4-electrode ECG (DigitalCardio®) vs Standard 10-electrode ECG: Evaluating Ease of Use and Recording Quality
Starting soon · Not applicable
Conditions studied: 4-electrode Tablet-based Electrocardiogram (ECG) System, Electrical Activity of the Heart, Atrial or Ventricular Arrhythmias, Intracardiac Conduction Abnormalities, QT Interval Prolongation, Myocardial Ischemia, Ventricular Hypertrophy, Tandard 12-lead (10-electrode) ECG Device
In brief
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.
Key facts
- Study ID
- NCT07732283
- Run by
- Clinique Bizet
- People needed
- 50
- Starts
- 2026-06-01
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-07-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Benkessou — Paris, France
- Bizet Clinic — Paris, France
Full record on ClinicalTrials.gov
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