Clinical trial NCT06351761: WIBOFA - Validation of SCT02 With ECG-App for Detection of AF
Official title: Validation of Withings BeamO With Withings ECG-App for the Detection of Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Withings
Sponsor class: INDUSTRY
First posted: 2024-04-08
Enrollment: 371
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to evaluate the performance of Withings SCT02 with embedded Withings ECG-app 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:

* Subject with an implanted electrical device (i.e. pacemaker, ICD ...), whether active or inactive
* Pathologic disorders that may affect motricity resulting in significant hands tremor that prevents subject from being able to hold still (e.g. Parkinson disease)
* Myocardial Infarction (MI) within 90 days prior to the enrollment
* Pulmonary embolism or pulmonary infarction within 90 days prior to the enrollment
* Stroke or Transient Ischemic Attack (TIA) within 90 days prior to the enrollment
* Active or history of life-threatening rhythms as determined by investigators (e.g. ventricular tachycardia, ventricular fibrillation, 3rd degree heart block)
* Any cardiovascular disease that investigators would consider as a risk to subject or renders data uninterpretable (e.g. recent or ongoing unstable angina, decompensated heart failure, active myocarditis or pericarditis)
* Active or symptomatic skin disease on Schiller electrode attachment sites or fingertips which would be in contact with BeamO electrodes (e.g. eczema, rosacea, impetigo, dermatomyositis or allergic contact dermatitis)
* Known sensitivity to medical adhesives, isopropyl alcohol,, electrocardiogram (ECG) electrodes, including known allergy or sensitivity to stainless steel (used in BeamO electrodes).

Primary outcomes:
measure: Co-primary outcome 1 - Sensitivity of Investigational Device
timeFrame: 10 months
measure: Co-primary outcome 2 - Specificity of Investigational Device
timeFrame: 10 months
Secondary outcomes:
measure: Rhythm classification by ranges of heart rate
timeFrame: 10 months
measure: Quality of plots measured by the IMD - ECG Waveform Visibility
timeFrame: 10 months
measure: Quality of plots measured by the IMD - ECG Waveforms Polarity
timeFrame: 10 months
measure: Quality of plots measured by the IMD - ECG Waveforms Intervals
timeFrame: 10 months
measure: Quality of plots measured by the IMD - Heart Rate calculation
timeFrame: 10 months
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: FWD Clinical Research
state: Florida
city: Miami
country: United States
facility: Diverse Clinical Research
state: Florida
city: Créteil
country: France
facility: Henri Mondor University Hospital
state: Val De Marne
city: Paris
country: France
facility: Centre Cardiopole Trubert
Study officials:
References: