Atrial FibrillationNCT03769207

Evaluation of the Use of Apple Watch Features for Identification of Cardiac Arrhythmias

A study testing Ambulatory ECG in people with Atrial Fibrillation and Arrhythmias, Cardiac, run by Apple Inc. at 1 site 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

This post-marketing study is conducted to characterize the ability of Apple Watch rhythm analysis software to identify Atrial Fibrillation (AF) and facilitate subsequent clinical evaluation among users who contact AppleCare. 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, Arrhythmias, Cardiac, Atrial Flutter
What is being tested?: Ambulatory ECG
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteUnited States
Study dates: 8 Dec 2018to 20 Aug 2019
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

Possession of the following at time of eligibility screening:
iPhone (5s or later) with iOS version 12.1.1 or later defined as iPhone model/iOS version used to complete screening eligibility.
Apple Watch (Series 1-4) with watchOS version 5.1.2 or later defined as Apple Watch model/watchOS paired with iPhone used to complete screening eligibility
At least one of the following by self-report before consent:
Irregular Rhythm Notification
ECG app classification of Atrial Fibrillation

Show all 12Show fewer

ECG app classification of Inconclusive defined as "Inconclusive," "Heart Rate Over 120," or "Heart Rate Under 50"
Age ≥ 22 years at time of eligibility screening
Current resident of the United States at time of eligibility screening, and will reside in the United States for the length of the study
Proficient in written and spoken English
Valid phone number associated with iPhone, ascertained from self-report
Valid email address, ascertained from self-report

Who cannot join

Shared iCloud account
Shared AppleWatch

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University
Stanford, California, 94304

Other trials in United States

About this study

Conditions: Atrial Fibrillation, Arrhythmias, Cardiac, Atrial Flutter
Being tested: Ambulatory ECG
Medical subject headings: Atrial Fibrillation, Arrhythmias, Cardiac, Atrial Flutter

What participants receive

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

Ambulatory ECGDevice
Eligible participants are asked to wear the ambulatory ECG monitor

Study groups in NCT03769207
Study group	Role	What they receive
Ambulatory ECG	Other	Not described Receives: Device: Ambulatory ECG

What is being measured

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

Atrial Fibrillation or Atrial Flutter (AF) of at Least 30 Seconds Duration
Detected on ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification
Measured: During ambulatory ECG Monitoring (up to 8 days)

Secondary outcomes (2)

Arrhythmias Other Than AF
Detected on an ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification
Measured: During ambulatory ECG Monitoring (up to 8 days)
Self-reported Contact With Healthcare Provider
Measured: Between 15 to 90 days following enrollment

Timeline

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

8 Dec 201820 Aug 2019

First posted7 Dec 2018
Study start8 Dec 2018
Primary completion5 Jul 2019
Study completion20 Aug 2019

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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03769207
Sponsor's protocol ID: 1.2
Other IDs: 48787
Status last verified: Sep 2020
First submitted: 6 Dec 2018
Last updated: 20 Oct 2020
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

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Use of Apple Watch Features for Identification of Cardiac Arrhythmias
ClinicalTrials.gov ID: NCT03769207
Acronym / sponsor ID: 1.2
Conditions: Atrial Fibrillation, Arrhythmias, Cardiac, Atrial Flutter
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Apple Inc.Industry (pharma, biotech, devices)
Study start: 8 Dec 2018 (actual)
Primary completion: 5 Jul 2019 (actual)
Study completion: 20 Aug 2019 (actual)
First posted: 7 Dec 2018 (actual)
Results: Posted 20 Oct 2020

Clinical summary

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

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Ambulatory ECG	Other	Device: Ambulatory ECG

Who may qualify

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

Key inclusion criteria (12 listed)

Possession of the following at time of eligibility screening:
At least one of the following by self-report before consent:
Age ≥ 22 years at time of eligibility screening
Current resident of the United States at time of eligibility screening, and will reside in the United States for the length of the study
Proficient in written and spoken English

Key exclusion criteria (2 listed)

Shared iCloud account
Shared AppleWatch

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
Ambulatory ECGEligible participants are asked to wear the ambulatory ECG monitor	Device	Ambulatory ECG

Primary outcome

Atrial Fibrillation or Atrial Flutter (AF) of at Least 30 Seconds Duration
Time frame: During ambulatory ECG Monitoring (up to 8 days)
Detected on ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification

2 secondary outcomes

Arrhythmias Other Than AF
Time frame: During ambulatory ECG Monitoring (up to 8 days)
Self-reported Contact With Healthcare Provider
Time frame: Between 15 to 90 days following enrollment

Results and safety

Results posted to the registry on 20 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ambulatory ECG	17	6

Primary outcome: Atrial Fibrillation or Atrial Flutter (AF) of at Least 30 Seconds Duration

Time frame: During ambulatory ECG Monitoring (up to 8 days). Number (95% Confidence Interval). Unit: Proportion of participants

Measure	Ambulatory ECG n = 9
Value	0.11 (0.003 to 0.48)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 9 months (participants may have reported adverse events at any time from enrollment to close of study). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ambulatory ECG	0 of 17 (0%)	4 of 17 (23.5%)	0 of 17

Limitations and caveats (from the sponsor): The small number of enrolled participants prevents us from drawing meaningful conclusions from this study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

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.

Marco V Perez, MD principal investigator

Stanford University

Minang (Mintu) Turakhia, MD, MAS principal investigator

Stanford University

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

Questions about this trial

What is this clinical trial studying?

A study testing Ambulatory ECG in people with Atrial Fibrillation and Arrhythmias, Cardiac, run by Apple Inc. at 1 site 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 12 inclusion and 2 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 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 20 Oct 2020). 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?

Atrial Fibrillation or Atrial Flutter (AF) of at Least 30 Seconds Duration (time frame: During ambulatory ECG Monitoring (up to 8 days)). 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 NCT03769207.

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 20 Oct 2020.