WIBOFA - Validation of SCT02 With ECG-App for Detection of AF

Description

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

Conditions

Atrial Fibrillation

Study Overview

Study Details

Study overview

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

Validation of Withings BeamO With Withings ECG-App for the Detection of Atrial Fibrillation

WIBOFA - Validation of SCT02 With ECG-App for Detection of AF

Condition
Atrial Fibrillation
Intervention / Treatment

-

Contacts and Locations

Boca Raton

FWD Clinical Research, Boca Raton, Florida, United States, 33486

Miami

Diverse Clinical Research, Miami, Florida, United States, 33175

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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).

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Withings,

Study Record Dates

2025-06-01