Evaluation of Cardiags Trimod, a New Medical Device for Screening Cardiac Abnormalities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CARDIAGS
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Heart rhythm disorders
研究概览
简要总结
The current study concerns Cardiags Trimod, a new non-invasive medical device for cardiac examinations. The evaluation of its effectiveness is done relative to specific standard devices.
详细描述
Cardiags Trimod, the subject of this study, is a new medical device for rapid and early detection of some of cardiac abnormalities, easy to use by non-cardiologists and portable wherever the patient is. Cardiags Trimod, consisting of a device and software, allows simultaneous recording, visualization and analysis in real time of signals characteristic of cardiac function. It assists healthcare professionals by measuring characteristic time intervals of cardiac function by crossing the various signals, by detecting abnormal rhythms, and murmurs.
The study aims to assess the essential requirements : the effectiveness and safety of the device. The study is a research involving the human person.Cardiags Trimod is a medical device with low risk. There is no identified risk for the patient.The patient sample tested consists of sick and healthy individuals. The use of Cardiags Trimod is part of the patient's usual consultation. The identified Gold standards are EKG and echocardiography.
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
- 6 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Persons suitable for receiving an echocardiogram and an electrocardiogram,
- •People who signed the consent form,
排除标准
- •Protected and vulnerable people,
- •People refusing to participate in the study,
结局指标
主要结局
Heart rhythm disorders
时间窗: 15 minutes
Abnormal and irregular heart rhythm
Murmurs detection
时间窗: 15 minutes
Evaluate the performance of Cardiags Trimod compared to a reference examination, echocardiography, for the detection of murmurs: Presence/Absence
次要结局
- Reproductibilty of measurements(15 minutes)
- Security and usability(1 year)
- Acceptability(1 year)
- Accuracy of cardiac intervals measures(15 minutes)
