RAPID: a Comparison Study of a Novel Ultrasound Device of Automated Congenital Heart Imaging

NCT06281639 | Completed FDA Device

• 1 other identifier: PEDS-2023-32532
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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

  30minutes

Study Arms (1)

study group

Caregivers who have a child with a scheduled Pediatric congenital ultrasound (PCU) the day of recruitment

Device: RAPID

Interventions

RAPID DEVICE

test the clinical screening potential for congenital heart disorders using a single ECHO image taken by the RAPID device

study group

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

children with a scheduled PCU the day of recruitment

You may qualify if:

• \<1 years old
• Be a patient at Masonic Children's Hospital or Masonic Children's Heart Center clinic undergoing PCU

You may not qualify if:

• Open Chest
• On ECMO
• Deemed medically unstable by care team
• Cardiology, ICU, hospitalist or bedside nurse concerns

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Gwenyth Fischer, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 28, 2024
• Study Start: July 21, 2024
• Primary Completion: August 28, 2025
• Study Completion: August 28, 2025
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

US (1)