Evaluating a device for detecting atrial fibrillation using an ECG app

Validation of Withings BeamO With Withings ECG-App for the Detection of Atrial Fibrillation

This study is testing a new device with an ECG app to see if it can accurately detect atrial fibrillation in adults.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 371 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Withings (Industry-sponsored)
• Locations: 4 sites (Boca Raton, Florida and 3 other locations)
• Trial ID: NCT06351761 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness of the Withings SCT02 device, which includes an ECG app, in automatically detecting atrial fibrillation (AF). Participants will undergo a 30-second electrocardiogram recording using the investigational device and a reference device for comparison. The study will include adults aged 22 and older who can provide informed consent and follow study procedures. Exclusion criteria include individuals with certain heart conditions or implanted electrical devices.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 22 and older who are able to provide informed consent and follow study instructions.

Not a fit: Patients with implanted electrical devices or recent serious cardiovascular events may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved methods for the early detection of atrial fibrillation, potentially reducing the risk of stroke and other complications.

How similar studies have performed: Other studies have shown promise in using mobile ECG devices for detecting atrial fibrillation, suggesting this approach may be effective.

Eligibility criteria

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).

Where this trial is running

Boca Raton, Florida and 3 other locations

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

Study contacts

• Study coordinator: Aline Criton

Conditions Atrial Fibrillation