Validation Study of a Watch for the Detection of Atrial Fibrillation
MOVE-ECG
Validation of the Watch Withings HWA08 for the Detection of Atrial Fibrillation
1 other identifier
interventional
140
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable atrial-fibrillation
Started Jun 2019
Shorter than P25 for not_applicable atrial-fibrillation
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2019
CompletedFirst Submitted
Initial submission to the registry
July 31, 2019
CompletedFirst Posted
Study publicly available on registry
August 1, 2019
CompletedAugust 5, 2019
August 1, 2019
1 month
July 31, 2019
August 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
AF and SR classification accuracy
sensitivity and specificity of detection of AF and SR from 1-lead ECG against reference 12-lead ECG
1 visit (30 minutes)
Secondary Outcomes (2)
Quality of the 1-lead ECG strips
1 visit (30 minutes)
safety evaluation
1 visit (30 minutes)
Study Arms (3)
Atrial fibrillation (AF)
EXPERIMENTALPatients diagnosed with AF during reference ECG
Sinus Rhythm (SR)
EXPERIMENTALPatients diagnosed with SR during reference ECG
Other Arrythmia
EXPERIMENTALPatients diagnosed with an arrhythmia other than AF during the reference ECG
Interventions
Single-lead ECG with Withings watch HWA08 and reference 12-lead ECG
Eligibility Criteria
You may qualify if:
- adults, men or women, at least 18 years old
- person having signed the informed consent form
- person affiliated to a social security system
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Clinique AXIUM Centre de cardiologie
Aix-en-Provence, 13090, France
Centre Cardiologique du Nord
Saint-Denis, 93200, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2019
First Posted
August 1, 2019
Study Start
June 7, 2019
Primary Completion
July 12, 2019
Study Completion
July 12, 2019
Last Updated
August 5, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share