Clinical trial NCT05316337: Withings ECG-Monitor Study
Official title: Validation of WBS08 With Withings ECG Monitor for the Detection of Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: mHealth
Atrial fibrillation
Lead sponsor: Withings
Sponsor class: INDUSTRY
Collaborators: name: Syntactx
First posted: 2022-04-07
Enrollment: 650
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


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

Primary outcomes:
measure: Co-primary outcomes
timeFrame: 4 months
measure: Co-primary outcomes
timeFrame: 4 months
Secondary outcomes:
measure: Evaluation of the classification into heart rate subgroups
timeFrame: 4 months
measure: Clinical Equivalence of ECG waveforms
timeFrame: 4 months
measure: Clinical Equivalence of ECG waveforms
timeFrame: 4 months
measure: Heart Rate equivalence
timeFrame: 4 months
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: FWD Clinical Research
state: Florida
city: Hialeah
country: United States
facility: Florida Cardiovascular Research
state: Florida
city: Miami Lakes
country: United States
facility: The Angel Medical Research
state: Florida
city: Miami
country: United States
facility: Diverse Clinical Research
state: Florida
city: Lake Bluff
country: United States
facility: American Institute of Therapeutics
state: Illinois
city: Alexandria
country: United States
facility: Cambridge Medical Trials
state: Louisiana
city: New York
country: United States
facility: Heartbeat Health
state: New York
city: Houston
country: United States
facility: Texas Heart Institute
state: Texas
city: Pearland
country: United States
facility: LINQ Research LLC
state: Texas
city: Créteil
country: France
facility: Henri-Mondor Hospital
state: Île De France
Study officials:
affiliation: Heartbeat Health
name: Jeffrey Wessler, MD
role: PRINCIPAL_INVESTIGATOR
References: