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

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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

RAPID

Device

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Feb 28, 2024
Registry last updated: Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed