Withings ECG-Monitor Study

Validation of WBS08 With Withings ECG Monitor for the Detection of Atrial Fibrillation

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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Electrocardiogram recording; Device: Electrocardiogram recording

• Study Type: Interventional
• Enrollment (Actual): 650
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Île De France
    • Créteil, Île De France, France, 94000
      • Henri-Mondor Hospital
• United States
  • Florida
    • Boca Raton, Florida, United States, 33486
      • FWD Clinical Research
    • Hialeah, Florida, United States, 33012
      • Florida Cardiovascular Research
    • Miami, Florida, United States, 33175
      • Diverse Clinical Research
    • Miami Lakes, Florida, United States, 33016
      • The Angel Medical Research
  • Illinois
    • Lake Bluff, Illinois, United States, 60044
      • American Institute of Therapeutics
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • Cambridge Medical Trials
  • New York
    • New York, New York, United States, 10019
      • Heartbeat Health
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Heart Institute
    • Pearland, Texas, United States, 77584
      • LinQ Research LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 the consent form,
• Subject able to communicate effectively with and willing to follow instructions from the study staff.

Exclusion Criteria:

• Vulnerable subject with regard to regulations in force

  • Subject who is deprived of liberty by judicial, medical or administrative decision,
  • Underage subject,
  • Legally protected subject, or subject who is unable, linguistic or psychic incapacity, 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 significant tremor 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 cardiovascular disease that, in the opinion of the Investigator, may increase the risk to the subject or 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 (ventricular tachycardia, ventricular fibrillation, 3 rd -degree heart block).
• History of life-threatening rhythms as determined by the investigator (ventricular tachycardia, 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal Sinus Rhythm	Device: Electrocardiogram recording; ECG recording with investigational device; Device: Electrocardiogram recording; ECG recording with reference device
Experimental: Atrial fibrillation	Device: Electrocardiogram recording; ECG recording with investigational device; Device: Electrocardiogram recording; ECG recording with reference device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Co-primary outcomes	Sensitivity (percentage of true positives) in detecting AF from conclusive recordings generated by the software under test, that is recordings resulting in a classification of AF or SR by the SUT, compared to the reference 12-lead ECG.	4 months
Co-primary outcomes	Specificity (percentage of true negatives) in detecting AF from conclusive recordings generated by the software under test, that is recordings resulting in a classification of AF or SR by the SUT, compared to the reference 12-lead ECG.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the classification into heart rate subgroups	The classification into heart rate subgroups will be evaluated for the pairs of strips such that the rhythm classification of the 12-lead ECG is either SR or AF and such that the strip generated by the SUT is classified as either SR or AF. The evaluation will be assessed with the concordance of classifications, i.e. the percentage P of identical classifications by the SUT and the reference method, into each of the four following subgroups: SR with a HR between 50 and 99 bpm; SR with a HR between 100 and 150 bpm; AF with a HR between 50 and 99 bpm; AF with a HR between 100 and 150 bpm	4 months
Clinical Equivalence of ECG waveforms	Clinical Equivalence of ECG waveforms will be qualitatively and quantitatively assessed between the 6-leads generated by the SUT and the leads I, II, III, aVR, aVL, aVF of the 12-lead ECG by a board of certified cardiologists: The visibility and polarity of the P waves, QRS complexes and T waves will be determined by cardiologists and according to a set of predetermined rules. For each type of wave (P, QRS and T),	4 months
Clinical Equivalence of ECG waveforms	The durations of the QT intervals, QRS complex widths, and PR intervals will be measured by cardiologists with a caliper and according to a set of predetermined rules for each of the 6 leads of the strips generated by the SUT and the leads I, II, III, aVR, aVL, aVF of the 12-lead ECG.	4 months
Heart Rate equivalence	heart rate will be determined by independent cardiologists, or cardiac technicians supervised by cardiologists, from each six-channel strip recorded with the SUT and from each lead I, II, III, aVR, aVL, aVF of the 12-lead reference ECG	4 months

Collaborators and Investigators

• Sponsor: Withings
• Collaborators: Syntactx
• Investigators: Principal Investigator: Jeffrey Wessler, MD, Heartbeat Health

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: March 18, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Atrial fibrillation; mHealth
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: WBS08-ECG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No