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Validation Study of a Watch for the Detection of Atrial Fibrillation (MOVE-ECG)

Primary Purpose

Atrial Fibrillation, Arrythmia, Cardiac

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
AF detection by ECG
Sponsored by
Withings
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Arrhythmias, Cardiac, Cardiovascular diseases, Heart diseases, Wearable Electronic Devices, Electrocardiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinique AXIUM Centre de cardiologie
  • Centre Cardiologique du Nord

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Atrial fibrillation (AF)

Sinus Rhythm (SR)

Other Arrythmia

Arm Description

Patients diagnosed with AF during reference ECG

Patients diagnosed with SR during reference ECG

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of the 1-lead ECG strips
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
frequency of adverse events

Full Information

First Posted
July 31, 2019
Last Updated
August 2, 2019
Sponsor
Withings
Collaborators
Clinact
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1. Study Identification

Unique Protocol Identification Number
NCT04041466
Brief Title
Validation Study of a Watch for the Detection of Atrial Fibrillation
Acronym
MOVE-ECG
Official Title
Validation of the Watch Withings HWA08 for the Detection of Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 7, 2019 (Actual)
Primary Completion Date
July 12, 2019 (Actual)
Study Completion Date
July 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Withings
Collaborators
Clinact

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Arrythmia, Cardiac
Keywords
Atrial Fibrillation, Arrhythmias, Cardiac, Cardiovascular diseases, Heart diseases, Wearable Electronic Devices, Electrocardiography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atrial fibrillation (AF)
Arm Type
Experimental
Arm Description
Patients diagnosed with AF during reference ECG
Arm Title
Sinus Rhythm (SR)
Arm Type
Experimental
Arm Description
Patients diagnosed with SR during reference ECG
Arm Title
Other Arrythmia
Arm Type
Experimental
Arm Description
Patients diagnosed with an arrhythmia other than AF during the reference ECG
Intervention Type
Diagnostic Test
Intervention Name(s)
AF detection by ECG
Intervention Description
Single-lead ECG with Withings watch HWA08 and reference 12-lead ECG
Primary Outcome Measure Information:
Title
AF and SR classification accuracy
Description
sensitivity and specificity of detection of AF and SR from 1-lead ECG against reference 12-lead ECG
Time Frame
1 visit (30 minutes)
Secondary Outcome Measure Information:
Title
Quality of the 1-lead ECG strips
Description
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
Time Frame
1 visit (30 minutes)
Title
safety evaluation
Description
frequency of adverse events
Time Frame
1 visit (30 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Clinique AXIUM Centre de cardiologie
City
Aix-en-Provence
ZIP/Postal Code
13090
Country
France
Facility Name
Centre Cardiologique du Nord
City
Saint-Denis
ZIP/Postal Code
93200
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Validation Study of a Watch for the Detection of Atrial Fibrillation

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