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Completed

NCT Number: NCT05162599

Evaluation of Cardiags Trimod for Analysis of Cardiac Activity

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.

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Key information

Conditions

Murmur, Heart Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Heart Murmurs Pathologic Processes Pathological Conditions, Signs and Symptoms Rhythm; Abnormal Signs and Symptoms

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital de Fourvière

Lyon, 69005, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Diagnostic study, experimental evaluative cross-sectional study

Device

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

Other names: Noinvasive multisensors cardiac examination

Primary outcomes

  1. Murmurs detection

    Time frame: 15 minutes

    Evaluate the performance of Cardiags Trimod compared to a reference examination, echocardiography, for the detection of murmurs: Presence/Absence

  2. Heart rhythm disorders

    Time frame: 15 minutes

    Abnormal and irregular heart rhythm

Secondary outcomes

  1. Accuracy of cardiac intervals measures

    Time frame: 15 minutes

    Measures accuracy

  2. Reproductibilty of measurements

    Time frame: 15 minutes

    Repetition of three measurements by the same operator

  3. Security and usability

    Time frame: 1 year

    collection of problems and incidents during clinical study

  4. Acceptability

    Time frame: 1 year

    satisfaction survey

Sponsors and collaborators

Lead sponsor

CARDIAGS

Industry

Registry information

Official study title

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

Acronym: EVALTRIMOD

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 17, 2021
Registry last updated
Jan 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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