Clinical Validation of the Withings ECG Monitor for the Detection of Atrial Fibrillation

NCT05266235 | Completed

• 1 other identifier: 2021-A02730-41
• Study Type: interventional
• Target: 274
• Locations: 2 countries
• Sites: 4

Brief Summary

The aim of the study is to demonstrate the performance of Withings WBS08 in the automatic identification of atrial fibrillation and sinus rhythm.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Performance in the identification of atrial fibrillation and sinus rhythm

  The co-primary endpoints are the sensitivity and specificity 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.

  10 months

Secondary Outcomes (4)

• Evaluation of the classification into heart rate subgroups

  10 months

• Assessment of the clinical equivalence of ECG waveforms

  10 months

• Assessment of the clinical equivalence of ECG waveforms

  10 months

• Determination of the heart rate

  10 months

Study Arms (1)

Withings WBS08 and 12-lead reference ECG

EXPERIMENTAL

The electrodes of the 12-lead ECG will be set up on the participants, before they step on withings WBS08 to have ECGs simultaneously recorded by the study device and the control device

Device: Validation of the Withings bodyscan scale WBS08

Interventions

Validation of the Withings bodyscan scale WBS08 DEVICE

Participants will undergo simultaneous recordings of ECGs with the comparator and the study device

Withings WBS08 and 12-lead reference ECG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female who are 18 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
• Subject affiliated to a social security system
• For subjects enrolled into the AF population, subjects must have a known diagnosis of AF and be in AF at the time of screening. Subjects may have any type of AF including paroxysmal, persistent, and permanent AF.

You may not qualify if:

• 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 a pacemaker, ICD (Implantable cardioverter defibrillator) or other implanted electronic stimulator
• Patient with pathologic disorder that may affect motricity resulting in significant tremor that prevents subject from being ablle 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, 3rd degree heart block).
• History of abnormal life-threatening rhythms as determined by the investigator (e.g., ventricular tachycardia, ventricular fibrillation, 3rd degree heart block)

Sponsors & Collaborators

• Withings: lead

Study Sites (4)

Cliniques Universitaires de Bruxelles - Hôpital Erasme

Brussels, 1070, Belgium

Location

Henri Mondor University Hospital

Créteil, Val De Marne, 94000, France

Location

Poitiers University Hospital

Poitiers, Vienne, 86021, France

Location

George Pompidou European Hospital

Paris, 75015, France

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicolas Lellouche, MD

  Henri Mondor University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: March 4, 2022
• Study Start: April 14, 2022
• Primary Completion: July 28, 2022
• Study Completion: July 28, 2022
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3); BE (1)