Validation Study of a Watch for the Detection of Atrial Fibrillation

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Arrythmia, Cardiac
• Interventions: Diagnostic Test: AF detection by ECG

• Registration Number: NCT04041466
• Lead Sponsor: Withings

Brief Summary

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

Not available

Study Timeline

• Study Start: 2019-06-07
• Primary Completion: 2019-07-12
• Study Completion: 2019-07-12
• Study First Submitted: 2019-07-31
• Study First Submitted QC: 2019-07-31
• Status Verified: 2019-08
• Study First Posted: 2019-08-01
• Last Update Submitted: 2019-08-02
• Last Update Posted: 2019-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Other Arrythmia	AF detection by ECG	Patients diagnosed with an arrhythmia other than AF during the reference ECG
Atrial fibrillation (AF)	AF detection by ECG	Patients diagnosed with AF during reference ECG
Sinus Rhythm (SR)	AF detection by ECG	Patients diagnosed with SR during reference ECG

Primary Outcome Measures

Name	Time	Method
AF and SR classification accuracy	1 visit (30 minutes)	sensitivity and specificity of detection of AF and SR from 1-lead ECG against reference 12-lead ECG

Secondary Outcome Measures

Name	Time	Method
Quality of the 1-lead ECG strips	1 visit (30 minutes)	sensitivity and specificity of detection of AF and SR from 1-lead ECG strips reviewed by a blind, trained cardiologist against reference 12-lead ECG
safety evaluation	1 visit (30 minutes)	frequency of adverse events

Trial Locations

Locations (2)

Clinique AXIUM Centre de cardiologie; 🇫🇷 Aix-en-Provence, France

Centre Cardiologique du Nord; 🇫🇷 Saint-Denis, France