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

Completed · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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

Key facts

Study ID

NCT06351761

Run by

Withings

People needed

373

Starts

2024-06-03

Expected to finish

2025-11-26

Last updated by the study team

2026-02-18

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• FWD Clinical Research — Boca Raton, Florida, United States
• Diverse Clinical Research — Miami, Florida, United States
• Henri Mondor University Hospital — Créteil, Val de Marne, France
• Centre Cardiopole Trubert — Paris, France

Full record on ClinicalTrials.gov

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