Murmur, Heart, Rhythm; Abnormal
Conditions
Keywords
Medical examination device, Connected cardiac auscultation, Sensors, Heartbeat, Heart sounds, Pulse wave, Electrocardiogram, Pathological heart sounds
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.
Interventions
DEVICEDiagnostic 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
Sponsors
CARDIAGS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
This is a cross-sectional diagnostic study with collection of information from the gold standard (or reference tests) and the new device
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Murmurs detection | 15 minutes | Evaluate the performance of Cardiags Trimod compared to a reference examination, echocardiography, for the detection of murmurs: Presence/Absence |
| Heart rhythm disorders | 15 minutes | Abnormal and irregular heart rhythm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of cardiac intervals measures | 15 minutes | Measures accuracy |
| Reproductibilty of measurements | 15 minutes | Repetition of three measurements by the same operator |
| Security and usability | 1 year | collection of problems and incidents during clinical study |
| Acceptability | 1 year | satisfaction survey |
Countries
France
Outcome results
None listed