Validation Study of WITHINGS BPM Core for the Detection of Atrial Fibrillation

NCT04464499 | Active Not Recruiting

• 1 other identifier: 2019-A03346-51
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 2

Brief Summary

The proposed clinical study aims to validate the diagnostic performance, compared to a reference ECG, of the electrocardiographic function of the BPM Core developed by Withings for the automatic identification of atrial fibrillation (AF).

Conditions

Atrial Fibrillation; Cardiovascular Diseases; Arrhythmias, Cardiac

Keywords

atrial fibrillation; arrhythmia, cardiac; cardiovascular disease; heart disease; wearable electronic device; ECG; blood pressure monitor; electrocardiography

Outcome Measures

Primary Outcomes (2)

• Sensitivity of the automatic classification in AF by BPM Core single-lead ECG against reference 12-lead ECG

  sensitivity from the 2x2 confusion matrix AF vs 'non-AF'

  1 year

• Sensitivity of the automatic classification in AF by BPM Core single-lead ECG against reference 12-lead ECG

  sensitivity from the 2x2 confusion matrix NSR vs 'non-NSR'

  1 year

Secondary Outcomes (8)

• Sensitivity of the cardiologists' classification in AF from the BPM Core ECG

  1 year

• Sensitivity of the cardiologists' classification in SR from the BPM Core ECG

  1 year

• Accuracy of the visibility of P-waves of single-lead ECG from BPM Core

  1 year

• Accuracy of the positivity of P-waves of single-lead ECG from BPM Core

  1 year

• Accuracy of the visibility of QRS-complexes of single-lead ECG from BPM Core

  1 year

Study Arms (2)

atrial fibrillation (AF)

Patients diagnosed with AF during reference ECG

Diagnostic Test: ECG measurement

sinus rhythm (SR)

Patients diagnosed with SR during reference ECG

Diagnostic Test: ECG measurement

Interventions

ECG measurement DIAGNOSTIC_TEST

Simultaneous recording of a single-lead ECG signal with the Withings BPM Core and ECG signal for the reference 12-lead ECG

atrial fibrillation (AF); sinus rhythm (SR)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

in and out patients from cardiology services

You may qualify if:

• male or female who are 18 years or older
• Subject who signed the written informed consent form,
• Able to communicate effectively with and follow instructions from the study staff
• Person with an arm circumference between 22 and 42 cm

You may not qualify if:

• Vulnerable subject with regard to regulations
• Pregnant, parturient or breastfeeding woman,
• Subject who is deprived of liberty by judicial, medical or administrative decision,
• Underage subject,
• Legally protected subject, or subject who is unable to sign the written informed consent form,
• Subject who is not beneficiary or not affiliated to a social security scheme,
• Subject within several of the above categories,
• Subject who refused to participate in the study,
• Subject in linguistic or psychic incapacity to sign a written informed consent form,
• Subject in physical incapacity to wear a blood pressure monitor
• Subject with electrical stimulation by pacemaker
• Significant tremor that prevents subject from being able to hold still
• Known sensitivity to medical adhesives, isopropyl alcohol, or ECG electrodes

Sponsors & Collaborators

• Withings: lead

Study Sites (2)

ICPC Floréale

Bagnolet, 93170, France

Location

ICPC Turin

Paris, 75004, France

Location

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac; Cardiovascular Diseases; Heart Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Campo, PhD

  Withings

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 9, 2020
• Study Start: July 6, 2020
• Primary Completion: March 15, 2021
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)