Clinical Performance of Withings Move ECG Software for Atrial Fibrillation Detection

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

234 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-20

Study Completion Date

2020-10-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Withings Move ECG watch is designed to record ECG and detect automatically atrial fibrillation. The aim of this study is to validate the performance of Move ECG watch to detect atrial fibrillation compared to a reference 12-lead ECG.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Validation Study of a Watch for the Detection of Atrial Fibrillation

NCT04041466

Atrial Fibrillation Arrythmia, Cardiac

COMPLETED NA

Validation Study of the Watch HWA09 and Its Softwares ECG-SW1 and PPG-SW1 for the Detection of Atrial Fibrillation

NCT04351386

Atrial Fibrillation Arrythmia, Cardiac

COMPLETED

Withings ECG-app Study

NCT05316350

Atrial Fibrillation

COMPLETED NA

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

NCT05266235

Atrial Fibrillation

COMPLETED NA

Exploratory Study of Apple Watch Electrocardiographic Diagnostic Performance Enhanced by an Artificial Intelligence Algorithm

NCT04792905

Atrial Fibrillation

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients with atrial fibrillation are included in hospitals. On each patient, ECG with Move ECG and the reference 12-lead ECG are recorded simultaneously. Both records are then reviewed by independent cardiologists to assess

1. The presence or absence of atrial fibrillation
2. if waveforms of ECG recorded with Move ECG compared with the reference.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

atrial fibrillation (AF)

Patients diagnosed with AF during reference ECG

ECG measurement

Intervention Type DIAGNOSTIC_TEST

Simultaneous recording of a single-lead ECG signal with the Withings Move ECG and ECG signal for the reference 12-lead ECG

sinus rhythm (SR)

Patients diagnosed with SR during reference ECG

ECG measurement

Intervention Type DIAGNOSTIC_TEST

Simultaneous recording of a single-lead ECG signal with the Withings Move ECG and ECG signal for the reference 12-lead ECG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ECG measurement

Simultaneous recording of a single-lead ECG signal with the Withings Move ECG and ECG signal for the reference 12-lead ECG

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* male or female who are 18 years or older
* Subject who signed the written informed consent form

Exclusion Criteria

* Vulnerable subject with regard to regulations
* Pregnant, parturient or breastfeeding woman,
* Subject who is deprived of liberty by judicial, medical or administrative decision,
* Underage subject,
* Legally protected subject, or subject who is unable to sign the written informed consent form,
* Subject who is not beneficiary or not affiliated to a social security scheme,
* Subject within several of the above categories,
* Subject who refused to participate in the study,
* Subject in physical incapacity to wear a wrist-worn watch
* Subject with electrical stimulation by pacemaker

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No