Atrial Fibrillation Algorithms Clinical Validation Study

Inclusion Criteria

• Able to read, understand, and provide written informed consent
• Willing and able to participate in the study procedures as described in the consent form
• Be 22 years of age and older
• Able to communicate effectively with and follow instructions from the study staff
• Able to wear the wrist device for duration of study participation
• For Cohort 1, have no known medical history of AF
• For Cohort 2, have no known medical history of AF and active diagnosis of at least one of the following arrhythmias within the past 2 years:
• Frequent PACs, defined as at least 1% of total beats of atrial ectopic beats by 24-48 hour Holter, ambulatory ECG monitor, or implantable loop recorder)
• Frequent PVCs, defined as at least 1% of total beats of ventricular ectopic beats by 24-48 hour Holter, ambulatory ECG monitor, or implantable loop recorder
• SVT, which will include atrial tachycardia, atrioventricular nodal re-entrant tachycardia, atrioventricular re-entrant tachycardia by 12-lead ECG or 24-48 hour Holter, ambulatory ECG monitor, or implantable loop recorder
• NSVT, defined as three or more consecutive ventricular beats at a rate of at least 100 beats per minute and lasting no more than 30 seconds, by 12-lead ECG or 24-48 hour Holter, ambulatory ECG monitor, or implantable loop recorder
• For Cohorts 3 and 4, have a known diagnosis of AF at the time of screening (confirmed by electronic medical record (EMR) or self-report) and have had a recent episode of AF, or confirmed AF on ECG, in the past 12 months
• For Cohort 4, have a known diagnosis of permanent AF at the time of screening (confirmed by EMR or self-report) and have had a recent episode of AF, or confirmed AF on ECG, in the past 12 months
• Meet additional binning based on demographics.

Exclusion Criteria

• Physical disability that precludes safe and adequate testing
• Mental impairment resulting in limited ability to cooperate
• Known uncontrolled medical conditions, such as (but not limited to) significant anemia, important electrolyte imbalance and untreated or uncontrolled thyroid disease
• Open wound(s) on the wrist and/or forearm
• Tattoos, large moles, or scars on the wrist at the wrist device location
• Skin conditions on either wrist that would preclude subject from wearing a wristband on either wrist
• Known allergy or sensitivity to medical adhesives, isopropyl alcohol, wristbands, or ECG patch
• Medical history or physical assessment finding that makes the subject inappropriate for participation according to investigator(s)
• Participation in a previous study that used a wrist-worn sensor device with a simultaneous ECG reference patch
• Implantable cardiac devices such as a Pacemaker or Implantable Cardioverter Defibrillator
• Clinically significant hand tremors, as judged by the investigator
• Acute illness including COVID and other respiratory illnesses
• Subjects with known history of AF on rhythm control medications with history of complete AF rhythm control (i.e history of zero AF burden) will be excluded from Cohorts 3 and 4