ECG App Algorithms Clinical Validation Study

NCT04247581 | Completed Results FDA Device

• 1 other identifier: 013
• Study Type: interventional
• Target: 546
• Locations: 1 country
• Sites: 4

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

Conditions

Atrial Fibrillation

Keywords

Cardiovascular diseases; Heart Diseases; Arrhythmia; Cardiac

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

  1 Day

Study Arms (2)

Cohort 1

OTHER

This will include subjects with no known history of AF and are in normal sinus rhythm at time of screening

Device: 1-lead ECG

Cohort 2

OTHER

This will include subjects with known persistent or permanent AF who are in AF at the time of screening

Device: 1-lead ECG

Interventions

1-lead ECG DEVICE

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.

Also known as: 12- lead ECG, Exercise

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Apple Inc.: lead
• Iqvia Pty Ltd: collaborator

Study Sites (4)

Hope Research Institute

Phoenix, Arizona, 85018, United States

Location

Clinical Research of South Florida

Coral Gables, Florida, 33134, United States

Location

American Health Network of Indiana LLC

Avon, Indiana, 46123, United States

Location

Heartland Cardiology

Wichita, Kansas, 67226, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Cardiovascular Diseases; Heart Diseases; Arrhythmias, Cardiac

Interventions

Electrocardiography; Exercise Therapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Results Point of Contact

• Title: Health Tech Clinical Operations
• Organization: Apple

htclinicalquestions@apple.com

866-905-5303

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: January 30, 2020
• Study Start: January 7, 2020
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: September 28, 2021
• Results First Posted: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)