Assessment of the Vivio System as an Aid in the Identification of Heart Sounds Associated With Severe Aortic Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Avicena LLC
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Primary Endpoint - Sensitivity and specificity of detection of heart sounds associated with severe aortic stenosis by the Vivio System
研究概览
简要总结
Evaluate the sensitivity and specificity of the Vivio System when used as an aid in the identification of heart sounds associated with severe aortic stenosis.
详细描述
Prospective, non-randomized, multi-center study of adult subjects referred for echocardiography. Total of 200 enrolled subjects at 3 sites. Up to 10 roll-in subjects per site. Enrolled subjects will undergo: Vivio data capture, Eko stethoscope capture of heart sounds, Standard of care transthoracic echocardiogram (TTE). Vivio analysis will not be available to non-Avicena personnel. Recorded sounds from the FDA-approved Eko stethoscope will be presented to an independent expert physician review panel blinded to Vivio and TTE results, to compare diagnosis of severe AS using Eko (auscultation) vs. Vivio (algorithms).
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult subjects (21 years of age or older).
- •Referred for transthoracic echocardiography by physician/primary care provider/cardiologist.
- •Willing and able to participate in all study evaluations and allow access to medical testing and records.
- •Signed informed consent or have a legally authorized representative who provides informed consent on behalf of the subject.
排除标准
- •Acute coronary syndrome, cardiogenic shock or the need for inotropic/mechanical circulatory support.
- •Need for bedside echocardiogram (inpatient).
- •Prosthetic device previously implanted at aortic valve position.
- •Inability to palpate carotid pulse (e.g. due to severe obesity)
- •History of carotid sinus hypersensitivity (i.e. fainting in response to touching or positioning the neck).
- •History of carotid artery disease or treatment (e.g. unstable carotid plaques that might rupture upon massage or endarterectomy).
- •Open skin lesions at target site of electronic stethoscope/Vivio device examination.
结局指标
主要结局
Primary Endpoint - Sensitivity and specificity of detection of heart sounds associated with severe aortic stenosis by the Vivio System
时间窗: 48 Hours
Sensitivity and specificity of detection of heart sounds associated with severe aortic stenosis by the Vivio System compared to the Expert Physician Panel (EPP).
次要结局
- Secondary Endpoint 1 - Sensitivity and specificity relative to PCPP detection of heart sounds associated with severe aortic stenosis.(48 Hours)
- Secondary Endpoint 2 - Correlation of Vivio results to transthoracic echocardiography assessment of aortic stenosis as determined by echocardiography.(48 Hours)
- Secondary Endpoint 3 - Additional analysis of data to include Likelihood Ratios (LR), Positive Predictive Value (PPV), and Negative Predictive Value (NPV).(48 Hours)
- Secondary Endpoint 4 - Assessment of type and degree of all heart sounds associated with aortic stenosis (mild/moderate/severe).(48 Hours)