Validation Study of a Watch for the Detection of Atrial Fibrillation

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Arrythmia, Cardiac

• 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

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