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Clinical Performance of Withings Move ECG Software for Atrial Fibrillation Detection (ECG-SW1)

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: NCT04493749
Recruitment Status : Recruiting
First Posted : July 30, 2020
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Withings

Brief Summary:
Withings Move ECG watch is designed to record ECG and detect automatically atrial fibrillation. The aim of this study is to validate the performance of Move ECG watch to detect atrial fibrillation compared to a reference 12-lead ECG.

Condition or disease Intervention/treatment
Atrial Fibrillation Diagnostic Test: ECG measurement

Detailed Description:

Patients with atrial fibrillation are included in hospitals. On each patient, ECG with Move ECG and the reference 12-lead ECG are recorded simultaneously. Both records are then reviewed by independent cardiologists to assess

  1. The presence or absence of atrial fibrillation
  2. if waveforms of ECG recorded with Move ECG compared with the reference.

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Study Type : Observational
Estimated Enrollment : 234 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Performance of Withings Move ECG Software for Atrial Fibrillation Detection
Actual Study Start Date : December 20, 2019
Estimated Primary Completion Date : October 15, 2020
Estimated Study Completion Date : October 15, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
atrial fibrillation (AF)
Patients diagnosed with AF during reference ECG
Diagnostic Test: ECG measurement
Simultaneous recording of a single-lead ECG signal with the Withings Move ECG and ECG signal for the reference 12-lead ECG

sinus rhythm (SR)
Patients diagnosed with SR during reference ECG
Diagnostic Test: ECG measurement
Simultaneous recording of a single-lead ECG signal with the Withings Move ECG and ECG signal for the reference 12-lead ECG




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


Secondary Outcome Measures :
  1. Comparability of ECG waveforms from single strip of Move ECG vs Lead-1 of reference 12-lead ECG [ Time Frame: 1 year ]
    Visibility and polarity of P waves, QRS complex and T waves + length of QT interval, QRS width and PR interval + heart rate

  2. Safety of use of Move ECG [ Time Frame: 1 year ]
    Frequency of adverse event appearance



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
in and out patients from cardiology services
Criteria

Inclusion Criteria:

  • male or female who are 18 years or older
  • Subject who signed the written informed consent form

Exclusion Criteria:

  • Vulnerable subject with regard to regulations
  • Pregnant, parturient or breastfeeding woman,
  • Subject who is deprived of liberty by judicial, medical or administrative decision,
  • Underage subject,
  • Legally protected subject, or subject who is unable to sign the written informed consent form,
  • Subject who is not beneficiary or not affiliated to a social security scheme,
  • Subject within several of the above categories,
  • Subject who refused to participate in the study,
  • Subject in physical incapacity to wear a wrist-worn watch
  • Subject with electrical stimulation by 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): NCT04493749


Contacts
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Contact: Delphine Ladarré +33 6 75 12 23 80 delphine.ladarre@withings.com
Contact: Rui Yi Yang +33 6 19 78 25 54 ruiyi.yang@withings.com

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   
Hopital Europeen Georges Pompidou Completed
Paris, Ile-de-France, France, 75015
Centre Cardiologique du Nord Completed
Saint-Denis, Ile-de-France, France, 93200
Sponsors and Collaborators
Withings
Investigators
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Principal Investigator: Julien Nahum Centre Cardiologique du Nord
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Responsible Party: Withings
ClinicalTrials.gov Identifier: NCT04493749    
Other Study ID Numbers: 2019-A013-58-49
First Posted: July 30, 2020    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes