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

RecruitingNAAges 18 Years - anyAllClinique Bizet
NCT07732283 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • standard 10-electrode ECG acquisition
  • 4-electrode DigitalCardio acquisition
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Where

2 sites
Benkessou
Paris, France
Bizet Clinic
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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