Evaluation of Cardiags Trimod for Analysis of Cardiac Activity

NCT05162599 | Completed DMC

• 1 other identifier: CDGS-EC-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Murmur, Heart; Rhythm; Abnormal

Keywords

Medical examination device; Connected cardiac auscultation; Sensors; Heartbeat; Heart sounds; Pulse wave; Electrocardiogram; Pathological heart sounds

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Accuracy of cardiac intervals measures

  15 minutes

• Reproductibilty of measurements

  15 minutes

• Security and usability

  1 year

• Acceptability

  1 year

Study Arms (1)

Diagnostic study, experimental evaluative cross-sectional study

EXPERIMENTAL

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

Interventions

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

Also known as: Noinvasive multisensors cardiac examination

Diagnostic study, experimental evaluative cross-sectional study

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons suitable for receiving an echocardiogram and an electrocardiogram,
• People who signed the consent form,

You may not qualify if:

• Protected and vulnerable people,
• People refusing to participate in the study,

Sponsors & Collaborators

• CARDIAGS: lead

Study Sites (1)

Hôpital de Fourvière

Lyon, 69005, France

Location

MeSH Terms

Conditions

Heart Murmurs; Arrhythmias, Cardiac

Interventions

Diagnostic Techniques and Procedures

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Diagnosis

Study Officials

• Laurent Mr Boisson, Dr

  Hopital Fourvière Lyon France

  PRINCIPAL INVESTIGATOR

• Bernard Mr RITZ, Dr

  Hopital Fourvière Lyon France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 17, 2021
• Study Start: June 8, 2022
• Primary Completion: June 8, 2023
• Study Completion: June 8, 2023
• Last Updated: January 25, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)