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

Not Applicable

Recruiting

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

• Registration Number: NCT06717373
• Lead Sponsor: Caption Health, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2024-07-19
• Study First Submitted QC: 2024-12-03
• Study First Posted: 2024-12-05
• Status Verified: 2025-02
• Study Start: 2025-02-07
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients scheduled for an echocardiographic examination
• Patients ≥18 years old
• Patient with known or suspected valve disease based on medical history

Exclusion Criteria

• Patients with artificial aortic valves
• Unable to lie flat for study
• Patients experiencing a known or suspected acute cardiac event
• Patients unwilling or unable to give written informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity	At the time of the examination	The primary endpoints are the sensitivity and specificity of the Caption AutoAS algorithm for the absence (none/mild AS) or presence (moderate/severe AS) of AS relative to that indicated in the echocardiographic examination.

Secondary Outcome Measures

Name	Time	Method
Subgroup analysis of outcome 1	At the time of the examination	Subgroup Analyses: Sensitivity and specificity will be calculated for the following sub-groups. BMI group (\< 25, ≥ 25-30, ≥ 30), sex, and age (\<65, ≥65)

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States