Validation Study of WITHINGS BPM Core for the Detection of Atrial Fibrillation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Withings
- Enrollment
- 160
- Locations
- 2
- Primary Endpoint
- Sensitivity of the automatic classification in AF by BPM Core single-lead ECG against reference 12-lead ECG
Study Overview
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).
Detailed Description
BPM Core is a blood-pressure monitor with an build-in single-channel electrocardiogram similar to a lead I.
Primary objective:
The primary objective is to demonstrate that Withings BPM Core has acceptable sensitivity and specificity in the automatic identification of AF and SR in comparison with a gold-standard diagnosis from a 12-lead ECG by board certified cardiologists.
The algorithm classifies the device signals into four categories: normal sinus rhythm (RSN), AF, arrhythmia other than AF, or non-interpretable. The latter category includes signals of insufficient quality to be interpreted with confidence.
This classification will be compared to the diagnosis made by three independent, blinded cardiologists based on a 12-lead ECG. The final diagnosis retained will be decided by majority with adjudication by a consensus of 3 to 6 cardiologists. The sensitivity and specificity of the device will then be estimated.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
atrial fibrillation (AF)
Patients diagnosed with AF during reference ECG
Intervention: ECG measurement (Diagnostic Test)
sinus rhythm (SR)
Patients diagnosed with SR during reference ECG
Intervention: ECG measurement (Diagnostic Test)
Outcomes
Primary Outcomes
Sensitivity of the automatic classification in AF by BPM Core single-lead ECG against reference 12-lead ECG
Time Frame: 1 year
sensitivity from the 2x2 confusion matrix AF vs 'non-AF'
Secondary Outcomes
- Sensitivity of the cardiologists' classification in SR from the BPM Core ECG(1 year)
- Accuracy of the positivity of P-waves of single-lead ECG from BPM Core(1 year)
- Sensitivity of the cardiologists' classification in AF from the BPM Core ECG(1 year)
- Accuracy of the visibility of QRS-complexes of single-lead ECG from BPM Core(1 year)
- Accuracy of the positivity of QRS-complexes of single-lead ECG from BPM Core(1 year)
- Accuracy of the visibility of T-waves of single-lead ECG from BPM Core(1 year)
- Accuracy of the visibility of P-waves of single-lead ECG from BPM Core(1 year)
- Accuracy of the positivity of T-waves of single-lead ECG from BPM Core(1 year)