Evaluation of Cardiags Trimod, a New Medical Device for Screening Cardiac Abnormalities
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- CARDIAGS
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Heart rhythm disorders
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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,
Outcomes
Primary Outcomes
Heart rhythm disorders
Time Frame: 15 minutes
Abnormal and irregular heart rhythm
Murmurs detection
Time Frame: 15 minutes
Evaluate the performance of Cardiags Trimod compared to a reference examination, echocardiography, for the detection of murmurs: Presence/Absence
Secondary Outcomes
- Reproductibilty of measurements(15 minutes)
- Security and usability(1 year)
- Acceptability(1 year)
- Accuracy of cardiac intervals measures(15 minutes)