Clinical Trials Logo
  1. Home
  2. Congenital Heart Disease
  3. NCT06281639
  4. Details
NCT06281639 Clinical Trial

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

Congenital Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06281639
Other study ID # RAPID
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2024
Est. completion date April 1, 2025

Study information
Verified date April 2024
Source University of Minnesota
Contact Gwenyth Fischer, MD
Phone 6126256678
Email fisch662@umn.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date April 1, 2025
Est. primary completion date April 1, 2025
Accepts healthy volunteers
Gender All
Age group N/A to 1 Year
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT04992793 - Paediatric Brain Injury Following Cardiac Interventions
Recruiting NCT05213598 - Fontan Associated Liver Disease and the Evaluation of Biomarkers for Disease Severity Assessment
Completed NCT04136379 - Comparison of Home and Standard Clinic Monitoring of INR in Patients With CHD
Completed NCT04814888 - 3D Airway Model for Pediatric Patients
Recruiting NCT04920643 - High-exchange ULTrafiltration to Enhance Recovery After Pediatric Cardiac Surgery N/A
Completed NCT05934578 - Lymphatic Function in Patients With Fontan Circulation: Effect of Physical Training N/A
Recruiting NCT06041685 - Effect of Local Warming for Arterial Catheterization in Pediatric Anesthesia N/A
Recruiting NCT05902013 - Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation N/A
Not yet recruiting NCT05687292 - Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery
Not yet recruiting NCT05524324 - Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: RIGHT-CRT N/A
Completed NCT02746029 - Cardiac Murmurs in Children: Predictive Value of Cardiac Markers
Completed NCT02537392 - Multi-micronutrient Supplementation During Peri-conception and Congenital Heart Disease N/A
Completed NCT03119090 - Fontan Imaging Biomarkers (FIB) Study
Recruiting NCT02258724 - Swiss National Registry of Grown up Congenital Heart Disease Patients
Terminated NCT02046135 - Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery Phase 2
Completed NCT01966237 - Milrinone Pharmacokinetics and Acute Kidney Injury
Recruiting NCT01184404 - Bosentan Improves Clinical Outcome of Adults With Congenital Heart Disease or Mitral Valve Lesions Who Undergo CArdiac Surgery N/A
Completed NCT01548950 - Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension N/A
Completed NCT01821287 - Nutritional Failure in Infants With Single Ventricle Congenital Heart Disease N/A