NCT05140642

Safety and Efficacy Study of AI LVEF

Blinded Randomized Controlled Trial of Artificial Intelligence Guided Assessment of Cardiac Function

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,495 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

Summary

To determine whether an integrated AI decision support can save time and improve accuracy of assessment of echocardiograms, the investigators are conducting a blinded, randomized controlled study of AI guided measurements of left ventricular ejection fraction compared to sonographer measurements in preliminary readings of echocardiograms.

Conditions

• Heart Failure, Systolic
• Heart Failure, Diastolic

Interventions

Type	Name	Description
OTHER	Automated annotation of the left ventricle through deep learning	A semantic segmentation deep learning model will identify the left ventricle and label the left ventricle. The AI model will produce an assessment of LVEF using video based features.
OTHER	Sonographer Measurement of LVEF	Standard practice sonographer measurement of left ventricle and assessment of LVEF

Timeline

• Start date: 2022-04-01
• Primary completion: 2022-06-29
• Completion: 2022-06-29
• First posted: 2021-12-01
• Last updated: 2022-07-05

Locations

1 site across 1 country: United States