Withings ECG-Monitor Study

Withings

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Device: Electrocardiogram recording

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT05316337

WBS08-ECG

Details and patient eligibility

About

The aim of the study is to evaluate the performance of Withings WBS08 with embedded Withings ECG Monitor in the automatic detection of atrial fibrillation

Enrollment

650 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

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

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 electrical stimulation by pacemaker
Patient with pathologic disorder that may affect motricity resulting in significant tremor that prevents subject from being able 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, 3 rd -degree heart block).
History of life-threatening rhythms as determined by the investigator (ventricular tachycardia, ventricular fibrillation, 3 rd -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