Evaluation of Cardiags Trimod for Analysis of Cardiac Activity

Murmur, Heart Clinical Trial

— EVALTRIMOD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05162599
• Other study ID #: CDGS-EC-01
• Status: Completed
• Phase: N/A
• Start date: June 8, 2022
• Est. completion date: June 8, 2023

Study information

• Verified date: June 2023
• Source: CARDIAGS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 8, 2023
• Est. primary completion date: June 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Heart Murmurs
• Murmur, Heart
• Rhythm; Abnormal

Intervention

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

Locations

Country	Name	City	State
France	Hôpital de Fourvière	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
CARDIAGS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Murmurs detection	Evaluate the performance of Cardiags Trimod compared to a reference examination, echocardiography, for the detection of murmurs: Presence/Absence	15 minutes
Primary	Heart rhythm disorders	Abnormal and irregular heart rhythm	15 minutes
Secondary	Accuracy of cardiac intervals measures	Measures accuracy	15 minutes
Secondary	Reproductibilty of measurements	Repetition of three measurements by the same operator	15 minutes
Secondary	Security and usability	collection of problems and incidents during clinical study	1 year
Secondary	Acceptability	satisfaction survey	1 year