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

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

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.

Study Overview

• Status: Completed
• Conditions: Rhythm; Abnormal; Murmur, Heart
• Intervention / Treatment: Device: Diagnostic study, experimental evaluative cross-sectional study

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nacira MS ZEGADI, Dr Ing; Phone Number: +33630615355931; Email: nzegadi@cardiags.com
• Study Contact Backup: Name: Lucie MS RIBAULT, DR; Phone Number: +33472573321; Email: lucie.ribault@hopital-fourviere.fr

Study Locations

• France
  • Lyon, France, 69005
    • Hôpital de Fourvière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Device: 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 Names: Noinvasive multisensors cardiac examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of cardiac intervals measures	Measures accuracy	15 minutes
Reproductibilty of measurements	Repetition of three measurements by the same operator	15 minutes
Security and usability	collection of problems and incidents during clinical study	1 year
Acceptability	satisfaction survey	1 year

Collaborators and Investigators

• Sponsor: CARDIAGS
• Investigators: Principal Investigator: Laurent Mr Boisson, Dr, Hopital Fourvière Lyon France; Principal Investigator: Bernard Mr RITZ, Dr, Hopital Fourvière Lyon France

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2022
• Primary Completion (Actual): June 8, 2023
• Study Completion (Actual): June 8, 2023

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: December 6, 2021
• First Posted (Actual): December 17, 2021

Study Record Updates

• Last Update Posted (Actual): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Electrocardiogram; Sensors; Heart sounds; Medical examination device; Connected cardiac auscultation; Heartbeat; Pulse wave; Pathological heart sounds
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Murmurs
• Other Study ID Numbers: CDGS-EC-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No