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

Withings

Status: Enrolling

Conditions: Atrial Fibrillation

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06351761

SCT02-ECG

Details and patient eligibility

About

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

Enrollment: 371 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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371 participants in 3 patient groups

Normal Sinus Rhythm

Experimental group

Description:

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

Treatment:

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

Device: Investigational Device (Withings SCT02) 30 second Electrocardiogram recording

Atrial Fibrillation

Experimental group

Description:

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

Treatment:

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

Device: Investigational Device (Withings SCT02) 30 second Electrocardiogram recording

Arrhythmia other than Atrial Fibrillation

Experimental group

Description:

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

Treatment:

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

Device: Investigational Device (Withings SCT02) 30 second Electrocardiogram recording