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

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

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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Investigational Device (Withings SCT02) 30 second Electrocardiogram recording; Device: Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recording

• Study Type: Interventional
• Enrollment (Actual): 373
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Centre Cardiopole Trubert
  • Val de Marne
    • Créteil, Val de Marne, France, 94000
      • Henri Mondor University Hospital
• United States
  • Florida
    • Boca Raton, Florida, United States, 33486
      • FWD Clinical Research
    • Miami, Florida, United States, 33175
      • Diverse Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal Sinus Rhythm; Simultaneous ECG recording of patient with Normal Sinus Rhythm with investigational and reference devices	Device: Investigational Device (Withings SCT02) 30 second Electrocardiogram recording; 30 second ECG recording with investigational device (Withings SCT02); Device: Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recording; 30 second ECG recording with reference device (Schiller Cardiovit FT-1)
Experimental: Atrial Fibrillation; Simultaneous ECG recording of patient with Atrial Fibrillation with investigational and reference devices	Device: Investigational Device (Withings SCT02) 30 second Electrocardiogram recording; 30 second ECG recording with investigational device (Withings SCT02); Device: Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recording; 30 second ECG recording with reference device (Schiller Cardiovit FT-1)
Experimental: Arrhythmia other than Atrial Fibrillation; Simultaneous ECG recording of patient with Arrhythmia other than Atrial Fibrillation with investigational and reference devices	Device: Investigational Device (Withings SCT02) 30 second Electrocardiogram recording; 30 second ECG recording with investigational device (Withings SCT02); Device: Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recording; 30 second ECG recording with reference device (Schiller Cardiovit FT-1)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Co-primary outcome 1 - Sensitivity of Investigational Device	Sensitivity (percentage of true positives) in detecting AF from conclusive recordings generated by the software under test, that is recordings resulting in a classification of AF or SR by the IMD, compared to the reference 12-lead ECG.	10 months
Co-primary outcome 2 - Specificity of Investigational Device	Specificity (percentage of true negatives) in detecting AF from conclusive recordings generated by the software under test, that is recordings resulting in a classification of AF or SR by the IMD, compared to the reference 12-lead ECG.	10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rhythm classification by ranges of heart rate	On pairs of strips such that the rhythm classification of the 12-lead ECG is either SR or AF and such that the strip generated by the IMD is classified as either SR or AF, the classification into four heart rate subgroups will be evaluated.; Sinus Rhythm, (50-99 bpm); High Heart Rate (No signs of AFib) (100-150 bpm); Atrial Fibrillation (50-99 bpm),; Atrial Fibrillation (100-150 bpm)	10 months
Quality of plots measured by the IMD - ECG Waveform Visibility	Clinical Equivalence of ECG waveforms will be qualitatively and quantitatively assessed between the 1-lead generated by the IMD and the lead I of the 12-lead reference ECG determined by certified cardiologists. Equivalence will be evaluated by FV : Fraction of concordant assessments of visibility between the IMD and the reference	10 months
Quality of plots measured by the IMD - ECG Waveforms Polarity	On waveforms with waves that are Visible, Clinical Equivalence of ECG waveforms will be qualitatively and quantitatively assessed between the 1-lead generated by the IMD and the lead I of the 12-lead reference ECG determined by certified cardiologists. Equivalence will be evaluated by FP : Fraction of concordant assessment of polarity between IMD and reference	10 months
Quality of plots measured by the IMD - ECG Waveforms Intervals	Determine the equivalence of PR, QRS and QT intervals durations between the lead I of the IMD and the lead I of the reference ECG determined by an independent board of certified cardiologists. Duration error will be calculated.	10 months
Quality of plots measured by the IMD - Heart Rate calculation	Determine the equivalence of the heart rate (HR) calculated by the IMD and the HR measured by an independent board of certified cardiologists or cardiology technicians on the ECG of the reference.	10 months

Collaborators and Investigators

• Sponsor: Withings

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2024
• Primary Completion (Actual): June 10, 2025
• Study Completion (Actual): November 26, 2025

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: SCT02-ECG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No