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: Active, not recruiting

Administrative data

• NCT number: NCT06392555
• Other study ID #: reader2024
• Status: Active, not recruiting
• Start date: May 3, 2024
• Est. completion date: July 2024

Study information

• Verified date: June 2024
• Source: BrightHeart
• Contact: n/a
• Is FDA regulated: No
• 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: Active, not 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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

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
United States	MFM Associates, PLLC	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
BrightHeart

Country where clinical trial is conducted

United States, 

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