Atrial Fibrillation Algorithms Clinical Validation Study

Completed · Not applicable

Conditions studied: Atrial Fibrillation

In brief

The purpose of the study is to evaluate the performances of investigational Irregular Rhythm Notification Feature (version 2.0) and Atrial Fibrillation History Feature algorithms.

Key facts

Study ID: NCT04699812
Run by: Apple Inc.
People needed: 573
Starts: 2020-11-16
Expected to finish: 2021-12-17
Last updated by the study team: 2022-08-24

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Clinical Research of South Florida — Coral Gables, Florida, United States
American Health Network of Indiana Llc — Avon, Indiana, United States
Heartland Cardiology Webb — Wichita, Kansas, United States
Healtheast — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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