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

NCT04351386 | Completed

• 1 other identifier: 2019-A01476-51
• Study Type: observational
• Target: 283
• Locations: 1 country
• Sites: 3

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).

Conditions

Atrial Fibrillation; Arrythmia, Cardiac

Keywords

Atrial Fibrillation; Arrythmia, Cardiac; Cardiovascular Disease; Heart Disease; Wearable Electronic Device; Watch; Electrocardiography; ECG; Photoplethysmography; PPG

Outcome Measures

Primary Outcomes (2)

• Sensitivity of the automatic classification in AF by ECG-SW1 of HWA09 single-lead ECG against reference 12-lead ECG

  sensitivity from the 2x2 confusion matrix AF vs 'non-AF'

  1 year

• Sensitivity of the automatic classification in NSR by ECG-SW1 of HWA09 single-lead ECG against reference 12-lead ECG

  sensitivity from the 2x2 confusion matrix NSR vs 'non-NSR'

  1 year

Secondary Outcomes (12)

• Sensitivity of the automatic classification in AF by PPG-SW1 of the HWA09 PPG against reference 12-lead ECG

  1 year

• Sensitivity of the automatic classification in NSR by PPG-SW1 of the HWA09 PPG against reference 12-lead ECG

  1 year

• Sensitivity of the cardiologists' classification in AF from the HWA09 ECG

  1 year

• Sensitivity of the cardiologists' classification in SR from the HWA09 ECG

  1 year

• Accuracy of the visibility of P-waves of single-lead ECG from HWA09

  1 year

Study Arms (3)

Atrial Fibrillation (AF)

Patients diagnosed with AF during reference ECG

Device: AF Detection

Normal Sinus Rhythm (NSR)

Patients with NSR during reference ECG

Device: AF Detection

Other Arrythmia

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

Device: AF Detection

Interventions

AF Detection DEVICE

Recording PPG and single-lead ECG signals with the Withings HWA09 and ECG signal for the reference 12-lead ECG

Atrial Fibrillation (AF); Normal Sinus Rhythm (NSR); Other Arrythmia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Withings: lead

Study Sites (3)

Institut Cœur Paris Centre Turin

Paris, Île-de-France Region, 75008, France

Location

Hopital Europeen Georges Pompidou

Paris, Île-de-France Region, 75015, France

Location

Centre Cardiologique du Nord

Saint-Denis, Île-de-France Region, 93200, France

Location

Related Publications (1)

• Campo D, Elie V, de Gallard T, Bartet P, Morichau-Beauchant T, Genain N, Fayol A, Fouassier D, Pasteur-Rousseau A, Puymirat E, Nahum J. Atrial Fibrillation Detection With an Analog Smartwatch: Prospective Clinical Study and Algorithm Validation. JMIR Form Res. 2022 Nov 4;6(11):e37280. doi: 10.2196/37280.

  PMID: 35481559 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac; Cardiovascular Diseases; Heart Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David CAMPO

  Withings

  STUDY DIRECTOR

• Julien NAHUM

  Centre Cardiologique du Nord

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 17, 2020
• Study Start: December 20, 2019
• Primary Completion: April 7, 2021
• Study Completion: April 7, 2021
• Last Updated: November 16, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)