Congenital Heart Disease
Conditions
Brief 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.
Interventions
DEVICEDevice-Aided performances
Determination of the presence of the 8 findings suspicious of CHD by readers, aided by the device
OTHERDevice-Unaided performances
Determination of the presence of the 8 findings suspicious of CHD by readers, unaided by the device
Sponsors
BrightHeart
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC of the ROC curve for the presence of any suspicious finding | 1 month | AUC of the ROC curve for both reading conditions (aided vs unaided by the device) derived from the identification of any suspicious radiographic finding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC of the ROC curve for the presence of each suspicious finding | 1 month | AUCs of the ROC curve for both reading conditions (aided vs unaided by the device) for identification of each finding. |
| Sensitivity and specificity for both reading conditions for the presence of any suspicious finding | 1 month | Sensitivity and specificity for both reading conditions (aided vs unaided by the device) for identification of each finding. |
| Sensitivity and specificity for both reading conditions for the presence of each suspicious finding | 1 month | Sensitivity and specificity for both reading conditions for the presence of each suspicious finding. |
Countries
United States
Outcome results
None listed