Evaluation of Cardiags Trimod for Analysis of Cardiac Activity

NCT ID: NCT05162599

Last Updated: 2024-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-08

Study Completion Date

2023-06-08

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.

Conditions

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Murmur, Heart Rhythm; Abnormal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a cross-sectional diagnostic study with collection of information from the gold standard (or reference tests) and the new device
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic study, experimental evaluative cross-sectional study

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

Group Type EXPERIMENTAL

Diagnostic study, experimental evaluative cross-sectional study

Intervention Type DEVICE

This is a cross-sectional diagnostic study with collection of information from the gold standard (or reference test) and the new device

Interventions

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Diagnostic study, experimental evaluative cross-sectional study

This is a cross-sectional diagnostic study with collection of information from the gold standard (or reference test) and the new device

Intervention Type DEVICE

Other Intervention Names

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Noinvasive multisensors cardiac examination

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,
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CARDIAGS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurent Mr Boisson, Dr

Role: PRINCIPAL_INVESTIGATOR

Hopital Fourvière Lyon France

Bernard Mr RITZ, Dr

Role: PRINCIPAL_INVESTIGATOR

Hopital Fourvière Lyon France

Locations

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Hôpital de Fourvière

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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CDGS-EC-01

Identifier Type: -

Identifier Source: org_study_id

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