4-electrode ECG (DigitalCardio®) vs Standard 10-electrode ECG: Evaluating Ease of Use and Recordi… (NCT07732283) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
4-electrode ECG (DigitalCardio®) vs Standard 10-electrode ECG: Evaluating Ease of Use and Recording Quality
France50 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of Procedure Time Between 4-Electrode DigitalCardio® ECG and Standard 12-Lead ECG
Timeframe: 1 day
Trial details
NCT IDNCT07732283
SponsorClinique Bizet
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2026-12
Contact for this trial
Bouchra BENKESSOU Chef de projet Recherche Clinique