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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
120
This is a cross-sectional diagnostic study with collection of information from the gold standard (or reference test) and the new device
Hôpital de Fourvière
Lyon, France
Murmurs detection
Evaluate the performance of Cardiags Trimod compared to a reference examination, echocardiography, for the detection of murmurs: Presence/Absence
Time frame: 15 minutes
Heart rhythm disorders
Abnormal and irregular heart rhythm
Time frame: 15 minutes
Accuracy of cardiac intervals measures
Measures accuracy
Time frame: 15 minutes
Reproductibilty of measurements
Repetition of three measurements by the same operator
Time frame: 15 minutes
Security and usability
collection of problems and incidents during clinical study
Time frame: 1 year
Acceptability
satisfaction survey
Time frame: 1 year
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