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Validation Study of WITHINGS BPM Core for the Detection of Atrial Fibrillation (Core AF)

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: NCT04464499
Recruitment Status : Recruiting
First Posted : July 9, 2020
Last Update Posted : July 28, 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 electrocardiographic function of the BPM Core developed by Withings for the automatic identification of atrial fibrillation (AF).

Condition or disease Intervention/treatment
Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Diagnostic Test: ECG measurement

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation Study of WITHINGS BPM Core for the Detection of Atrial Fibrillation
Actual Study Start Date : July 6, 2020
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 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 BPM Core 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 BPM Core and ECG signal for the reference 12-lead ECG




Primary Outcome Measures :
  1. Sensitivity of the automatic classification in AF by BPM Core 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 AF by BPM Core 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 cardiologists' classification in AF from the BPM Core ECG [ Time Frame: 1 year ]
    sensitivity from the 2x2 confusion matrix AF vs 'non-AF'

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

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

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

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

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

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

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (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,
  • Able to communicate effectively with and follow instructions from the study staff
  • Person with an arm circumference between 22 and 42 cm

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 linguistic or psychic incapacity to sign a written informed consent form,
  • Subject in physical incapacity to wear a blood pressure monitor
  • Subject with electrical stimulation by pacemaker
  • Significant tremor that prevents subject from being able to hold still
  • Known sensitivity to medical adhesives, isopropyl alcohol, or ECG electrodes

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): NCT04464499


Contacts
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Contact: David Campo, PhD +33 1 41 46 04 60 david.campo@withings.com
Contact: David Campo, MD fouassier@icpc.fr

Locations
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France
ICPC Floréale Recruiting
Bagnolet, France, 93170
Contact: Adrien Pasteur-Rousseau, MD       adrien.pasteur@gmail.com   
ICPC Turin Recruiting
Paris, France, 75004
Contact: David Fouassier, MD       fouassier@icpc.fr   
Sponsors and Collaborators
Withings
Investigators
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Study Director: David Campo, PhD Withings
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Responsible Party: Withings
ClinicalTrials.gov Identifier: NCT04464499    
Other Study ID Numbers: 2019-A03346-51
First Posted: July 9, 2020    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 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
arrhythmia, cardiac
cardiovascular disease
heart disease
wearable electronic device
ECG
blood pressure monitor
electrocardiography
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes