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

September 9, 2026 updated by: Clinique Bizet

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized, crossover clinical trial designed to compare the efficiency, trace quality, and user satisfaction of a novel 4-electrode tablet-based Electrocardiogram (ECG) system (DigitalCardio / CardioSecur®) against a standard 12-lead (10-electrode) ECG device.

Background and Rationale

An electrocardiogram (ECG) is a fundamental diagnostic tool used to record the electrical activity of the heart. Conventional 12-lead ECGs require placing 10 individual electrodes on a patient's limbs and chest while the patient is lying down. While highly detailed, electrode placement and device setup can be time-consuming in clinical workflows. The DigitalCardio tablet system utilizes a simplified 4-electrode setup designed to streamline data acquisition without compromising diagnostic accuracy.

Study Design and Procedures

After an initial screening process led by the principal investigator, eligible participants receive detailed study information and provide written informed consent. Enrolled participants are then randomly assigned in a 1:1 ratio to one of two sequence groups to control for order effects:

*Group A:Undergoes standard 10-electrode ECG acquisition first, followed immediately by 4-electrode DigitalCardio acquisition.

Group B: Undergoes 4-electrode DigitalCardio acquisition first, followed immediately by standard 10-electrode ECG acquisition.

To maintain consistency, both ECG recordings for a given participant are performed by the same healthcare operator within a minimal time interval.

Key Measurements

  1. Diagnostic Time:Research staff record the exact time elapsed (in minutes) from the initiation of electrode placement to the successful capture of a complete ECG trace for both devices.
  2. Trace Quality and Concordance:Printed and anonymized ECG traces 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.
  3. Healthcare Professional Satisfaction:Participating healthcare professionals complete a structured questionnaire evaluating user satisfaction and usability of the CardioSecur® device in routine practice.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: standard 10-electrode ECG
Undergoes standard 10-electrode ECG acquisition first
Device: standard 10-electrode ECG acquisition
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.
Device: 4-electrode DigitalCardio acquisition
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.
Active Comparator: 4-electrode DigitalCardio
Undergoes 4-electrode DigitalCardio
Device: standard 10-electrode ECG acquisition
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.
Device: 4-electrode DigitalCardio acquisition
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Procedure Time Between 4-Electrode DigitalCardio® ECG and Standard 12-Lead ECG
Time Frame: 1 day

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparative Quality Assessment of ECG Traces
Time Frame: 1 day

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
1 day
Intraclass Correlation Coefficient (ICC) for Quantitative ECG Parameters
Time Frame: 1 day

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)
1 day
Diagnostic Concordance for Cardiac Pathology
Time Frame: 1 day

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
1 day
Healthcare Professional Satisfaction Score
Time Frame: 1 days

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
1 days
Incidence of Device-Related Technical Incidents for 4-electrode DigitalCardio® system
Time Frame: 1 day

Total number of technical malfunctions, failures, or operational incidents reported for 4-electrode DigitalCardio® system devices during procedures. And how the issu is been managed.

Unit of Measure: Number of technical incidents
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique Bizet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

July 23, 2026

First Submitted That Met QC Criteria

July 23, 2026

First Posted (Actual)

July 28, 2026

Study Record Updates

Last Update Posted (Actual)

September 11, 2026

Last Update Submitted That Met QC Criteria

September 9, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-A00856-45

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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