Withings ECG-app Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

685 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-15

Study Completion Date

2023-08-15

Brief Summary

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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

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Atrial Fibrillation

Group Type EXPERIMENTAL

Electrocardiogram recording

Intervention Type DEVICE

ECG recording with investigational device

Electrocardiogram recording

Intervention Type DEVICE

ECG recording with reference device

Normal Sinus Rhythm

Group Type EXPERIMENTAL

Electrocardiogram recording

Intervention Type DEVICE

ECG recording with investigational device

Electrocardiogram recording

Intervention Type DEVICE

ECG recording with reference device

Interventions

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Electrocardiogram recording

ECG recording with investigational device

Intervention Type DEVICE

Electrocardiogram recording

ECG recording with reference device

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No