跳至主要内容
临床试验/NCT05162599
NCT05162599已完成不适用

Evaluation of Cardiags Trimod, a New Medical Device for Screening Cardiac Abnormalities

CARDIAGS2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年6月8日最近更新:
适应症

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

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)

研究者

发起方
CARDIAGS
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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