Atrial Fibrillation Algorithms Clinical Validation Study

NCT04699812 | Completed Results FDA Device

• 1 other identifier: 099-25141
• Study Type: interventional
• Target: 573
• Locations: 1 country
• Sites: 4

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.

Conditions

Atrial Fibrillation

Keywords

CARDIOVASCULAR DISEASES; HEART DISEASES; ARRHYTHMIA; CARDIAC

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (17)

• POSITIVE PREDICTIVE VALUE OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF]

  13 DAYS

• TACHOGRAM ALERT SENSITIVITY [IRNF]

  13 DAYS

• TACHOGRAM ALERT SPECIFICITY [IRNF]

  13 DAYS

• Tachogram Alert False Positive Rate [IRNF]

  13 DAYS

• Tachogram Alert Positive Predictive Value [IRNF]

  13 DAYS

Study Arms (4)

COHORT 1

OTHER

This will include subjects with no known history of AF

Device: ELECTROCARDIOGRAM (ECG) PATCH WEAR

COHORT 2

OTHER

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

COHORT 3

OTHER

This will include subjects with known history of paroxysmal, persistent, or chronic AF

Device: ELECTROCARDIOGRAM (ECG) PATCH WEAR

COHORT 4

OTHER

Will include subjects with permanent AF

Device: ELECTROCARDIOGRAM (ECG) PATCH WEAR

Interventions

ELECTROCARDIOGRAM (ECG) PATCH WEAR DEVICE

ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION

Also known as: CARDEASOLO

COHORT 1; COHORT 2; COHORT 3; COHORT 4

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Apple Inc.: lead
• Iqvia Pty Ltd: collaborator

Study Sites (4)

Clinical Research of South Florida

Coral Gables, Florida, 33134, United States

Location

American Health Network of Indiana Llc

Avon, Indiana, 46123, United States

Location

Heartland Cardiology Webb

Wichita, Kansas, 67226, United States

Location

Healtheast

Saint Paul, Minnesota, 55012, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Cardiovascular Diseases; Heart Diseases; Arrhythmias, Cardiac

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Results Point of Contact

• Title: Clinical Health Product Clinician
• Organization: Apple Inc.

htclinicalquestions@apple.com

866-905-5303

Study Officials

• David Tsay, MD, PhD

  Apple Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: January 7, 2021
• Study Start: November 16, 2020
• Primary Completion: April 19, 2021
• Study Completion: December 17, 2021
• Last Updated: August 24, 2022
• Results First Posted: August 24, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)