Clinical Validation of the Withings ECG Monitor for the Detection of Atrial Fibrillation

NCT ID: NCT05266235

Last Updated: 2023-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 274 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-14
• Study Completion Date: 2022-07-28

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Withings WBS08 and 12-lead reference ECG

The electrodes of the 12-lead ECG will be set up on the participants, before they step on withings WBS08 to have ECGs simultaneously recorded by the study device and the control device

Group Type: EXPERIMENTAL

Validation of the Withings bodyscan scale WBS08

Intervention Type: DEVICE

Participants will undergo simultaneous recordings of ECGs with the comparator and the study device

Interventions

Validation of the Withings bodyscan scale WBS08

Participants will undergo simultaneous recordings of ECGs with the comparator and the study device

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Withings

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas Lellouche, MD

Role: PRINCIPAL_INVESTIGATOR

Henri Mondor University Hospital

Locations

Cliniques Universitaires de Bruxelles - Hôpital Erasme

Brussels, , Belgium

Henri Mondor University Hospital

Créteil, Val De Marne, France

Poitiers University Hospital

Poitiers, Vienne, France

George Pompidou European Hospital

Paris, , France

Countries

Belgium; France

Other Identifiers

2021-A02730-41

Identifier Type: -

Identifier Source: org_study_id