NCT06717373

Point-of-Care Echocardiography in Patients with Known or Suspected Aortic Stenosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Caption Health, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective clinical trial intended to capture echocardiographic images in patients clinically indicated for an echocardiographic examination using an additional Point of Care Ultrasound device . The images collected will be used to test and possibly validation an AI base Aortic Valve Stenosis algorithm

Detailed description

This is a non-randomized, un-blinded single-arm study in patients scheduled for a standard echocardiographic examination. Participants will be scanned by a sonographer (Study Exam) and 6 standard views will be obtained using both the ultrasound systems: PLAX, PSAX-AV, AP4, AP2, AP3 and AP5 . The patient will undergo their scheduled echocardiographic examination either before or after the study examinations. The findings from the clinically indicated echocardiographic examination will be used as a gold standard for the presence/absence and severity of aortic stenosis. The first 45 patients, 15 with mild, 15 with moderate and 15 with severe AS, will be used for testing and possible fine-tuning the AutoAS algorithm for each Study Device, and the remaining up to 155 patients for each Study Device will be used for clinical validation of the algorithm. Because these first 45 patients will only be used for possible fine-tuning the AutoAS algorithm, they will be excluded from endpoint analysis.

Conditions

• Patients with an Indication for an Echocardiographic Examination with Suspicion of Valcular Heart Disease

Interventions

Type	Name	Description
DEVICE	AutoAS	AutoAS is an artificial intelligence algorithm that will be tested retrospectively on the images acquired as part of the study

Timeline

• Start date: 2025-02-07
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2024-12-05
• Last updated: 2025-02-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study