Withings ECG-app Study

Withings

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Device: Electrocardiogram recording

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT05316350

HWA10-ECG

Details and patient eligibility

About

The aim of the study is to evaluate the performance of Withings HWA10 with embedded Withings ECG-app in the automatic detection of atrial fibrillation

Enrollment

685 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
Have a wrist circumference between 140 mm and 210 mm (measured at "band center" on the preferred wrist, 1cm from the bone. This location is determined by asking the volunteer to put on a normal wrist-watch and marking the skin with a pen/marker to outline the edges of the band.)

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 in physical incapacity to wear a watch on one wrist and place the other hand on top of the watch
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)
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 abnormal life-threatening rhythms (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 on both wrists or over electrode attachment sites
Known sensitivity to medical adhesives, isopropyl alcohol, watch bands, or electrocardiogram (ECG) electrodes including known allergy or sensitivity to fluoroelastomer bands primarily used in wrist worn fitness devices