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

NCT06351761 | Completed FDA Device

• 1 other identifier: SCT02-ECG
• Study Type: interventional
• Target: 373
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Rhythm classification by ranges of heart rate

  10 months

• Quality of plots measured by the IMD - ECG Waveform Visibility

  10 months

• Quality of plots measured by the IMD - ECG Waveforms Polarity

  10 months

• Quality of plots measured by the IMD - ECG Waveforms Intervals

  10 months

• Quality of plots measured by the IMD - Heart Rate calculation

  10 months

Study Arms (3)

Normal Sinus Rhythm

EXPERIMENTAL

Simultaneous ECG recording of patient with Normal Sinus Rhythm with investigational and reference devices

Device: Investigational Device (Withings SCT02) 30 second Electrocardiogram recording; Device: Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recording

Atrial Fibrillation

EXPERIMENTAL

Simultaneous ECG recording of patient with Atrial Fibrillation with investigational and reference devices

Device: Investigational Device (Withings SCT02) 30 second Electrocardiogram recording; Device: Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recording

Arrhythmia other than Atrial Fibrillation

EXPERIMENTAL

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; Device: Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recording

Interventions

Investigational Device (Withings SCT02) 30 second Electrocardiogram recording DEVICE

30 second ECG recording with investigational device (Withings SCT02)

Arrhythmia other than Atrial Fibrillation; Atrial Fibrillation; Normal Sinus Rhythm

Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recording DEVICE

30 second ECG recording with reference device (Schiller Cardiovit FT-1)

Arrhythmia other than Atrial Fibrillation; Atrial Fibrillation; Normal Sinus Rhythm

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Withings: lead

Study Sites (4)

FWD Clinical Research

Boca Raton, Florida, 33486, United States

Location

Diverse Clinical Research

Miami, Florida, 33175, United States

Location

Henri Mondor University Hospital

Créteil, Val de Marne, 94000, France

Location

Centre Cardiopole Trubert

Paris, France

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: April 8, 2024
• Study Start: June 3, 2024
• Primary Completion: June 10, 2025
• Study Completion: November 26, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); FR (2)