ECG App Algorithms Clinical Validation Study

Atrial Fibrillation Clinical Trial

Official title:

ECG App Algorithms Clinical Validation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04247581
• Other study ID #: 013
• Status: Completed
• Phase: N/A
• Start date: January 7, 2020
• Est. completion date: March 20, 2020

Study information

• Verified date: September 2021
• Source: Apple Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 546
• Est. completion date: March 20, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
United States	American Health Network of Indiana LLC	Avon	Indiana
United States	Clinical Research of South Florida	Coral Gables	Florida
United States	Hope Research Institute	Phoenix	Arizona
United States	Heartland Cardiology	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Apple Inc.	Iqvia Pty Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Percentage of Trials With Correct Classification of AF at Normal Heart Rates as "AF" on a Readable and Classifiable ECG App Strip		1 Day
Secondary	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
Secondary	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
Secondary	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
Secondary	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