Clinical trial NCT04247581: ECG App Algorithms Clinical Validation Study
Official title: ECG App Algorithms Clinical Validation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Cardiovascular diseases
Heart Diseases
Arrhythmia
Cardiac
Lead sponsor: Apple Inc.
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2020-01-30
Enrollment: 546
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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


Eligibility criteria: Inclusion Criteria:

* Subjects must meet all the following inclusion criteria to be enrolled:

  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. Individuals who are 22 years of age and older at time of screening
  4. Able to communicate effectively with and follow instructions from the study staff
  5. Have a wrist circumference between 130 mm and 245 mm (Measured at "band center" on the preferred wrist).
  6. Subjects enrolled into Cohort 1 must have no known medical history of AF and in normal sinus rhythm at the time of screening.
  7. Subjects enrolled into Cohort 2 must have a known diagnosis of persistent or permanent AF and be in AF at the time of screening.

Exclusion Criteria:

* Subjects must meet none of the following criteria to be enrolled:

  1. Physical disability that precludes safe and adequate testing
  2. Physical or medical impairments that preclude exercise testing such as musculoskeletal back pain, arthritis, leg claudication, etc.
  3. Mental impairment as determined by the Investigator
  4. Pregnant women at the time of the screening visit.
  5. 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.
  6. 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
  7. Vital signs measurement, medical history, or physical exam finding that makes the subject inappropriate for participation according to the Investigator.
  8. Tattoos or moles in the area of the sensor location on the wrist where the subject will be wearing the watch.
  9. 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.
  10. Known allergy or significant sensitivity to medical adhesives, isopropyl alcohol, or ECG patch
  11. Known allergy or sensitivity to fluorocarbon-based synthetic rubber, such as fluoroelastomer bands primarily used in the wrist worn fitness devices.
  12. Clinically significant hand tremors as judged by the Investigator.
  13. Participation in a previous study that involved a wrist-worn ECG device.
  14. Subjects with implanted cardiac devices such as a Pacemaker or an automated Implantable Cardioverter - Defibrillator

Primary outcomes:
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.
timeFrame: 1 Day
measure: Percentage of Trials With Correct Classification of AF on Simultaneous 12-lead ECG as "AF" on a Readable and Classifiable ECG App Strip.
timeFrame: 1 Day
Secondary outcomes:
measure: 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
timeFrame: 1 Day
measure: Percentage of Trials With Correct Classification of AF at Normal Heart Rates as "AF" on a Readable and Classifiable ECG App Strip
timeFrame: 1 Day
measure: 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
timeFrame: 1 Day
measure: 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
timeFrame: 1 Day
measure: 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
timeFrame: 1 Day
measure: 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
timeFrame: 1 Day
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Avon
country: United States
facility: American Health Network of Indiana LLC
state: Indiana
city: Wichita
country: United States
facility: Heartland Cardiology
state: Kansas
Study officials:
References: