NCT03751904撤回不适用
Early Feasibility Study to Assess Safety and Device Performance of AcoustiCare™
Signature Medical, Inc.0 个研究点开始时间: 2019年1月25日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
AcoustiCareTM is a non-invasive clinical tool used for the detection of intracardiac pressures using heart sounds in patients with heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects between the ages of 18 - 80 years
- •Willing and able to sign informed consent form
- •Normal subjects without a history of heart disease who are recruited from the surrounding community
- •Subjects with heart failure undergoing treatment in a hospital setting
排除标准
- •Hemodynamic instability (Systolic BP>180 or <90 and Diastolic BP>90 and <60)
- •Acute coronary syndrome
- •Prior heart transplant recipients
- •Subjects who are pacemaker dependent
- •Severe obesity (body mass index > 40 kg/m2)
- •Subjects who are pregnant
研究组 & 干预措施
AcoustiCare
Other
Single Arm
干预措施: AcoustiCare (Device)
结局指标
主要结局
Incidence of Adverse Events
时间窗: Subjects will be assessed for adverse events through study completion, an average of 1 day
The safety of the Acousticare device will be assessed by reviewing adverse events in all patients enrolled in the study
次要结局
未报告次要终点
研究者
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