4-electrode ECG (DigitalCardio®) vs Standard 10-electrode ECG: Evaluating Ease of Use and Recording Quality

Summary

The goal of this clinical trial is to compare the time required to record a complete Electrocardiogram (ECG) trace using the DigitalCardio (CardioSecur®) tablet device versus a standard 12-lead ECG device in eligible patients. The main questions it aims to answer are: Is there a difference in diagnostic recording time (in minutes) between the DigitalCardio tablet and a standard ECG machine? How do the two devices compare in terms of trace quality (including QRS duration, QT interval, frontal axis measurements, and missing/erroneous leads)? How satisfied are healthcare professionals with the CardioSecur® device? Researchers will compare Group A (standard 10-electrode ECG followed by 4-electrode ECG) to Group B (4-electrode ECG followed by standard 10-electrode ECG) in a 1:1 randomized crossover design to evaluate recording efficiency and trace quality. Participants will: Complete an initial screening visit with the principal investigator to review eligibility criteria and sign the informed consent form. Be randomly assigned (1:1 ratio) to either Group A or Group B. Undergo both ECG recording methods sequentially (a standard 10-electrode ECG and a 4-electrode ECG using the DigitalCardio tablet), while researchers measure the total time elapsed from electrode placement to obtaining a complete trace.

Eligibility

Inclusion Criteria:

Hospitalized Cardiology Patients:

* Age minimum 18 years
* Hospitalized for an acute or chronic cardiac condition (e.g., heart failure, acute coronary syndrome, arrhythmia, valvular heart disease, etc.)
* Ability to give informed consent
* Hemodynamic stability permitting the performance of an ECG without clinical risk

Cardiology Outpatients:

* Age minimum of 18 years
* Follow-up for a known cardiac condition or suspected cardiovascular disease
* No contraindications to performing an ECG
* Informed consent obtained

Exclusion Criteria:

* Minor patient (\< 18 years of age)
* Adult subject under legal protection, under temporary guardianship, curatorship, or tutelage
* Patient refusing to participate in the study
* Presence of an implantable cardiac device (e.g., pacemaker, defibrillator) that may interfere with ECG measurements
* Severe skin condition preventing the placement of electrodes
* Physical or cognitive inability to follow the study protocol
* Current pregnancy

Conditions9

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