NCT05162599

Evaluation of Cardiags Trimod for Analysis of Cardiac Activity

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: CARDIAGS · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Murmur, Heart
• Rhythm; Abnormal

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-06-08
• Primary completion: 2023-06-08
• Completion: 2023-06-08
• First posted: 2021-12-17
• Last updated: 2024-01-25

Locations

1 site across 1 country: France