Status:
COMPLETED
Withings ECG-Monitor Study
Lead Sponsor:
Withings
Collaborating Sponsors:
Syntactx
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
22+ years
Phase:
NA
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
- 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
- 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
Key Trial Info
Start Date :
July 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2023
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT05316337
Start Date
July 15 2022
End Date
September 1 2023
Last Update
March 20 2024
Active Locations (10)
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1
FWD Clinical Research
Boca Raton, Florida, United States, 33486
2
Florida Cardiovascular Research
Hialeah, Florida, United States, 33012
3
Diverse Clinical Research
Miami, Florida, United States, 33175
4
The Angel Medical Research
Miami Lakes, Florida, United States, 33016