Atrial Fibrillation Algorithms Clinical Validation Study

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 Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: ELECTROCARDIOGRAM (ECG) PATCH WEAR

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 Type: Interventional
• Enrollment (Actual): 573
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Clinical Research of South Florida
  • Indiana
    • Avon, Indiana, United States, 46123
      • American Health Network of Indiana LLC
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Heartland Cardiology Webb
  • Minnesota
    • Saint Paul, Minnesota, United States, 55012
      • Healtheast

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: COHORT 1; This will include subjects with no known history of AF	Device: ELECTROCARDIOGRAM (ECG) PATCH WEAR; ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION; Other Names: CARDEASOLO
OTHER: COHORT 2; 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)	Device: ELECTROCARDIOGRAM (ECG) PATCH WEAR; ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION; Other Names: CARDEASOLO
OTHER: COHORT 3; This will include subjects with known history of paroxysmal, persistent, or chronic AF	Device: ELECTROCARDIOGRAM (ECG) PATCH WEAR; ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION; Other Names: CARDEASOLO
OTHER: COHORT 4; Will include subjects with permanent AF	Device: ELECTROCARDIOGRAM (ECG) PATCH WEAR; ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION; Other Names: CARDEASOLO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SENSITIVITY OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF]	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.	13 DAYS
SPECIFICITY OF LACK OF IRREGULAR RHYTHM NOTIFICATIONS FEATURE [IRNF]	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.	13 DAYS
WEEKLY ATRIAL FIBRILLATION BURDEN FEATURE ESTIMATE [AFBF]	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.	13 DAYS

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Apple Inc.
• Collaborators: IQVIA Pty Ltd
• Investigators: Study Director: David Tsay, MD, PhD, Apple Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 16, 2020
• Primary Completion (ACTUAL): April 19, 2021
• Study Completion (ACTUAL): December 17, 2021

Study Registration Dates

• First Submitted: December 4, 2020
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (ACTUAL): January 7, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: CARDIOVASCULAR DISEASES; HEART DISEASES; ARRHYTHMIA; CARDIAC
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 099-25141

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes