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Withings ECG-Monitor Study

Primary Purpose

Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Electrocardiogram recording
Electrocardiogram recording
Sponsored by
Withings
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Atrial Fibrillation focused on measuring mHealth, Atrial fibrillation

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • FWD Clinical ResearchRecruiting
  • Florida Cardiovascular ResearchRecruiting
  • The Angel Medical ResearchRecruiting
  • Diverse Clinical ResearchRecruiting
  • American Institute of TherapeuticsRecruiting
  • Cambridge Medical TrialsRecruiting
  • Heartbeat HealthRecruiting
  • Texas Heart InstituteRecruiting
  • LINQ Research LLCRecruiting
  • Henri-Mondor HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Atrial fibrillation

Normal Sinus Rhythm

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

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. 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
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),
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.
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

Full Information

First Posted
March 18, 2022
Last Updated
August 10, 2023
Sponsor
Withings
Collaborators
Syntactx
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1. Study Identification

Unique Protocol Identification Number
NCT05316337
Brief Title
Withings ECG-Monitor Study
Official Title
Validation of WBS08 With Withings ECG Monitor for the Detection of Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Withings
Collaborators
Syntactx

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
mHealth, Atrial fibrillation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
632 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atrial fibrillation
Arm Type
Experimental
Arm Title
Normal Sinus Rhythm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Electrocardiogram recording
Intervention Description
ECG recording with investigational device
Intervention Type
Device
Intervention Name(s)
Electrocardiogram recording
Intervention Description
ECG recording with reference device
Primary Outcome Measure Information:
Title
Co-primary outcomes
Description
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.
Time Frame
4 months
Title
Co-primary outcomes
Description
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.
Time Frame
4 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. 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
4 months
Title
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. For each type of wave (P, QRS and T),
Time Frame
4 months
Title
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 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
4 months
Title
Heart Rate equivalence
Description
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
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Campo, PhD
Phone
+33 1.41.46.04.60
Email
david.campo@withings.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Wessler, MD
Organizational Affiliation
Heartbeat Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
FWD Clinical Research
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esthefany Jabbour
Email
esthefany@fwdclinical.com
First Name & Middle Initial & Last Name & Degree
Michael Cammarata, MD
Facility Name
Florida Cardiovascular Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Email
ketia@floridavresearch.com
First Name & Middle Initial & Last Name & Degree
Pablo Guala, MD
Facility Name
The Angel Medical Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordiator
Email
leadcoordinator@theangelresearch.com
First Name & Middle Initial & Last Name & Degree
John Dylewski, MD
Facility Name
Diverse Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S Cuba
First Name & Middle Initial & Last Name & Degree
Mireya Garcia, MD
Facility Name
American Institute of Therapeutics
City
Lake Bluff
State/Province
Illinois
ZIP/Postal Code
60044
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Somberg, MD
Email
johnsomberg1@comcast.net
First Name & Middle Initial & Last Name & Degree
John Somberg, MD
Facility Name
Cambridge Medical Trials
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naseem Jaffrani, MD
First Name & Middle Initial & Last Name & Degree
Naseem Jaffrani, MD
Facility Name
Heartbeat Health
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Wessler, MD
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Email
clinical@heartbeathealth.com
First Name & Middle Initial & Last Name & Degree
Jeffrey Wessler, MD
Facility Name
Texas Heart Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Email
hpetaway@texasheart.org
First Name & Middle Initial & Last Name & Degree
Alex Postilian, MD
Facility Name
LINQ Research LLC
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator, MD
Phone
281-984-4358
First Name & Middle Initial & Last Name & Degree
Andres Vasquez, MD
Facility Name
Henri-Mondor Hospital
City
Créteil
State/Province
Île De France
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Pascal Lefaucheur, Pr
Phone
+ 33 (0)1 49 81 26 77
Email
jean-pascal.lefaucheur@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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