitoring. Integrating the information obtained from ultrasound with ICG technology will allow for an accurate fine tuning of stroke volume measurements with an ongoing monitoring of hemodynamics.
During the catheterization procedure, trained study personnel will apply four single use surface-skin electrodes and a Doppler ultrasound probe secured with an adhesive patch. The ultrasound probe is used for audio only signal of flow in the carotid artery, and measurements will be performed only when the participant is hemodynamically stable and the standard of care procedure allows, as judged by the physician in charge. UltraTrac measurements take approximately 15 minutes including setup, and at least five cardiac output measurements will be collected for each participant.
The primary objective is to determine accuracy of algorithm derived stroke volume and cardiac output data by comparison with standard measurement methods in the cardiac catheterization laboratory (Fick measurement or thermodilution). The primary endpoint is concordance between algorithm derived measurements and standard measurements. The secondary objective is to determine human factors associated with use of the device in the clinical setting, assessed through clinician reported usability issues.
The study will enroll 50 pediatric participants, with up to 60 screened to account for screen failures. Eligible participants must be scheduled for diagnostic cardiac catheterization and be hemodynamically stable, with exclusions for weight <2.5 kg, broken skin, or moderate to severe reactions to ECG adhesives or ultrasound gel. The protocol describes UltraTrac as non significant risk, noting that it is noninvasive, not implanted, and does not pose a serious risk to the health, safety, or welfare of the subject.
Risks are limited to possible skin irritation or infection from the placement of the electrodes and the Doppler probe, and there are no known direct benefits to participants. UltraTrac measurements will not be used to inform care. All adverse events will be collected and monitored according to good clinical practices and institutional policies.
The study duration is 1 year, and participant involvement is one day, corresponding to the catheterization procedure. Data will be exported and analyzed to determine the feasibility and accuracy of UltraTrac as a noninvasive method for pediatric cardiac output assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients indicated for diagnostic cardiac catheterization | – | Device: Noninvasive Hemodynamic Monitoring SystemPediatric patients aged 0-21 years who are hemodynamically stable and undergoing cardiac catheterization as part of standard of care at Children's National Hospital in Washington, DC. |
Who may qualify
- Ages
- 0 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients aged 0-21 years who are hemodynamically stable and undergoing cardiac catheterization as part of standard of care at Children's National Hospital in Washington, DC.
Key inclusion criteria (5 listed)
- Provision of signed and dated parental permission form (for patients <18) or informed consent form (for patients >= 18 years)
- Provision of verbal (for patients 7-11) or signed and dated assent form (for patients 12-17)
- Stated willingness to comply with all study procedures
- Male or female, aged 0 - 21 years
- Scheduled to undergo standard of care diagnostic cardiac catheterization at Children's National Hospital
Key exclusion criteria (4 listed)
- Weight less than 2.5kg
- Patients who are hemodynamically unstable, as assessed by the attending physician
- Broken skin or poor skin integrity that would prohibit safe adhesion of electrodes or Doppler probe
- Known moderate-to-severe reactions to electrocardiogram electrode adhesives or ultrasound gel
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 |
|---|---|---|
| Noninvasive Hemodynamic Monitoring SystemAlso: UltraTrac, Impedance CardiographyThis study involves the use of a noninvasive hemodynamic monitoring system that integrates impedance cardiography with Doppler ultrasound to measure cardiac function. The system uses standard adhesive electrodes placed on the skin and a small ultrasound sensor positioned over the carotid artery. During each measurement period, the system collects impedance waveforms and ultrasound timing signals to estimate stroke volume, cardiac output, and left ventricular ejection time. The UltraTrac is used only for physiologic monitoring and data collection. Study data are not used to deliver therapy, influence clinical care, or provide diagnostic information to participants or clinicians. | Device | Pediatric patients indicated for diagnostic cardiac catheterization |
Primary outcome
Concordance between algorithm-derived measurements and standard measurements.
Time frame: Periprocedural
1 secondary outcome
Study staff and physician procedural issues captured via structured reporting form
Time frame: 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 8 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Joshua P Kanter, MD, FACC principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodynamic Monitoring, run by AcQumen Medical, Inc. 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 5 inclusion and 4 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 8 Oct 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 Dori R Jones, MSE (866-227-8636, djones@acqumenmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance between algorithm-derived measurements and standard measurements. (time frame: Periprocedural). 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 8 Oct 2026.