Withings ECG-Monitor Study

Last updated: March 18, 2024
Sponsor: Withings
Overall Status: Completed

Phase

N/A

Condition

Dysrhythmia

Chest Pain

Arrhythmia

Treatment

Electrocardiogram recording

Clinical Study ID

NCT05316337
WBS08-ECG
  • Ages > 22
  • All Genders

Study Summary

The aim of the study is to evaluate the performance of Withings WBS08 with embedded Withings ECG Monitor in the automatic detection of atrial fibrillation

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female who are 22 years of age or older,
  • Subject able to read, understand, and provide written informed consent,
  • Subject willing and able to participate in the study procedures as described in theconsent form,
  • Subject able to communicate effectively with and willing to follow instructions fromthe study staff.

Exclusion

Exclusion Criteria:

  • Vulnerable subject with regard to regulations in force
  • Subject who is deprived of liberty by judicial, medical or administrativedecision,
  • Underage subject,
  • Legally protected subject, or subject who is unable, linguistic or psychicincapacity, to sign the written informed consent form.
  • Subject within several of the above categories,
  • Subject who refused to participate in the study,
  • Subject mentally impaired resulting in limited ability to cooperate
  • Subject with electrical stimulation by pacemaker
  • Patient with pathologic disorder that may affect motricity resulting in significanttremor that prevents subject from being able to hold still (e.g Parkinson disease)
  • Patient unable to stay in an upright position for the duration of study measures
  • Acute myocardial infarction (MI) within 90 days of screening or other cardiovasculardisease that, in the opinion of the Investigator, may increase the risk to the subjector renders data uninterpretable (e.g., recent or ongoing unstable angina,decompensated heart failure, active myocarditis or pericarditis)
  • Acute pulmonary embolism or pulmonary infarction, within 90 days of screening
  • Stroke or transient ischemic attack within 90 days of screening
  • Active life-threatening rhythms as determined by the investigator (ventriculartachycardia, ventricular fibrillation, 3 rd -degree heart block).
  • History of life-threatening rhythms as determined by the investigator (ventriculartachycardia, ventricular fibrillation, 3 rd -degree heart block)
  • Symptomatic (or active) allergic skin reactions such as eczema, rosacea, impetigo,dermatomyositis or allergic contact dermatitis over electrode attachment sites
  • Known sensitivity to medical adhesives, isopropyl alcohol, or electrocardiogram (ECG)electrodes including known allergy or sensitivity to fluoroelastomer bands
  • Weight more than 180 kg

Study Design

Total Participants: 650
Treatment Group(s): 1
Primary Treatment: Electrocardiogram recording
Phase:
Study Start date:
July 15, 2022
Estimated Completion Date:
September 01, 2023

Connect with a study center

  • Henri-Mondor Hospital

    Créteil, Île De France 94000
    France

    Site Not Available

  • FWD Clinical Research

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Florida Cardiovascular Research

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Diverse Clinical Research

    Miami, Florida 33175
    United States

    Site Not Available

  • The Angel Medical Research

    Miami Lakes, Florida 33016
    United States

    Site Not Available

  • American Institute of Therapeutics

    Lake Bluff, Illinois 60044
    United States

    Site Not Available

  • Cambridge Medical Trials

    Alexandria, Louisiana 71301
    United States

    Site Not Available

  • Heartbeat Health

    New York, New York 10019
    United States

    Site Not Available

  • Texas Heart Institute

    Houston, Texas 77030
    United States

    Site Not Available

  • LINQ Research LLC

    Pearland, Texas 77584
    United States

    Site Not Available

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