Optimization of the Vivio System Algorithm 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
- 撤回
- 发起方
- Avicena LLC
- 试验地点
- 2
- 主要终点
- Primary Endpoint - Generation of an optimized algorithm that can be used to develop an algorithm for use as an aid in the identification of heart sounds associated with severe aortic stenosis.
研究概览
简要总结
Optimize a candidate software algorithm using data collected with the Vivio system for use as an aid in the identification of heart sounds associated with severe aortic stenosis
详细描述
Prospective, non-randomized, single-center study of adult subjects referred for echocardiography. Total of 200 enrolled subjects at 1 site
Enrolled subjects will undergo:
Vivio system data capture, standard of care transthoracic echocardiogram (TTE). Vivio analysis will not be available to non-Avicena personnel
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
盲法说明
No masking required
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.
- •Ability to understand and sign an informed consent or have a legally authorized representative to provide 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
- •History of carotid sinus hypersensitivity (i.e. fainting in response to touching or positioning the neck).
- •History of significant carotid artery disease or treatment (surgery, stenting, > 50% stenosis in both left and right carotid artery).
- •Open skin lesions at target site of Vivio examination.
结局指标
主要结局
Primary Endpoint - Generation of an optimized algorithm that can be used to develop an algorithm for use as an aid in the identification of heart sounds associated with severe aortic stenosis.
时间窗: 48 hours
Generation of an optimized algorithm that can be used to develop an algorithm for use as an aid in the identification of heart sounds associated with severe aortic stenosis.
次要结局
- Secondary Endpoint - Incidence of Adverse Events: Summary of all reported adverse events during the study(48 hours)