Congenital Heart DiseaseNCT06171698
Impedance During Cardiac Catheterization to Build a Non-Invasive Cardiac Output Algorithm
A study testing Research Prototype Monitor in people with Congenital Heart Disease, run by Johns Hopkins University at 1 site in United States.
Trial summary
Prospectively measure impedance during cardiac catheterization to build a cardiac output algorithm. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Research Prototype Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2023to 24 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Scheduled to undergo cardiac catheterization with cardiac output measurement and Fick
- Planned to undergo general anesthesia for cardiac catheterization standard of care
- Parent/Guardian able to provide informed consent
Who cannot join
- Not planned for standard of care general anesthesia for cardiac catheterization
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Children's Center
Baltimore, Maryland, 21287
About this study
Official title: Prospective Measurement of Impedance During Cardiac Catheterization to Build a Non-Invasive Cardiac Output Algorithm
Prospectively measure impedance during cardiac catheterization to build a cardiac output algorithm.
- Conditions
- Congenital Heart Disease
- Being tested
- Research Prototype Monitor
- 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.
Research Prototype MonitorDevice
Continuous vital sign is collected via a research prototype monitor
| Study group | Role | What they receive |
|---|---|---|
| Research Prototype Monitor | Experimental | Not described Receives: Device: Research Prototype Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of a non-invasive monitoring device
Feasibility of a non-invasive monitoring device that can accurately measure cardiac output in patients with congenital heart disease as determined by percent error compared to catheter-measured cardiac output.
Measured: From device placement to removal, up to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start30 Mar 2023
- Primary completion24 Jun 2025
- Study completion24 Jun 2025
Why it stopped: Closed at site. Investigator no longer at location.
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 Johns Hopkins UniversityThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danielle Gottlieb Sen, MD, MPH, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171698
- Sponsor's protocol ID
- IRB00281586
- Status last verified
- Jul 2025
- First submitted
- 28 Nov 2023
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Measurement of Impedance During Cardiac Catheterization to Build a Non-Invasive Cardiac Output Algorithm
- ClinicalTrials.gov ID
- NCT06171698
- Acronym / sponsor ID
- IRB00281586
- Conditions
- Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Closed at site. Investigator no longer at location.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 24 Jun 2025 (actual)
- Study completion
- 24 Jun 2025 (actual)
- First posted
- 15 Dec 2023 (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.
Prospectively measure impedance during cardiac catheterization to build a cardiac output algorithm.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Research Prototype Monitor | Experimental | Device: Research Prototype Monitor |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Scheduled to undergo cardiac catheterization with cardiac output measurement and Fick
- Planned to undergo general anesthesia for cardiac catheterization standard of care
- Parent/Guardian able to provide informed consent
Key exclusion criteria (1 listed)
- Not planned for standard of care general anesthesia for cardiac catheterization
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 |
|---|---|---|
| Research Prototype MonitorContinuous vital sign is collected via a research prototype monitor | Device | Research Prototype Monitor |
Primary outcome
Feasibility of a non-invasive monitoring device
Time frame: From device placement to removal, up to 12 hours
Feasibility of a non-invasive monitoring device that can accurately measure cardiac output in patients with congenital heart disease as determined by percent error compared to catheter-measured cardiac output.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- 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. This study is not recruiting at the moment.
Danielle Gottlieb Sen, MD, MPH principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Research Prototype Monitor in people with Congenital Heart Disease, run by Johns Hopkins University 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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 14 Jul 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of a non-invasive monitoring device (time frame: From device placement to removal, up to 12 hours). 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 14 Jul 2025.