Evaluation of Cardiags Trimod for Analysis of Cardiac Activity
NCT ID: NCT05162599
Last Updated: 2024-01-25
Study Results
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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COMPLETED
NA
120 participants
INTERVENTIONAL
2022-06-08
2023-06-08
Brief Summary
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Detailed Description
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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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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
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
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* People who signed the consent form,
Exclusion Criteria
* People refusing to participate in the study,
6 Years
ALL
Yes
Sponsors
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CARDIAGS
INDUSTRY
Responsible Party
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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
Countries
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Other Identifiers
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CDGS-EC-01
Identifier Type: -
Identifier Source: org_study_id
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