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

NCT07732283 | Not Yet Recruiting

• 1 other identifier: 2026-A00856-45
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Electrical Activity of the Heart; Atrial or Ventricular Arrhythmias; Intracardiac Conduction Abnormalities; Myocardial Ischemia; Ventricular Hypertrophy; 4-electrode Tablet-based Electrocardiogram (ECG) System; QT Interval Prolongation; Tandard 12-lead (10-electrode) ECG Device

Keywords

4-electrode tablet-based Electrocardiogram (ECG) system; standard 12-lead (10-electrode) ECG device

Outcome Measures

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

  1 day

Secondary Outcomes (5)

• Comparative Quality Assessment of ECG Traces

  1 day

• Intraclass Correlation Coefficient (ICC) for Quantitative ECG Parameters

  1 day

• Diagnostic Concordance for Cardiac Pathology

  1 day

• Healthcare Professional Satisfaction Score

  1 days

• Incidence of Device-Related Technical Incidents for 4-electrode DigitalCardio® system

  1 day

Study Arms (2)

standard 10-electrode ECG

OTHER

Undergoes standard 10-electrode ECG acquisition first

Device: standard 10-electrode ECG acquisition; Device: 4-electrode DigitalCardio acquisition

4-electrode DigitalCardio

ACTIVE COMPARATOR

Undergoes 4-electrode DigitalCardio

Device: standard 10-electrode ECG acquisition; Device: 4-electrode DigitalCardio acquisition

Interventions

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; standard 10-electrode ECG

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.

4-electrode DigitalCardio; standard 10-electrode ECG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Clinique Bizet: lead

Study Sites (2)

Benkessou

Paris, 75016, France

Location

Bizet Clinic

Paris, 75016, France

Location

Related Publications (24)

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MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Bouchra BENKESSOU Chef de projet Recherche Clinique

CONTACT

+33 7 64 48 60 16; b.benkessou@hexagone-sante-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

FR (2)