Congenital Heart DiseaseNCT06281639
RAPID: a Comparison Study of a Novel Ultrasound Device of Automated Congenital Heart Imaging
An observational study of Congenital Heart Disease, run by University of Minnesota at 1 site in United States.
Trial summary
The RAPID ultrasound is a portable imaging device that captures a one point image from the subcostal region of the heart. The device is set on the patient's chest and captures the image in \<1 minute. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- RAPID
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2024to 28 Aug 2025
- Phase
- Observational
- 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 1 year
- All sexes
- Child
Study population: children with a scheduled PCU the day of recruitment
Who may be able to join
- <1 years old
- Be a patient at Masonic Children's Hospital or Masonic Children's Heart Center clinic undergoing PCU
Who cannot join
- Open Chest
- On ECMO
- Deemed medically unstable by care team
- Cardiology, ICU, hospitalist or bedside nurse concerns
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
The RAPID ultrasound is a portable imaging device that captures a one point image from the subcostal region of the heart. The device is set on the patient's chest and captures the image in \<1 minute. It uses ultrasound imaging energy that is similar to commercialized devices and safe for patients of all ages and sizes. The device is a non-significant risk and therefore will not require an IDE. Images from RAPID will be taken directly before or after the standard clinical PCU. Images taken from both the RAPID device and the standard PCU will be de-identified and stored securely in BOX for review by two independent cardiologists. Image reviews will be conducted within Box.
- Conditions
- Congenital Heart Disease
- Being tested
- RAPID
- 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.
RAPIDDevice
test the clinical screening potential for congenital heart disorders using a single ECHO image taken by the RAPID device
| Study group | Role | What they receive |
|---|---|---|
| study group | Caregivers who have a child with a scheduled Pediatric congenital ultrasound (PCU) the day of recruitment Receives: Device: RAPID |
What is being measured
The primary outcome is the main question the study is designed to answer.
RAPID imaging quality
comparing the result of the data and imaging collected from the gold standard (PCU) vs the prototype device (RAPID)
Two independent cardiologists will review each de-identified image in a large batch of standardized images consisting of random images from both RAPID and PCU. Each image will be reviewed by the cardiologists based on a specific checklist
Measured: 30minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start21 Jul 2024
- Primary completion28 Aug 2025
- Study completion28 Aug 2025
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gwenyth Fischer, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281639
- Sponsor's protocol ID
- PEDS-2023-32532
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2024
- Last updated
- 23 Feb 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 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAPID: a Comparison Study of a Novel Ultrasound Device of Automated Congenital Heart Imaging
- ClinicalTrials.gov ID
- NCT06281639
- Acronym / sponsor ID
- PEDS-2023-32532
- Conditions
- Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 21 Jul 2024 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 28 Feb 2024 (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.
The RAPID ultrasound is a portable imaging device that captures a one point image from the subcostal region of the heart. The device is set on the patient's chest and captures the image in \<1 minute. It uses ultrasound imaging energy that is similar to commercialized devices and safe for patients of all ages and sizes. The device is a non-significant risk and therefore will not require an IDE. Images from RAPID will be taken directly before or after the standard clinical PCU. Images taken from both the RAPID device and the standard PCU will be de-identified and stored securely in BOX for review by two independent cardiologists. Image reviews will be conducted within Box.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Device: RAPIDCaregivers who have a child with a scheduled Pediatric congenital ultrasound (PCU) the day of recruitment |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Age groups
- Child
- Study population
- children with a scheduled PCU the day of recruitment
Key inclusion criteria (2 listed)
- <1 years old
- Be a patient at Masonic Children's Hospital or Masonic Children's Heart Center clinic undergoing PCU
Key exclusion criteria (4 listed)
- Open Chest
- On ECMO
- Deemed medically unstable by care team
- Cardiology, ICU, hospitalist or bedside nurse concerns
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 |
|---|---|---|
| RAPIDtest the clinical screening potential for congenital heart disorders using a single ECHO image taken by the RAPID device | Device | study group |
Primary outcome
RAPID imaging quality
Time frame: 30minutes
comparing the result of the data and imaging collected from the gold standard (PCU) vs the prototype device (RAPID) Two independent cardiologists will review each de-identified image in a large batch of standardized images consisting of random images from both RAPID and PCU. Each image will be reviewed by the cardiologists based on a specific checklist
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 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. This study is not recruiting at the moment.
Gwenyth Fischer, MD 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?
An observational study of Congenital Heart Disease, 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 2 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: finished, as of the sponsor's last update on 23 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
RAPID imaging quality (time frame: 30minutes). 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 23 Feb 2026.