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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinique Bizet

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • standard 10-electrode ECG acquisition
  • 4-electrode DigitalCardio acquisition

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators