Clinical trial NCT04699812: Atrial Fibrillation Algorithms Clinical Validation Study
Official title: Atrial Fibrillation Algorithms Clinical Validation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: CARDIOVASCULAR DISEASES
HEART DISEASES
ARRHYTHMIA
CARDIAC
Lead sponsor: Apple Inc.
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2021-01-07
Enrollment: 573
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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 Criteria:

1. Able to read, understand, and provide written informed consent
2. Willing and able to participate in the study procedures as described in the consent form
3. Be 22 years of age and older
4. Able to communicate effectively with and follow instructions from the study staff
5. Able to wear the wrist device for duration of study participation
6. For Cohort 1, have no known medical history of AF
7. 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:

   1. 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)
   2. 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
   3. 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
   4. 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
8. 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
9. 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
10. Meet additional binning based on demographics.

Exclusion Criteria:

1. Physical disability that precludes safe and adequate testing
2. Mental impairment resulting in limited ability to cooperate
3. Known uncontrolled medical conditions, such as (but not limited to) significant anemia, important electrolyte imbalance and untreated or uncontrolled thyroid disease
4. Open wound(s) on the wrist and/or forearm
5. Tattoos, large moles, or scars on the wrist at the wrist device location
6. Skin conditions on either wrist that would preclude subject from wearing a wristband on either wrist
7. Known allergy or sensitivity to medical adhesives, isopropyl alcohol, wristbands, or ECG patch
8. Medical history or physical assessment finding that makes the subject inappropriate for participation according to investigator(s)
9. Participation in a previous study that used a wrist-worn sensor device with a simultaneous ECG reference patch
10. Implantable cardiac devices such as a Pacemaker or Implantable Cardioverter Defibrillator
11. Clinically significant hand tremors, as judged by the investigator
12. Acute illness including COVID and other respiratory illnesses
13. 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

Primary outcomes:
measure: SENSITIVITY OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF]
timeFrame: 13 DAYS
measure: SPECIFICITY OF LACK OF IRREGULAR RHYTHM NOTIFICATIONS FEATURE [IRNF]
timeFrame: 13 DAYS
measure: WEEKLY ATRIAL FIBRILLATION BURDEN FEATURE ESTIMATE [AFBF]
timeFrame: 13 DAYS
Secondary outcomes:
measure: POSITIVE PREDICTIVE VALUE OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF]
timeFrame: 13 DAYS
measure: TACHOGRAM ALERT SENSITIVITY [IRNF]
timeFrame: 13 DAYS
measure: TACHOGRAM ALERT SPECIFICITY [IRNF]
timeFrame: 13 DAYS
measure: Tachogram Alert False Positive Rate [IRNF]
timeFrame: 13 DAYS
measure: Tachogram Alert Positive Predictive Value [IRNF]
timeFrame: 13 DAYS
measure: Tachogram Alert Negative Predictive Value [IRNF]
timeFrame: 13 DAYS
measure: TACHOGRAM SENSITIVITY [IRNF]
timeFrame: 13 DAYS
measure: TACHOGRAM SPECIFICITY [IRNF]
timeFrame: 13 DAYS
measure: TACHOGRAM FALSE POSITIVE RATE [IRNF]
timeFrame: 13 DAYS
measure: TACHOGRAM POSITIVE PREDICTIVE VALUE [IRNF]
timeFrame: 13 DAYS
measure: TACHOGRAM NEGATIVE PREDICTIVE VALUE [IRNF]
timeFrame: 13 DAYS
measure: TACHOGRAM SENSITIVITY [AFBF]
timeFrame: 13 days
measure: TACHOGRAM SPECIFICITY [AFBF]
timeFrame: 13 days
measure: TACHOGRAM POSITIVE PREDICTIVE VALUE [AFBF]
timeFrame: 13 days
measure: TACHOGRAM NEGATIVE PREDICTIVE VALUE [AFBF]
timeFrame: 13 days
measure: DAY-SPECIFIC AF BURDEN ESTIMATE [AFBF]
timeFrame: 13 DAYS
measure: FOUR-HOUR SEGMENT SPECIFIC AF BURDEN ESTIMATE [AFBF]
timeFrame: 13 DAYS
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Avon
country: United States
facility: American Health Network of Indiana Llc
state: Indiana
city: Wichita
country: United States
facility: Heartland Cardiology Webb
state: Kansas
city: Saint Paul
country: United States
facility: Healtheast
state: Minnesota
Study officials:
affiliation: Apple Inc.
name: David Tsay, MD, PhD
role: STUDY_DIRECTOR
References: