Clinical Trials Logo
  1. Home
  2. Congenital Heart Disease
  3. NCT06392555
  4. Details
NCT06392555 Clinical Trial

Fetal Heart Ultrasound Suspicious Radiographic Finding Identification - Reader Study

Congenital Heart Disease Clinical Trial

Official title:
Fetal Heart Ultrasound Suspicious Radiographic Finding Identification - Reader Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06392555
Other study ID # reader2024
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 2024
Est. completion date July 2024

Study information
Verified date April 2024
Source BrightHeart
Contact Christophe Gardella, PhD
Phone +33669650566
Email christophe@brightheart.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Clinical performance of the device will be evaluated in a fully-crossed, multiple-reader multiple-case (MRMC) study. This study will be used to determine the impact of the device on reader performance in identifying suspicious radiographic findings in fetal heart ultrasound video clips recorded during 2nd trimester anatomic ultrasound examinations conducted during the second trimester of the pregnancy.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - ultrasound examinations conducted during the second trimester of the pregnancy - fetus between 18 and 24 weeks of gestational age - mothers 18 years old or older Exclusion Criteria: - exams corresponding to multiple pregnancy - fetal heterotaxy - exams not containing video clips with interpretable 4-chamber (4C), Left Ventricular Outflow Tract (LVOT) or Right Ventricular Outflow Tract (RVOT) standard views

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Device-Aided performances
Determination of the presence of the 8 findings suspicious of CHD by readers, aided by the device
Other:
• Device-Unaided performances
Determination of the presence of the 8 findings suspicious of CHD by readers, unaided by the device

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
BrightHeart

Outcome
Type Measure Description Time frame Safety issue
Primary AUC of the ROC curve for the presence of any suspicious finding AUC of the ROC curve for both reading conditions (aided vs unaided by the device) derived from the identification of any suspicious radiographic finding 1 month
Secondary AUC of the ROC curve for the presence of each suspicious finding AUCs of the ROC curve for both reading conditions (aided vs unaided by the device) for identification of each finding. 1 month
Secondary Sensitivity and specificity for both reading conditions for the presence of any suspicious finding Sensitivity and specificity for both reading conditions (aided vs unaided by the device) for identification of each finding. 1 month
Secondary Sensitivity and specificity for both reading conditions for the presence of each suspicious finding Sensitivity and specificity for both reading conditions for the presence of each suspicious finding. 1 month
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
Completed NCT01966237 - Milrinone Pharmacokinetics and Acute Kidney Injury
Terminated NCT02046135 - Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery Phase 2
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 NCT01178710 - Effect of Simvastatin on Cardiac Function N/A