Status:
COMPLETED
Atrial Fibrillation Algorithms Clinical Validation Study
Lead Sponsor:
Apple Inc.
Collaborating Sponsors:
Iqvia Pty Ltd
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
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.
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2021
Estimated Enrollment :
573 Patients enrolled
Trial Details
Trial ID
NCT04699812
Start Date
November 16 2020
End Date
December 17 2021
Last Update
August 24 2022
Active Locations (4)
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1
Clinical Research of South Florida
Coral Gables, Florida, United States, 33134
2
American Health Network of Indiana Llc
Avon, Indiana, United States, 46123
3
Heartland Cardiology Webb
Wichita, Kansas, United States, 67226
4
Healtheast
Saint Paul, Minnesota, United States, 55012