Back to resultsClinical Validation of the Withings ECG Monitor for the Detection of Atrial Fibrillation (QDA-UE)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Validation of the Withings bodyscan scale WBS08
Sponsored by
About this trial
This is an interventional diagnostic trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- 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.
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 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)
- 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
Sites / Locations
- Cliniques Universitaires de Bruxelles - Hôpital Erasme
- Henri Mondor University Hospital
- Poitiers University Hospital
- George Pompidou European Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Withings WBS08 and 12-lead reference ECG
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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 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
Assessment of the 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.
Assessment of the 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 on the first beat of the 6 marked PQRST complexes 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.
Determination of the heart rate
The 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 strip of the reference ECG. For each simultaneous pair of strips, a reviewer will independently select a common lead with the best signal quality. Then, the reviewer will determine one or several window(s) on the selected lead according to a set of predetermined rules. Finally the number N of complete RR intervals inside these windows and the duration Dt (< 30s) of the windows will be measured with a caliper. The heart rate will then be calculated as 60*N/Dt. The reader-estimated heart rates will later be compared to the heart rates calculated by the SUT
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05266235
Brief Title
Clinical Validation of the Withings ECG Monitor for the Detection of Atrial Fibrillation
Acronym
QDA-UE
Official Title
Clinical Validation of the Withings ECG Monitor for the Detection of Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 14, 2022 (Actual)
Primary Completion Date
July 28, 2022 (Actual)
Study Completion Date
July 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Withings
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
Patients included will be those presenting for consultation in the various participating clinical services. For each patient, an ECG will be recorded with the WBS08 and with the reference device Cardiovit FT1, at rest and after an exercise session.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
274 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Withings WBS08 and 12-lead reference ECG
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Validation of the Withings bodyscan scale WBS08
Intervention Description
Participants will undergo simultaneous recordings of ECGs with the comparator and the study device
Primary Outcome Measure Information:
Title
Performance in the identification of atrial fibrillation and sinus rhythm
Description
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.
Time Frame
10 months
Secondary Outcome Measure Information:
Title
Evaluation of the classification into heart rate subgroups
Description
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 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
Time Frame
10 months
Title
Assessment of the clinical equivalence of ECG waveforms
Description
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.
Time Frame
10 months
Title
Assessment of the clinical equivalence of ECG waveforms
Description
The durations of the QT intervals, QRS complex widths, and PR intervals will be measured by cardiologists with a caliper on the first beat of the 6 marked PQRST complexes 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.
Time Frame
10 months
Title
Determination of the heart rate
Description
The 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 strip of the reference ECG. For each simultaneous pair of strips, a reviewer will independently select a common lead with the best signal quality. Then, the reviewer will determine one or several window(s) on the selected lead according to a set of predetermined rules. Finally the number N of complete RR intervals inside these windows and the duration Dt (< 30s) of the windows will be measured with a caliper. The heart rate will then be calculated as 60*N/Dt. The reader-estimated heart rates will later be compared to the heart rates calculated by the SUT
Time Frame
10 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
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 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)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Lellouche, MD
Organizational Affiliation
Henri Mondor University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques Universitaires de Bruxelles - Hôpital Erasme
City
Brussel
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Henri Mondor University Hospital
City
Créteil
State/Province
Val De Marne
ZIP/Postal Code
94000
Country
France
Facility Name
Poitiers University Hospital
City
Poitiers
State/Province
Vienne
ZIP/Postal Code
86021
Country
France
Facility Name
George Pompidou European Hospital
City
Paris
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Validation of the Withings ECG Monitor for the Detection of Atrial Fibrillation
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