Atrial Fibrillation Algorithms Clinical Validation Study

NCT ID: NCT04699812

Last Updated: 2022-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 573 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-16
• Study Completion Date: 2021-12-17

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

COHORT 1

This will include subjects with no known history of AF

Group Type: OTHER

ELECTROCARDIOGRAM (ECG) PATCH WEAR

Intervention Type: DEVICE

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

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)

Group Type: OTHER

ELECTROCARDIOGRAM (ECG) PATCH WEAR

Intervention Type: DEVICE

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

COHORT 3

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

Group Type: OTHER

ELECTROCARDIOGRAM (ECG) PATCH WEAR

Intervention Type: DEVICE

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

COHORT 4

Will include subjects with permanent AF

Group Type: OTHER

ELECTROCARDIOGRAM (ECG) PATCH WEAR

Intervention Type: DEVICE

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

Interventions

ELECTROCARDIOGRAM (ECG) PATCH WEAR

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

Intervention Type: DEVICE

Other Intervention Names

CARDEASOLO

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Iqvia Pty Ltd

INDUSTRY

Sponsor Role: collaborator

Apple Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Tsay, MD, PhD

Role: STUDY_DIRECTOR

Apple Inc.

Locations

Clinical Research of South Florida

Coral Gables, Florida, United States

American Health Network of Indiana Llc

Avon, Indiana, United States

Heartland Cardiology Webb

Wichita, Kansas, United States

Healtheast

Saint Paul, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

099-25141

Identifier Type: -

Identifier Source: org_study_id