ECG App Algorithms Clinical Validation 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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: 1-lead ECG

• Study Type: Interventional
• Enrollment (Actual): 546
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Hope Research Institute
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Clinical Research of South Florida
  • Indiana
    • Avon, Indiana, United States, 46123
      • American Health Network of Indiana LLC
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Heartland Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Cohort 1; This will include subjects with no known history of AF and are in normal sinus rhythm at time of screening	Device: 1-lead ECG; 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.; Other Names: Exercise; 12- lead ECG
OTHER: Cohort 2; This will include subjects with known persistent or permanent AF who are in AF at the time of screening	Device: 1-lead ECG; 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.; Other Names: Exercise; 12- lead ECG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 Day
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	1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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		1 Day
Percentage of Trials With Correct Classification of AF at Normal Heart Rates as "AF" on a Readable and Classifiable ECG App Strip		1 Day
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		1 Day
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		1 Day
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.	1 Day
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.	1 Day

Collaborators and Investigators

• Sponsor: Apple Inc.
• Collaborators: IQVIA Pty Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 7, 2020
• Primary Completion (ACTUAL): March 20, 2020
• Study Completion (ACTUAL): March 20, 2020

Study Registration Dates

• First Submitted: January 28, 2020
• First Submitted That Met QC Criteria: January 28, 2020
• First Posted (ACTUAL): January 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Arrhythmia; Cardiovascular diseases; Cardiac; Heart Diseases
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 013 (Nahrain Medical Research Collective (NMRC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No