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Clinical Trials/NCT04041466
NCT04041466
Completed
Not Applicable

Validation of the Watch Withings HWA08 for the Detection of Atrial Fibrillation

Withings2 sites in 1 country140 target enrollmentJune 7, 2019
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ConditionsAtrial FibrillationArrythmia, Cardiac

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
Withings
Enrollment
140
Locations
2
Primary Endpoint
AF and SR classification accuracy
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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).

Registry
clinicaltrials.gov
Start Date
June 7, 2019
End Date
July 12, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Withings
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

AF and SR classification accuracy

Time Frame: 1 visit (30 minutes)

sensitivity and specificity of detection of AF and SR from 1-lead ECG against reference 12-lead ECG

Secondary Outcomes

  • Quality of the 1-lead ECG strips(1 visit (30 minutes))
  • safety evaluation(1 visit (30 minutes))

Study Sites (2)

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