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Validation Study of the Watch HWA09 and Its Softwares ECG-SW1 and PPG-SW1 for the Detection of Atrial Fibrillation (WEFA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04351386
Recruitment Status : Recruiting
First Posted : April 17, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Withings

Brief Summary:
The proposed clinical study aims to validate the diagnostic performance, compared to a reference ECG, of the ECG-SW1 software and the PPG-SW1 software integrated into the HWA09 watch developed by Withings for the automatic identification of atrial fibrillation (AF).

Condition or disease Intervention/treatment
Atrial Fibrillation Arrythmia, Cardiac Device: AF Detection

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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation Study of the Watch HWA09 and Its Softwares ECG-SW1 and PPG-SW1 for the Detection of Atrial Fibrillation
Actual Study Start Date : December 20, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Atrial Fibrillation (AF)
Patients diagnosed with AF during reference ECG
Device: AF Detection
Recording PPG and single-lead ECG signals with the Withings HWA09 and ECG signal for the reference 12-lead ECG

Normal Sinus Rhythm (NSR)
Patients with NSR during reference ECG
Device: AF Detection
Recording PPG and single-lead ECG signals with the Withings HWA09 and ECG signal for the reference 12-lead ECG

Other Arrythmia
Patients diagnosed with an arrhythmia other than AF during the reference ECG
Device: AF Detection
Recording PPG and single-lead ECG signals with the Withings HWA09 and ECG signal for the reference 12-lead ECG




Primary Outcome Measures :
  1. Sensitivity of the automatic classification in AF by ECG-SW1 of HWA09 single-lead ECG against reference 12-lead ECG [ Time Frame: 1 year ]
    sensitivity from the 2x2 confusion matrix AF vs 'non-AF'

  2. Sensitivity of the automatic classification in NSR by ECG-SW1 of HWA09 single-lead ECG against reference 12-lead ECG [ Time Frame: 1 year ]
    sensitivity from the 2x2 confusion matrix NSR vs 'non-NSR'


Secondary Outcome Measures :
  1. Sensitivity of the automatic classification in AF by PPG-SW1 of the HWA09 PPG against reference 12-lead ECG [ Time Frame: 1 year ]
    sensitivity from the 2x2 confusion matrix AF vs 'non-AF'

  2. Sensitivity of the automatic classification in NSR by PPG-SW1 of the HWA09 PPG against reference 12-lead ECG [ Time Frame: 1 year ]
    sensitivity from the 2x2 confusion matrix NSR vs 'non-NSR'

  3. Sensitivity of the cardiologists' classification in AF from the HWA09 ECG [ Time Frame: 1 year ]
    sensitivity from the 2x2 confusion matrix AF vs 'non-AF'

  4. Sensitivity of the cardiologists' classification in SR from the HWA09 ECG [ Time Frame: 1 year ]
    sensitivity from the 2x2 confusion matrix NSR vs 'non-NSR'

  5. Accuracy of the visibility of P-waves of single-lead ECG from HWA09 [ Time Frame: 1 year ]
    (true positives + true negatives)/(sample size) from the 2x2 confusion matrix

  6. Accuracy of the positivity of P-waves of single-lead ECG from HWA09 [ Time Frame: 1 year ]
    (true positives + true negatives)/(sample size) from the 2x2 confusion matrix

  7. Accuracy of the visibility of QRS-complexes of single-lead ECG from HWA09 [ Time Frame: 1 year ]
    (true positives + true negatives)/(sample size) from the 2x2 confusion matrix

  8. Accuracy of the positivity of QRS-complexes of single-lead ECG from HWA09 [ Time Frame: 1 year ]
    (true positives + true negatives)/(sample size) from the 2x2 confusion matrix

  9. Accuracy of the visibility of T-waves of single-lead ECG from HWA09 [ Time Frame: 1 year ]
    (true positives + true negatives)/(sample size) from the 2x2 confusion matrix

  10. Accuracy of the positivity of T-waves of single-lead ECG from HWA09 [ Time Frame: 1 year ]
    (true positives + true negatives)/(sample size) from the 2x2 confusion matrix

  11. RMSE between cardiologist's estimate of heart rate from the HWA09 single-lead ECG and the lead I reference ECG [ Time Frame: 1 year ]
    Root Mean Squared Error

  12. RMSE between cardiologist's estimate of heart rate from the HWA09 single-lead ECG and the heart rate calculated by ECG-SW1 [ Time Frame: 1 year ]
    Root Mean Squared Error



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Every eligible patient doing a medical examination at the investigation center will be asked to take part in the study.
Criteria

Inclusion Criteria:

  • Individuals over 18yo
  • Individuals who expressed their non-opposition to take part in the study
  • Individuals affiliated to a social security system or eligible

Exclusion Criteria:

  • Vulnerable individuals according to the regulation in force :

    • Pregnant, parturient or breastfeeding women
    • Individuals deprived of liberty by a court, medical or administrative order
    • Individuals under 18yo
    • Individuals legally protected or unable to express their non-opposition to take part in
    • Individuals unaffiliated to or not beneficiary of a social security system
    • Individuals who fit in multiple categories above
  • Individuals having refused to take part in the study
  • Individuals linguistically or mentally unable to express their non-opposition
  • Individuals physically unable to wear a watch
  • Individuals with an electrical pacing by a pacemaker

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04351386


Contacts
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Contact: David CAMPO +33 1 41 46 04 60 david.campo@withings.com
Contact: Julien NAHUM +33 1 49 33 48 75 j.nahum@ccn.fr

Locations
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France
Institut Cœur Paris Centre Turin Recruiting
Paris, Ile-de-France, France, 75008
Contact: David FOUASSIER    +33 6 08 52 66 67    david.fouassier@aphp.fr   
Principal Investigator: David FOUASSIER         
Hopital Europeen Georges Pompidou Suspended
Paris, Ile-de-France, France, 75015
Centre Cardiologique du Nord Suspended
Saint-Denis, Ile-de-France, France, 93200
Sponsors and Collaborators
Withings
Investigators
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Study Director: David CAMPO Withings
Principal Investigator: Julien NAHUM Centre Cardiologique du Nord
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Responsible Party: Withings
ClinicalTrials.gov Identifier: NCT04351386    
Other Study ID Numbers: 2019-A01476-51
First Posted: April 17, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual patient data (IPD) are considered as confidential in this study. After the end the final quality control, the database will be frozen and all the IPD will be archived .

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Withings:
Atrial Fibrillation
Arrythmia, Cardiac
Cardiovascular Disease
Heart Disease
Wearable Electronic Device
Watch
Electrocardiography
ECG
Photoplethysmography
PPG
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes