Atrial FibrillationNCT03492554
Electrocardiogram Clinical Validation Study
A study testing 1-Lead ECG and 12-Lead ECG in people with Atrial Fibrillation, run by Apple Inc. at 5 sites in United States.
Trial summary
The purpose of the study is to confirm the software's ability to create a Lead-1 electrocardiogram (ECG) that is clinically equivalent to a reference device. Also, to confirm a rhythm classification algorithm and its ability to detect and classify heart rhythms into two categories (Sinus Rhythm or Atrial Fibrillation)… 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?
- 1-Lead ECG and 12-Lead ECG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 602 participants
- Where
- 5 sitesUnited States
- Study dates
- 12 Mar 2018to 14 May 2018
- 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
- Individuals who are 22 years of age and older
- Able to read, understand, and provide written informed consent
- Willing and able to participate in the study procedures as described in the consent
- Have a wrist circumference that fits within the band
- Able to communicate effectively with and follow instructions from the study staff
- For subjects enrolled into the AF population, subjects must have a known diagnosis of AF and be in AF at the time of screening
Who cannot join
- Physical disability that precludes safe and adequate testing
- Mental impairment resulting in limited ability to cooperate
- Subjects with a pacemaker or implantable cardioverter-defibrillator (ICD)
- Acute myocardial infarction (MI) within 90 days of screening or other cardiovascular disease that, in the opinion of the Investigator, increases the risk to the subject or renders data uninterpretable
- Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis within 90 days of screening
- Stroke or transient ischemic attack within 90 days of screening
Show all 13Show fewer
- Subjects taking rhythm control drugs
- Symptomatic (or active) allergic skin reactions such as eczema, rosacea, impetigo, dermatomyositis or allergic contact dermatitis on both wrists or over electrode attachment sites
- Known sensitivity to medical adhesives, isopropyl alcohol, watch bands, or electrocardiogram (ECG) electrodes including known allergy or sensitivity to fluoroelastomer bands primarily used in wrist worn fitness devices
- A history of abnormal life-threatening rhythms as determined by the investigator
- Significant tremor that prevents subject from being able to hold still
- Pregnant women: Women who are pregnant at the time of study participation
- For subjects enrolled into the sinus rhythm population, they must not have any diagnosis of AF
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
QPS
Miami, Florida, 33143
BioClinicia- Orlando
Orlando, Florida, 32806
IQVIA
Overland Park, Kansas, 66211
Health East
Saint Paul, Minnesota, 55102
BioClinica- The Villages
The Villages, Florida, 32162
About this study
The purpose of the study is to confirm the software's ability to create a Lead-1 electrocardiogram (ECG) that is clinically equivalent to a reference device. Also, to confirm a rhythm classification algorithm and its ability to detect and classify heart rhythms into two categories (Sinus Rhythm or Atrial Fibrillation) using a single Lead ECG.
- Conditions
- Atrial Fibrillation
- Being tested
- 1-Lead ECG, 12-Lead ECG
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-Lead ECGOther
All participants will record three single-lead ECGs
12-Lead ECGDevice
All participants will simultaneously record three 12-lead ECGs
| Study group | Role | What they receive |
|---|---|---|
| Atrial fibrillation (AF) | Other | Patient with a known history of AF who are in AF at the time of study screening. Receives: Other: 1-Lead ECG; Device: 12-Lead ECG |
| Normal Sinus Rhythm (SR) | Other | Patient with no known diagnosis of AF or other arrhythmia Receives: Other: 1-Lead ECG; Device: 12-Lead ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Software's Rhythm Classification of SR in Agreement to a Physician's Interpretation of a Gold Standard 12-lead ECG
Specificity of rhythm classification
Measured: 1 Day
Number of Participants With Software's Rhythm Classification of AF in Agreement to a Physician's Interpretation of a Gold Standard 12-lead ECG
Sensitivity of rhythm classification
Measured: 1 Day
Secondary outcomes (3)
Number of Participants With Software's Ability to Produce a Clinically Equivalent Waveform in Agreement to a Gold Standard Lead 1 Reference
Number of ECGs that pass a visual overlay
Measured: 1 Day
Number of Participants With Software's Ability to Produce a Clinically Equivalent Waveform in Agreement to a Gold Standard Lead 1 Reference
Difference in R-wave amplitudes between the software and gold standard reference
Measured: 1 Day
Ease of Use
Average ease of use on a 1 (Unable to Use) to 5 (Easiest to Use) scale
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start12 Mar 2018
- Primary completion14 May 2018
- Study completion14 May 2018
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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apple Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492554
- Sponsor's protocol ID
- 099-11774
- Status last verified
- Nov 2020
- First submitted
- 27 Feb 2018
- Last updated
- 3 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrocardiogram Clinical Validation Study
- ClinicalTrials.gov ID
- NCT03492554
- Acronym / sponsor ID
- 099-11774
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 602 participants (actual)
- Lead sponsor
- Apple Inc.Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 14 May 2018 (actual)
- Study completion
- 14 May 2018 (actual)
- First posted
- 10 Apr 2018 (actual)
- Results
- Posted 24 Jul 2019
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 confirm the software's ability to create a Lead-1 electrocardiogram (ECG) that is clinically equivalent to a reference device. Also, to confirm a rhythm classification algorithm and its ability to detect and classify heart rhythms into two categories (Sinus Rhythm or Atrial Fibrillation) using a single Lead ECG.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atrial fibrillation (AF) | Other | Other: 1-Lead ECG, Device: 12-Lead ECGPatient with a known history of AF who are in AF at the time of study screening. |
| Normal Sinus Rhythm (SR) | Other | Other: 1-Lead ECG, Device: 12-Lead ECGPatient with no known diagnosis of AF or other arrhythmia |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals who are 22 years of age and older
- Able to read, understand, and provide written informed consent
- Willing and able to participate in the study procedures as described in the consent
- Have a wrist circumference that fits within the band
- Able to communicate effectively with and follow instructions from the study staff
Key exclusion criteria (13 listed)
- Physical disability that precludes safe and adequate testing
- Mental impairment resulting in limited ability to cooperate
- Subjects with a pacemaker or implantable cardioverter-defibrillator (ICD)
- Acute myocardial infarction (MI) within 90 days of screening or other cardiovascular disease that, in the opinion of the Investigator, increases the risk to the subject or renders data uninterpretable
- Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis within 90 days of screening
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 |
|---|---|---|
| 1-Lead ECGAll participants will record three single-lead ECGs | Other | Atrial fibrillation (AF), Normal Sinus Rhythm (SR) |
| 12-Lead ECGAll participants will simultaneously record three 12-lead ECGs | Device | Atrial fibrillation (AF), Normal Sinus Rhythm (SR) |
Primary outcome
Number of Participants With Software's Rhythm Classification of SR in Agreement to a Physician's Interpretation of a Gold Standard 12-lead ECG
Time frame: 1 Day
Specificity of rhythm classification
Number of Participants With Software's Rhythm Classification of AF in Agreement to a Physician's Interpretation of a Gold Standard 12-lead ECG
Time frame: 1 Day
Sensitivity of rhythm classification
3 secondary outcomes
Number of Participants With Software's Ability to Produce a Clinically Equivalent Waveform in Agreement to a Gold Standard Lead 1 Reference
Time frame: 1 Day
Number of Participants With Software's Ability to Produce a Clinically Equivalent Waveform in Agreement to a Gold Standard Lead 1 Reference
Time frame: 1 Day
Ease of Use
Time frame: 1 Day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1-Lead ECG and 12-Lead ECG in people with Atrial Fibrillation, run by Apple Inc. at 5 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 6 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 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 Jul 2019). 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?
Number of Participants With Software's Rhythm Classification of SR in Agreement to a Physician's Interpretation of a Gold Standard 12-lead ECG (time frame: 1 Day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2020; AzTrials last refreshed its copy on 27 Oct 2026.