Atrial Fibrillation Algorithms Clinical Validation Study

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: ELECTROCARDIOGRAM (ECG) PATCH WEAR

• Registration Number: NCT04699812
• Lead Sponsor: Apple Inc.

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.

Study Timeline

• Study Start: 2020-11-16
• Study First Submitted: 2020-12-04
• Study First Submitted QC: 2021-01-05
• Study First Posted: 2021-01-07
• Primary Completion: 2021-04-19
• Study Completion: 2021-12-17
• Results First Submitted: 2022-07-01
• Status Verified: 2022-08
• Results First Submitted QC: 2022-08-01
• Last Update Submitted: 2022-08-01
• Results First Posted: 2022-08-24
• Last Update Posted: 2022-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 573

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COHORT 3	ELECTROCARDIOGRAM (ECG) PATCH WEAR	This will include subjects with known history of paroxysmal, persistent, or chronic AF
COHORT 4	ELECTROCARDIOGRAM (ECG) PATCH WEAR	Will include subjects with permanent AF
COHORT 1	ELECTROCARDIOGRAM (ECG) PATCH WEAR	This will include subjects with no known history of AF
COHORT 2	ELECTROCARDIOGRAM (ECG) PATCH WEAR	This will include subjects with no known history of aF, but with history of frequent premature atrial contractions (PACs), frequent premature ventricular contractions (PVCs), supraventricular tachycardia (SVT), or non-sustained ventricular tachycardia (NSVT)

Primary Outcome Measures

Name	Time	Method
WEEKLY ATRIAL FIBRILLATION BURDEN FEATURE ESTIMATE [AFBF]	13 DAYS	Weekly AF burden estimate defined as the percentage of time a subject is in Atrial Fibrillation during wrist device wear over the prior 7 consecutive days. The weekly AF burden was estimated by both the reference device and the algorithm and reported using the Bland-Altman limits of Agreement.
SENSITIVITY OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF]	13 DAYS	Sensitivity of the irregular rhythm notification for the identification of persons with AF by 13-day ambulatory ECG, with AF defined as at least 30 seconds of AF by ambulatory ECG. Sensitivity is defined as the percentage of subjects exhibiting AF on the ambulatory ECG who also received an irregular rhythm notification concordant with at least one episode of AF.
SPECIFICITY OF LACK OF IRREGULAR RHYTHM NOTIFICATIONS FEATURE [IRNF]	13 DAYS	Specificity of the lack of irregular rhythm notification for the identification of persons without AF by 13-day ambulatory ECG, with AF defined as at least 30 seconds of AF by ambulatory ECG. Specificity is defined as the percentage of subjects not exhibiting AF on the ambulatory ECG who also did not receive any irregular rhythm notifications.

Secondary Outcome Measures

Name	Time	Method
TACHOGRAM FALSE POSITIVE RATE [IRNF]	13 DAYS	Tachogram-level false positive rate performance for all generated tachograms.
TACHOGRAM SPECIFICITY [IRNF]	13 DAYS	Tachogram-level specificity performance for all generated tachograms.
TACHOGRAM POSITIVE PREDICTIVE VALUE [IRNF]	13 DAYS	Tachogram-level positive predictive value performance for all generated tachograms.
TACHOGRAM SENSITIVITY [IRNF]	13 DAYS	Tachogram-level sensitivity performance for all generated tachograms.
FOUR-HOUR SEGMENT SPECIFIC AF BURDEN ESTIMATE [AFBF]	13 DAYS	Four-hour segment-specific AF burden estimate defined as the percentage of time a subject is in Atrial Fibrillation during a specific four-hour segment of a day
TACHOGRAM NEGATIVE PREDICTIVE VALUE [IRNF]	13 DAYS	Tachogram-level negative predictive value performance for all generated tachograms.
TACHOGRAM POSITIVE PREDICTIVE VALUE [AFBF]	13 days	Positive Predictive Value of tachograms for the identification of AF by ambulatory ECG.
TACHOGRAM NEGATIVE PREDICTIVE VALUE [AFBF]	13 days	Negative Predictive Value of tachograms for the identification of AF by ambulatory ECG.
DAY-SPECIFIC AF BURDEN ESTIMATE [AFBF]	13 DAYS	Day-specific AF burden estimate defined as the percentage of time a subject is in Atrial Fibrillation during a specific day of the week.
Tachogram Alert False Positive Rate [IRNF]	13 DAYS	Tachogram-level False Positive rate performance for tachograms comprising alerts.
Tachogram Alert Negative Predictive Value [IRNF]	13 DAYS	Tachogram-level Negative Predictive value performance for tachograms comprising alerts.
TACHOGRAM SENSITIVITY [AFBF]	13 days	Sensitivity of tachograms for the identification of AF by ambulatory ECG.
TACHOGRAM SPECIFICITY [AFBF]	13 days	Specificity of tachograms for the identification of AF by ambulatory ECG.
POSITIVE PREDICTIVE VALUE OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF]	13 DAYS	Notification-level positive predictive value (PPV) with AF by ambulatory ECG at the time of any tachogram comprising the notification.
TACHOGRAM ALERT SENSITIVITY [IRNF]	13 DAYS	Tachogram-level sensitivity performance for tachograms comprising alerts.
TACHOGRAM ALERT SPECIFICITY [IRNF]	13 DAYS	Tachogram-level specificity performance for tachograms comprising alerts.
Tachogram Alert Positive Predictive Value [IRNF]	13 DAYS	Tachogram-level Positive Predictive value performance for tachograms comprising alerts.

Trial Locations

Locations (4)

Heartland Cardiology Webb; 🇺🇸 Wichita, Kansas, United States

Clinical Research of South Florida; 🇺🇸 Coral Gables, Florida, United States

Healtheast; 🇺🇸 Saint Paul, Minnesota, United States

American Health Network of Indiana Llc; 🇺🇸 Avon, Indiana, United States