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

Atrial Fibrillation Clinical Trial

— WIBOFA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06351761
• Other study ID #: SCT02-ECG
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: March 2025

Study information

• Verified date: May 2024
• Source: Withings
• Contact: David Campo
• Phone: +33 1.41.46.04.60
• Email: clinical-trials[@]withings.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 270
• Est. completion date: March 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Investigational Device (Withings SCT02) 30 second Electrocardiogram recording
30 second ECG recording with investigational device (Withings SCT02)
• Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recording
30 second ECG recording with reference device (Schiller Cardiovit FT-1)

Locations

Country	Name	City	State
France	Henri Mondor University Hospital	Créteil	Val De Marne
United States	FWD Clinical Research	Boca Raton	Florida
United States	Diverse Clinical Research	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Withings

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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