Health TrialsbyHealthPanel

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

Conditions4-electrode Tablet-based Electrocardiogram (ECG) SystemElectrical Activity of the HeartAtrial or Ventricular ArrhythmiasIntracardiac Conduction AbnormalitiesQT Interval ProlongationMyocardial IschemiaVentricular HypertrophyTandard 12-lead (10-electrode) ECG Device
Trial statusRecruiting
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

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • standard 10-electrode ECG acquisition

    Device

    Patient undergoes standard 10-electrode ECG acquisition. Then anonymized ECG traces is printed are submitted to independent evaluators. Evaluators independently assess trace quality based on standardized criteria, comparing automated measurements (frontal axis, median QRS duration, and QT interval) and counting any missing or erroneous leads. Followed immediately by 4-electrode DigitalCardio acquisition.

  • 4-electrode DigitalCardio acquisition

    Device

    Patient undergoes 4-electrode DigitalCardio acquisition acquisition. Then anonymized ECG traces is printed are submitted to independent evaluators. Evaluators independently assess trace quality based on standardized criteria, comparing automated measurements (frontal axis, median QRS duration, and QT interval) and counting any missing or erroneous leads. Followed immediately by standard 10-electrode ECG acquisition.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: standard 10-electrode ECGOther 2 interventions
Group B: 4-electrode DigitalCardioActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Comparison of Procedure Time Between 4-Electrode DigitalCardio® ECG and Standard 12-Lead ECG

Time elapsed from the initiation of electrode placement to the obtaining of a complete ECG trace for both the 4-electrode DigitalCardio® system and the standard 12-lead ECG device. Unit of Measure: Minutes

Time frame
1 day

Secondary outcomes

1

Comparative Quality Assessment of ECG Traces

Proportion of paired recordings in which an independent cardiologist prefers the 4-electrode DigitalCardio® trace compared to the standard 12-lead ECG trace, based on visual evaluation of signal clarity and the presence of artifacts/interference. Unit of Measure: Percentage of paired recordings

Time frame
1 day
2

Intraclass Correlation Coefficient (ICC) for Quantitative ECG Parameters

Degree of agreement for quantitative clinical parameters (e.g., QRS duration, QT interval, frontal axis measurements) automatically provided by both the 4-electrode DigitalCardio® system and the standard 12-lead ECG device. Unit of Measure: Intraclass Correlation Coefficient (ICC) (ranging from 0 to 1, where higher values indicate better agreement)

Time frame
1 day
3

Diagnostic Concordance for Cardiac Pathology

Agreement in detecting the presence or absence of cardiac pathology using the 4-electrode DigitalCardio® system compared to the standard 12-lead ECG (gold standard). Unit of Measure: Percentage of concordant diagnostic evaluations

Time frame
1 day
4

Healthcare Professional Satisfaction Score

Overall user satisfaction regarding the ease of use of the DigitalCardio® tablet device, evaluated by participating healthcare professionals using a structured Likert scale. The score ranges from 1 (strongly disagree / highly unsatisfied) to 5 (strongly agree / highly satisfied), where higher scores indicate a better outcome (higher satisfaction). Unit of Measure: Score on a scale

Time frame
1 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clinique Bizet

Lead sponsor

Source ClinicalTrials.gov
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