NCT07732283Recruiting
4-electrode ECG (DigitalCardio®) vs Standard 10-electrode ECG: Evaluating Ease of Use and Recording Quality
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 23 Jul 2026
- Start date
- 4 Sept 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Clinique Bizet
- NCT number
- NCT07732283
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 4 Sept 2026 to the primary completion date, 31 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Presence of an implantable cardiac device (e.g., pacemaker, defibrillator) that may interfere with ECG measurements
- Severe skin condition preventing the placement of electrodes
Age
- Minor patient (\< 18 years of age)
Other
- Adult subject under legal protection, under temporary guardianship, curatorship, or tutelage
- Patient refusing to participate in the study
- Physical or cognitive inability to follow the study protocol
- Current pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bizet Clinic Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Benkessou Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.