Withings ECG-Monitor Study

NCT05316337 | Completed FDA Device

• 1 other identifier: WBS08-ECG
• Study Type: interventional
• Target: 650
• Locations: 2 countries
• Sites: 10

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

Conditions

Atrial Fibrillation

Keywords

mHealth; Atrial fibrillation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Evaluation of the classification into heart rate subgroups

  4 months

• Clinical Equivalence of ECG waveforms

  4 months

• Clinical Equivalence of ECG waveforms

  4 months

• Heart Rate equivalence

  4 months

Study Arms (2)

Atrial fibrillation

EXPERIMENTAL

Device: Electrocardiogram recording

Normal Sinus Rhythm

EXPERIMENTAL

Device: Electrocardiogram recording

Interventions

Electrocardiogram recording DEVICE

ECG recording with investigational device

Atrial fibrillation; Normal Sinus Rhythm

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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 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)

Sponsors & Collaborators

• Withings: lead
• Syntactx: collaborator

Study Sites (10)

FWD Clinical Research

Boca Raton, Florida, 33486, United States

Location

Florida Cardiovascular Research

Hialeah, Florida, 33012, United States

Location

Diverse Clinical Research

Miami, Florida, 33175, United States

Location

The Angel Medical Research

Miami Lakes, Florida, 33016, United States

Location

American Institute of Therapeutics

Lake Bluff, Illinois, 60044, United States

Location

Cambridge Medical Trials

Alexandria, Louisiana, 71301, United States

Location

Heartbeat Health

New York, New York, 10019, United States

Location

Texas Heart Institute

Houston, Texas, 77030, United States

Location

LINQ Research LLC

Pearland, Texas, 77584, United States

Location

Henri-Mondor Hospital

Créteil, Île-de-France Region, 94000, 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

• Jeffrey Wessler, MD

  Heartbeat Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: April 7, 2022
• Study Start: July 15, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (9); FR (1)