Point-of-Care Echocardiography in Patients With Known or Suspected Aortic Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Sensitivity and Specificity
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for an echocardiographic examination
- •Patients ≥18 years old
- •Patient with known or suspected valve disease based on medical history
排除标准
- •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
研究组 & 干预措施
Single Arm
There is no investigational device being used. Devices to be used are Vscan Air and Venue Ultrasound systems
干预措施: AutoAS (Device)
结局指标
主要结局
Sensitivity and Specificity
时间窗: 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.
次要结局
- Subgroup analysis of outcome 1(At the time of the examination)