Clinical trial NCT05266235: Clinical Validation of the Withings ECG Monitor for the Detection of Atrial Fibrillation
Official title: Clinical Validation of the Withings ECG Monitor for the Detection of Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Withings
Sponsor class: INDUSTRY
First posted: 2022-03-04
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to demonstrate the performance of Withings WBS08 in the automatic identification of atrial fibrillation and sinus rhythm.

Detailed description: Patients included will be those presenting for consultation in the various participating clinical services. For each patient, an ECG will be recorded with the WBS08 and with the reference device Cardiovit FT1, at rest and after an exercise session.

Eligibility criteria: Inclusion Criteria:

* Male or female who are 18 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
* Subject affiliated to a social security system

For subjects enrolled into the AF population, subjects must have a known diagnosis of AF and be in AF at the time of screening. Subjects may have any type of AF including paroxysmal, persistent, and permanent AF.

Exclusion Criteria:

* Vulnerable subject with regard to regulations in force :
* Subject who is deprived of liberty by judicial, medical or administrative decision,
* Underage subject,
* Legally protected subject, or subject who is unable, linguistic or psychic incapacity, to sign the written informed consent form
* Subject within several of the above categories
* Subject who refused to participate in the study
* Subject mentally impaired resulting in limited ability to cooperate
* Subject with a pacemaker, ICD (Implantable cardioverter defibrillator) or other implanted electronic stimulator
* Patient with pathologic disorder that may affect motricity resulting in significant tremor that prevents subject from being ablle to hold still (e.g Parkinson disease)
* Patient unable to stay in an upright position for the duration of study measures
* Acute myocardial infarction (MI) within 90 days of screening or other cardiovascular disease that, in the opinion of the investigator, may increase the risk to the subject or renders data uninterpretable (e.g. recent or ongoing unstable angina, decompensated heart failure, active myocarditis or pericarditis)
* Acute pulmonary embolism or pulmonary infarction, within 90 days of screening
* Stroke or transient ischemic attack within 90 days of screening
* Active life-threatening rhythms as determined by the investigator (ventricular tachycardia, ventricular fibrillation, 3rd degree heart block).
* History of abnormal life-threatening rhythms as determined by the investigator (e.g., ventricular tachycardia, ventricular fibrillation, 3rd degree heart block)
* Symptomatic (or active) allergic skin reactions such as eczema, rosacea, impetigo, dermatomyositis or allergic contact dermatitis over electrode attachment sites
* Known sensitivity to medical adhesives, isopropyl alcohol, or electrocardiogram (ECG) electrodes including known allergy or sensitivity to fluoroelastomer bands
* Weight more than 180 kg

Primary outcomes:
measure: Performance in the identification of atrial fibrillation and sinus rhythm
timeFrame: 10 months
Secondary outcomes:
measure: Evaluation of the classification into heart rate subgroups
timeFrame: 10 months
measure: Assessment of the clinical equivalence of ECG waveforms
timeFrame: 10 months
measure: Assessment of the clinical equivalence of ECG waveforms
timeFrame: 10 months
measure: Determination of the heart rate
timeFrame: 10 months
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Cliniques Universitaires de Bruxelles - Hôpital Erasme
city: Créteil
country: France
facility: Henri Mondor University Hospital
state: Val De Marne
city: Poitiers
country: France
facility: Poitiers University Hospital
state: Vienne
city: Paris
country: France
facility: George Pompidou European Hospital
Study officials:
affiliation: Henri Mondor University Hospital
name: Nicolas Lellouche, MD
role: PRINCIPAL_INVESTIGATOR
References: