Evaluation of Cardiags Trimod for Analysis of Cardiac Activity (EVALTRIMOD)

Cardiags

Status: Completed

Conditions: Rhythm; Abnormal; Murmur, Heart

Treatments: Device: Diagnostic study, experimental evaluative cross-sectional study

Study type: Interventional

Funder types: Industry

Identifiers

NCT05162599

CDGS-EC-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 patients

Sex: All

Ages: 6+ years old

Volunteers: Accepts Healthy Volunteers

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,

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Diagnostic study, experimental evaluative cross-sectional study

Experimental group

Description:

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

Treatment:

Device: Diagnostic study, experimental evaluative cross-sectional study