Evaluation of Cardiags Trimod for Analysis of Cardiac Activity

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Murmur, Heart, Rhythm; Abnormal

Intervention / Treatment
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* Device: Diagnostic study, experimental evaluative cross-sectional study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persons suitable for receiving an echocardiogram and an electrocardiogram, People who signed the consent form, Exclusion Criteria: Protected and vulnerable people, People refusing to participate in the study,

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: This is a cross-sectional diagnostic study with collection of information from the gold standard (or reference tests) and the new device
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic study, experimental evaluative cross-sectional study<br>Evaluate the performance of the Cardiags Trimod medical device, compared to a reference examination, echocardiography, for the detection of heart murmurs Verification of the performance of the Cardiags Trimod medical device compared to a reference examination (ECG, Cardiologist interpretation) for the detection of rythm abnormalities Verification of the repeatability of measurements Verification of safety and suitability for use Verification of acceptability | Device: Diagnostic study, experimental evaluative cross-sectional study<br>* This is a cross-sectional diagnostic study with collection of information from the gold standard (or reference test) and the new device<br>* Other names: Noinvasive multisensors cardiac examination;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Murmurs detection | Evaluate the performance of Cardiags Trimod compared to a reference examination, echocardiography, for the detection of murmurs: Presence/Absence | 15 minutes | 
| Heart rhythm disorders | Abnormal and irregular heart rhythm | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of cardiac intervals measures | Measures accuracy | 15 minutes | 
| Reproductibilty of measurements | Repetition of three measurements by the same operator | 15 minutes | 
| Security and usability | collection of problems and incidents during clinical study | 1 year | 
| Acceptability | satisfaction survey | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sensors, Medical examination device, Connected cardiac auscultation, Heartbeat, Heart sounds, Pulse wave, Electrocardiogram, Pathological heart sounds