NCT05673174已完成不适用
Assessment of the Vivio System for the Non-Invasive Estimation of Left Ventricular Diastolic Pressure (LVDP) in Healthy Volunteers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Avicena LLC
- 入组人数
- 321
- 试验地点
- 1
- 主要终点
- To construct an algorithm from training data set to be used to estimate the ROC curve from the algorithm for a separate test data set.
研究概览
简要总结
The purpose of this study is to document the utility of the Vivio System in quantifying LVDP in healthy volunteers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 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.
- •No known significant health problems.
- •Willing and able to participate in all study evaluations.
- •Ability to understand and sign informed consent.
排除标准
- •Open skin lesions at the site of Vivio application / examination.
- •Inability to obtain brachial artery blood pressure.
结局指标
主要结局
To construct an algorithm from training data set to be used to estimate the ROC curve from the algorithm for a separate test data set.
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
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