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WIBOFA - Validation of SCT02 With ECG-App for Detection of AF

WIBOFA - Validation of SCT02 With ECG-App for Detection of AF

Recruiting
22 years and older
All
Phase N/A

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Overview

The aim of the study is to evaluate the performance of Withings SCT02 with embedded Withings ECG-app in the automatic detection of atrial fibrillation

Eligibility

Inclusion Criteria:

  • Male or female who are 22 years of age or older
  • Subject able to read, understand, and provide written informed consent
  • Subject willing and able to participate in the study procedures as described in the consent form
  • Subject able to communicate effectively with and willing to follow instructions from the study staff

Exclusion Criteria:

  • Subject with an implanted electrical device (i.e. pacemaker, ICD …), whether active or inactive
  • Pathologic disorders that may affect motricity resulting in significant hands tremor that prevents subject from being able to hold still (e.g. Parkinson disease)
  • Myocardial Infarction (MI) within 90 days prior to the enrollment
  • Pulmonary embolism or pulmonary infarction within 90 days prior to the enrollment
  • Stroke or Transient Ischemic Attack (TIA) within 90 days prior to the enrollment
  • Active or history of life-threatening rhythms as determined by investigators (e.g. ventricular tachycardia, ventricular fibrillation, 3rd degree heart block)
  • Any cardiovascular disease that investigators would consider as a risk to subject or renders data uninterpretable (e.g. recent or ongoing unstable angina, decompensated heart failure, active myocarditis or pericarditis)
  • Active or symptomatic skin disease on Schiller electrode attachment sites or fingertips which would be in contact with BeamO electrodes (e.g. eczema, rosacea, impetigo, dermatomyositis or allergic contact dermatitis)
  • Known sensitivity to medical adhesives, isopropyl alcohol,, electrocardiogram (ECG) electrodes, including known allergy or sensitivity to stainless steel (used in BeamO electrodes).

Study details
    Atrial Fibrillation

NCT06351761

Withings

21 October 2025

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