Atrial FibrillationNCT04699812

Atrial Fibrillation Algorithms Clinical Validation Study

A study testing ELECTROCARDIOGRAM (ECG) PATCH WEAR in people with Atrial Fibrillation, run by Apple Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 22 years and olderHealthy volunteers can take part
Conditions the study is for: Atrial Fibrillation
What is being tested?: ELECTROCARDIOGRAM (ECG) PATCH WEAR
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 573 participants
Where: 4 sitesUnited States
Study dates: 16 Nov 2020to 17 Dec 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Show all 14Show fewer

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.

Who cannot join

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

Show all 13Show fewer

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

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

Other trials in United States

About this 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.

Read the 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
Being tested: ELECTROCARDIOGRAM (ECG) PATCH WEAR
Keywords: CARDIOVASCULAR DISEASES, HEART DISEASES, ARRHYTHMIA, CARDIAC
Medical subject headings: Atrial Fibrillation, Cardiovascular Diseases, Heart Diseases, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ELECTROCARDIOGRAM (ECG) PATCH WEARDevice
Also called CARDEASOLO
ALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION

Study groups in NCT04699812
Study group	Role	What they receive
COHORT 1	Other	This will include subjects with no known history of AF Receives: 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) Receives: Device: ELECTROCARDIOGRAM (ECG) PATCH WEAR
COHORT 3	Other	This will include subjects with known history of paroxysmal, persistent, or chronic AF Receives: Device: ELECTROCARDIOGRAM (ECG) PATCH WEAR
COHORT 4	Other	Will include subjects with permanent AF Receives: Device: ELECTROCARDIOGRAM (ECG) PATCH WEAR

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 13 DAYS

Secondary outcomes (17)

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.
Measured: 13 DAYS
TACHOGRAM ALERT SENSITIVITY [IRNF]
Tachogram-level sensitivity performance for tachograms comprising alerts.
Measured: 13 DAYS
TACHOGRAM ALERT SPECIFICITY [IRNF]
Tachogram-level specificity performance for tachograms comprising alerts.
Measured: 13 DAYS
Tachogram Alert False Positive Rate [IRNF]
Tachogram-level False Positive rate performance for tachograms comprising alerts.
Measured: 13 DAYS
Tachogram Alert Positive Predictive Value [IRNF]
Tachogram-level Positive Predictive value performance for tachograms comprising alerts.
Measured: 13 DAYS
Tachogram Alert Negative Predictive Value [IRNF]
Tachogram-level Negative Predictive value performance for tachograms comprising alerts.
Measured: 13 DAYS
TACHOGRAM SENSITIVITY [IRNF]
Tachogram-level sensitivity performance for all generated tachograms.
Measured: 13 DAYS
TACHOGRAM SPECIFICITY [IRNF]
Tachogram-level specificity performance for all generated tachograms.
Measured: 13 DAYS
TACHOGRAM FALSE POSITIVE RATE [IRNF]
Tachogram-level false positive rate performance for all generated tachograms.
Measured: 13 DAYS
TACHOGRAM POSITIVE PREDICTIVE VALUE [IRNF]
Tachogram-level positive predictive value performance for all generated tachograms.
Measured: 13 DAYS
TACHOGRAM NEGATIVE PREDICTIVE VALUE [IRNF]
Tachogram-level negative predictive value performance for all generated tachograms.
Measured: 13 DAYS
TACHOGRAM SENSITIVITY [AFBF]
Sensitivity of tachograms for the identification of AF by ambulatory ECG.
Measured: 13 days
TACHOGRAM SPECIFICITY [AFBF]
Specificity of tachograms for the identification of AF by ambulatory ECG.
Measured: 13 days
TACHOGRAM POSITIVE PREDICTIVE VALUE [AFBF]
Positive Predictive Value of tachograms for the identification of AF by ambulatory ECG.
Measured: 13 days
TACHOGRAM NEGATIVE PREDICTIVE VALUE [AFBF]
Negative Predictive Value of tachograms for the identification of AF by ambulatory ECG.
Measured: 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.
Measured: 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
Measured: 13 DAYS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Nov 202017 Dec 2021

First posted7 Jan 2021
Study start16 Nov 2020
Primary completion19 Apr 2021
Study completion17 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 573 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04699812
Sponsor's protocol ID: 099-25141
Status last verified: Aug 2022
First submitted: 4 Dec 2020
Last updated: 24 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Atrial Fibrillation Algorithms Clinical Validation Study
ClinicalTrials.gov ID: NCT04699812
Acronym / sponsor ID: 099-25141
Conditions: Atrial Fibrillation
Keywords: CARDIOVASCULAR DISEASES, HEART DISEASES, ARRHYTHMIA, CARDIAC
Study type: Interventional
Recruitment status: Completed
Enrolment: 573 participants (actual)
Lead sponsor: Apple Inc.Industry (pharma, biotech, devices)
Collaborators: IQVIA Pty Ltd
Study start: 16 Nov 2020 (actual)
Primary completion: 19 Apr 2021 (actual)
Study completion: 17 Dec 2021 (actual)
First posted: 7 Jan 2021 (actual)
Results: Posted 24 Aug 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
COHORT 1	Other	Device: ELECTROCARDIOGRAM (ECG) PATCH WEARThis will include subjects with no known history of AF
COHORT 2	Other	Device: ELECTROCARDIOGRAM (ECG) PATCH WEARThis 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)
COHORT 3	Other	Device: ELECTROCARDIOGRAM (ECG) PATCH WEARThis will include subjects with known history of paroxysmal, persistent, or chronic AF
COHORT 4	Other	Device: ELECTROCARDIOGRAM (ECG) PATCH WEARWill include subjects with permanent AF

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

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

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ELECTROCARDIOGRAM (ECG) PATCH WEARAlso: CARDEASOLOALL PARTICIPANTS WILL WEAR AN ECG PATCH ON THEIR UPPER LEFT CHEST THROUGHOUT THE STUDY PARTICIPATION	Device	COHORT 1, COHORT 2, COHORT 3, COHORT 4

Primary outcome

SENSITIVITY OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF]
Time frame: 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]
Time frame: 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.
WEEKLY ATRIAL FIBRILLATION BURDEN FEATURE ESTIMATE [AFBF]
Time frame: 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.

17 secondary outcomes

POSITIVE PREDICTIVE VALUE OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF]
Time frame: 13 DAYS
TACHOGRAM ALERT SENSITIVITY [IRNF]
Time frame: 13 DAYS
TACHOGRAM ALERT SPECIFICITY [IRNF]
Time frame: 13 DAYS
Tachogram Alert False Positive Rate [IRNF]
Time frame: 13 DAYS
Tachogram Alert Positive Predictive Value [IRNF]
Time frame: 13 DAYS
Tachogram Alert Negative Predictive Value [IRNF]
Time frame: 13 DAYS
TACHOGRAM SENSITIVITY [IRNF]
Time frame: 13 DAYS
TACHOGRAM SPECIFICITY [IRNF]
Time frame: 13 DAYS
TACHOGRAM FALSE POSITIVE RATE [IRNF]
Time frame: 13 DAYS
TACHOGRAM POSITIVE PREDICTIVE VALUE [IRNF]
Time frame: 13 DAYS
TACHOGRAM NEGATIVE PREDICTIVE VALUE [IRNF]
Time frame: 13 DAYS
TACHOGRAM SENSITIVITY [AFBF]
Time frame: 13 days
TACHOGRAM SPECIFICITY [AFBF]
Time frame: 13 days
TACHOGRAM POSITIVE PREDICTIVE VALUE [AFBF]
Time frame: 13 days
TACHOGRAM NEGATIVE PREDICTIVE VALUE [AFBF]
Time frame: 13 days
DAY-SPECIFIC AF BURDEN ESTIMATE [AFBF]
Time frame: 13 DAYS
FOUR-HOUR SEGMENT SPECIFIC AF BURDEN ESTIMATE [AFBF]
Time frame: 13 DAYS

Results and safety

Results posted to the registry on 24 Aug 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
COHORT 1	78	70
COHORT 2	82	64
COHORT 3	366	304
COHORT 4	47	45

Primary outcome: SENSITIVITY OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF]

Time frame: 13 DAYS. Number. Unit: percentage of participants

Measure	COHORT 1 n = 1	COHORT 2 n = 0	COHORT 3 n = 103	COHORT 4 n = 36	Overall n = 140
Value	NA	–	NA	NA	88.6

Population analysed: Per the pre-specified analysis plan, subjects from only Cohorts 1, 3, and 4 were to be included in the analysis. The pre-specified analysis also required the results to be pooled across these 3 cohorts and were not to be reported separately by cohort.

Primary outcome: SPECIFICITY OF LACK OF IRREGULAR RHYTHM NOTIFICATIONS FEATURE [IRNF]

Time frame: 13 DAYS. Number. Unit: percentage of participants

Measure	COHORT 1 n = 66	COHORT 2 n = 0	COHORT 3 n = 219	COHORT 4 n = 7	Overall n = 292
Value	NA	–	NA	NA	99.3

Primary outcome: WEEKLY ATRIAL FIBRILLATION BURDEN FEATURE ESTIMATE [AFBF]

Time frame: 13 DAYS. Number. Unit: Bland-Altman Limits of Agreement

Measure	COHORT 3 n = 244	COHORT 4 n = 36	Overall n = 280
Lower Limit of Agreement (%)	NA	NA	-11.4
Upper Limit of Agreement (%)	NA	NA	12.8

Population analysed: Per the pre-specified analysis plan, subjects from only Cohorts 3 and 4 (i.e., those with a prior diagnosis of AF) were to be included in the analysis. The pre-specified analysis also required the results to be pooled across these 2 cohorts and were not to be reported separately by cohort.

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3.5 months. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
COHORT 1	0 of 78 (0%)	3 of 78 (3.8%)	0 of 78
COHORT 2	0 of 82 (0%)	11 of 82 (13.4%)	0 of 82
COHORT 3	7 of 366 (1.9%)	46 of 366 (12.6%)	0 of 366
COHORT 4	0 of 47 (0%)	3 of 47 (6.4%)	0 of 47

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Tsay, MD, PhD study director

Apple Inc.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ELECTROCARDIOGRAM (ECG) PATCH WEAR in people with Atrial Fibrillation, run by Apple Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SENSITIVITY OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF] (time frame: 13 DAYS). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04699812.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022; AzTrials last refreshed its copy on 27 Oct 2026.