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Atrial FibrillationNCT04247581

ECG App Algorithms Clinical Validation Study

A study testing 1-lead ECG 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 performance of ECG classification algorithms and their ability to classify heart rhythms into multiple categories of rhythms and heart rates 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
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
546 participants
Where
4 sitesUnited States
Study dates
7 Jan 2020to 20 Mar 2020
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

  • Subjects must meet all the following inclusion criteria to be enrolled:
  • Able to read, understand, and provide written informed consent
  • Willing and able to participate in the study procedures as described in the consent form
  • Individuals who are 22 years of age and older at time of screening
  • Able to communicate effectively with and follow instructions from the study staff
  • Have a wrist circumference between 130 mm and 245 mm (Measured at "band center" on the preferred wrist).
  • Subjects enrolled into Cohort 1 must have no known medical history of AF and in normal sinus rhythm at the time of screening.
  • Subjects enrolled into Cohort 2 must have a known diagnosis of persistent or permanent AF and be in AF at the time of screening.

Who cannot join

  • Subjects must meet none of the following criteria to be enrolled:
  • Physical disability that precludes safe and adequate testing
  • Physical or medical impairments that preclude exercise testing such as musculoskeletal back pain, arthritis, leg claudication, etc.
  • Mental impairment as determined by the Investigator
  • Pregnant women at the time of the screening visit.
  • Subjects with any Medical History, Physical exam, vital sign or any other study procedure finding/assessment that in the opinion of the investigator could compromise subject safety during study participation or interfere with the study integrity and/or the accurate assessment of the study objectives. This includes patients with known untreated medical conditions that are considered clinically significant by the Investigator, such as but not limited to significant anemia, important electrolyte imbalance and untreated or uncontrolled thyroid disease. Physical exam limitations include but not limited to open wound(s) on the wrist and forearm where the subject will be wearing the watch.
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  • Any history of wrist surgery with scarring in the area of the sensor location on the wrist where the subject will be wearing the watch
  • Vital signs measurement, medical history, or physical exam finding that makes the subject inappropriate for participation according to the Investigator.
  • Tattoos or moles in the area of the sensor location on the wrist where the subject will be wearing the watch.
  • Skin conditions on either wrist that would preclude subject from wearing watch on either wrist. Severe symptomatic (or active) overly dry/injured skin, skin disorders, or allergic skin reactions such as eczema, rosacea, impetigo, dermatomyositis or allergic contact dermatitis on wrist and locations where the electrodes will be placed (e.g. chest, forearms, stomach), as determined by the investigator.
  • Known allergy or significant sensitivity to medical adhesives, isopropyl alcohol, or ECG patch
  • Known allergy or sensitivity to fluorocarbon-based synthetic rubber, such as fluoroelastomer bands primarily used in the wrist worn fitness devices.
  • Clinically significant hand tremors as judged by the Investigator.
  • Participation in a previous study that involved a wrist-worn ECG device.
  • Subjects with implanted cardiac devices such as a Pacemaker or an automated Implantable Cardioverter - Defibrillator

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

  • Hope Research Institute

    Phoenix, Arizona, 85018

  • Heartland Cardiology

    Wichita, Kansas, 67226

Other trials in United States

About this study

The purpose of the study is to evaluate the performance of ECG classification algorithms and their ability to classify heart rhythms into multiple categories of rhythms and heart rates

Being tested
1-lead ECG
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.

  • 1-lead ECGDevice

    Also called 12- lead ECG, Exercise

    1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.

    Intervention Other: Exercise - All participants will undergo three trials of exercise.

    Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions.

Study groups in NCT04247581
Study groupRoleWhat they receive
Cohort 1OtherThis will include subjects with no known history of AF and are in normal sinus rhythm at time of screening
Receives: Device: 1-lead ECG
Cohort 2OtherThis will include subjects with known persistent or permanent AF who are in AF at the time of screening
Receives: Device: 1-lead ECG

What is being measured

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

  1. Percentage of Trials With Correct Classification of Normal Sinus Rhythm on Simultaneous 12-lead ECG as "Sinus Rhythm" or "High Heart Rate" on a Readable and Classifiable ECG App Strip.

    Specificity of sinus rhythm classification

    Measured: 1 Day

  2. Percentage of Trials With Correct Classification of AF on Simultaneous 12-lead ECG as "AF" on a Readable and Classifiable ECG App Strip.

    Sensitivity of sinus rhythm classification

    Measured: 1 Day

Secondary outcomes (6)

  1. Percentage of Trials With Correct Classification of Normal Sinus Rhythm at Normal Heart Rates as "Sinus Rhythm" on a Readable and Classifiable ECG App Strip

    Measured: 1 Day

  2. Percentage of Trials With Correct Classification of AF at Normal Heart Rates as "AF" on a Readable and Classifiable ECG App Strip

    Measured: 1 Day

  3. Percentage of Trials With Correct Classification of Sinus Tachycardia at High Heart Rates as "High Heart Rate" on a Readable and Classifiable ECG App Strip

    Measured: 1 Day

  4. Percentage of Trials With Correct Classification of AF at High Heart Rates as "AF (High Heart Rate)" on a Readable and Classifiable ECG App Strip

    Measured: 1 Day

  5. Percentage of Trials With Equivalence of the ECG App Waveform to Lead I From a 12-lead ECG as Measured by Acceptable Morphology of PQRST Complexes

    A "pass" rating is given when the waveforms of the ECG tracings generated by the algorithm and the Lead 1 of the 12-Lead ECG appear to overlay to the unaided eye. The morphology of the waveforms will be considered equivalent if at least 80% of the paired waveforms for the first 6 PQRST complexes are given a "pass" rating.

    Measured: 1 Day

  6. Percentage of Trials With Equivalence of the ECG App Waveform to Lead I From a 12-lead ECG as Measured by R-Wave Amplitude Agreement

    A "pass" rating is given when the difference of the R-wave amplitudes (typically the highest peak of one cardiac rhythm cycle) between the ECG tracings generated by the algorithm and the Lead 1 of the 12-Lead ECG is <= 2mm. The R-wave amplitude agreement will be considered equivalent if at least 80% of the largest R-wave amplitudes of the paired waveforms are given a "pass" rating.

    Measured: 1 Day

Timeline

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

  1. First posted30 Jan 2020
  2. Study start7 Jan 2020
  3. Primary completion20 Mar 2020
  4. Study completion20 Mar 2020

Resources

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
546 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04247581
Sponsor's protocol ID
013
Status last verified
Sep 2021
First submitted
28 Jan 2020
Last updated
28 Sep 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing 1-lead ECG 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 8 inclusion and 15 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 28 Sep 2021. 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 28 Sep 2021). 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?

Percentage of Trials With Correct Classification of Normal Sinus Rhythm on Simultaneous 12-lead ECG as "Sinus Rhythm" or "High Heart Rate" on a Readable and Classifiable ECG App Strip. (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?

On the ClinicalTrials.gov record for NCT04247581.

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 28 Sep 2021.

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ECG App Algorithms Clinical Validation Study | AzTrials