Validation Study of a Watch for the Detection of Atrial Fibrillation

NCT ID: NCT04041466

Last Updated: 2019-08-05

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

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-07

Study Completion Date

2019-07-12

Brief Summary

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The proposed clinical study aims at validating the diagnostic performance, in comparison with a reference ECG, of Withings HWA08 watch for the automatic identification of atrial fibrillation (AF).

Detailed Description

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Conditions

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Atrial Fibrillation Arrythmia, Cardiac

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Atrial fibrillation (AF)

Patients diagnosed with AF during reference ECG

Group Type EXPERIMENTAL

AF detection by ECG

Intervention Type DIAGNOSTIC_TEST

Single-lead ECG with Withings watch HWA08 and reference 12-lead ECG

Sinus Rhythm (SR)

Patients diagnosed with SR during reference ECG

Group Type EXPERIMENTAL

AF detection by ECG

Intervention Type DIAGNOSTIC_TEST

Single-lead ECG with Withings watch HWA08 and reference 12-lead ECG

Other Arrythmia

Patients diagnosed with an arrhythmia other than AF during the reference ECG

Group Type EXPERIMENTAL

AF detection by ECG

Intervention Type DIAGNOSTIC_TEST

Single-lead ECG with Withings watch HWA08 and reference 12-lead ECG

Interventions

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AF detection by ECG

Single-lead ECG with Withings watch HWA08 and reference 12-lead ECG

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* adults, men or women, at least 18 years old
* person having signed the informed consent form
* person affiliated to a social security system

Exclusion Criteria

* vulnerable subject according to current regulation:

* pregnant woman, parturient or breastfeeding
* subject deprived of freedom by judicial, medical or administrative decision
* subject legally protected or unable to express his consent
* subject non-beneficiary of healthcare
* subject falling into more than one of the above categories
* subject who refused to participate in the study
* subject in linguistic or psychic incapacity to sign a written informed consent form
* subject in physical incapacity to wear a watch on their wrist
* subject with electrical stimulation by pacemaker
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinact

OTHER

Sponsor Role collaborator

Withings

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique AXIUM Centre de cardiologie

Aix-en-Provence, , France

Site Status

Centre Cardiologique du Nord

Saint-Denis, , France

Site Status

Countries

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France

Other Identifiers

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2019-A00721-56

Identifier Type: -

Identifier Source: org_study_id

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