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

Recruiting

• Conditions: Congenital Heart Disease
• Interventions: Device: RAPID

• Registration Number: NCT06281639
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-19
• Study First Submitted QC: 2024-02-19
• Study First Posted: 2024-02-28
• Study Start: 2024-07-21
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-08
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
study group	RAPID	Caregivers who have a child with a scheduled Pediatric congenital ultrasound (PCU) the day of recruitment

Primary Outcome Measures

Name	Time	Method
RAPID imaging quality	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

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States