A Study to Describe the Effectiveness of Arrhythmia Analysis Software for Screening of Sinus Rhythm, Atrial Fibrillation and Premature Beats in light-and Dark Skin Tone Patients

A Study to Describe the Effectiveness of Arrhythmia Analysis Software for Screening of Sinus Rhythm, Atrial Fibrillation and Premature Beats in Light skin-and Dark Skin Tone Patients

The purpose of this study is to describe the Huawei'ssoftware ("Arrhythmia Analysis Software") for the detection of atrial fibrillation, premature beats, and sinus rhythm using photoplethysmography (PPG). Data derived from a wearable device with a PPG sensor (watch or band) in patients with light skin or dark skin tones will be used as an index test. The Huawei software is intended as a pre-screening technology. It should identify candidates who may benefit from further evaluation. The software is not intended to be a diagnostic system.

The purpose of this descriptive study is to describe Huawei's arrhythmia analysis software on PPG data collected with a wearable device (smartwatch or smart band) in people of light and dark skin tones. The study will be conducted at a single research center in The Netherlands. The device under investigation is the Arrhythmia Analysis Software. The Arrhythmia Analysis Software processes a signal from the PPG sensor on a wearable device and displays results data on both the wearable device and mobile phone application.

Data generated from this study will be included in licensing/registration applications for the commercialization of the proposed arrhythmia analysis software. The protocol provides a detailed description of the study and data analysis plan and addresses regulatory requirements relating to ethics approvals, protocol deviations, and disclosure of data. The study will be conducted in compliance with the protocol and all applicable regulatory requirements.

This clinical investigation is a descriptive clinical study at a single research center in which the Huawei Arrhythmia Analysis Software is compared with 12-Lead ECG as the gold standard for arrhythmia detection. Analysis of the ECG output data will be performed by independent physicians who will be blinded to the Arrhythmia Analysis Software output. Also, the physicians deriving data from the Arrhythmia Analysis Software are blinded for analysis of the reference test, the 12-lead ECG. The adjudicated ECG output will then be used to validate the Arrhythmia Analysis Software algorithm.

The 12-lead ECG is the standard for early detection and monitoring of cardiac arrhythmias in Europe and has been used as a comparator.

Prior to enrolling the first patient, the sponsor provides training to the study site personnel to ensure that the study site personnel are fully aware of the research process and are skilled in operating the test instruments.

During the clinical investigation, the investigator must strictly follow the CIP and any related study procedures. The Principal Investigator should perform quality control and supervision to ensure that the investigators strictly follow the study plan. The above measures are implemented throughout the implementation phase of the study to reduce errors or operational errors.

Subjects were screened strictly according to the criteria for selection and exclusion of the CIP to reduce selective bias.

After enrollment, ECG/dynamic ECG results are independently interpreted by ECG physicians with more than 2 years of experience. These physicians were not involved in the ECG collection process and will not be informed of the subject's medical history and past ECG results to reduce the bias of subjective evaluation. Physicians performing the ECG interpretation were blinded to the measurements and outcomes of the Arrhythmia Analysis Software.

Physicians collecting the data from the ECG of the software are blinded for the interpretation of the 12-lead ECG 12-lead ECG was performed at the same time as the ECG from the Arrhythmia Analysis After ECG interpretation has been performed the ECG results were coupled to the Arrhythmia Analysis software output and transferred to the software validation team for analysis.

All the researchers involved in this clinical trial have the relevant working experience to ensure proficiency and standardization of the operation.

An electronic data capture (EDC) system was used to capture the data in this clinical investigation. The system allows for the use of (automated) edit checks and continuous, real-time remote monitoring of trial data by a data manager of the Sponsor. When data issues are detected, the data manager checks and confirms the data by questioning the Investigation Site to avoid recording errors.

Inclusion Criteria:

1. Age >18 of any sex;

2. Wrist circumference 140 mm - 210 mm;

3. Fitzpatrick skin type 1, 2, 5, or 6 (pre-screening);

4. Melanin Index (MI) <150 or >350 as measured on the inner arm;

5. One of the following conditions, based on past 3 months' history or screening electrocardiogram:

   1. Normal sinus rhythm;
   2. Persistent or permanent or onset atrial fibrillation;
   3. Frequent (>5 beats per minute) premature beats or ongoing premature beats;

6. Willing and able to provide voluntary, written informed consent

Exclusion Criteria:

1. Patients using pacemakers or implantable cardioverter defibrillators (ICDs);
2. Patients with atrioventricular block or bundle branch block;
3. Patients with sinus tachycardia, significant sinus bradycardia, significant sinus arrhythmia, sinus arrest or sick sinus syndrome;
4. Interpositional premature beats, dual-law premature beats, triple-law premature beats, border premature beats or escape beat heart rhythm patients;
5. Patients with atrial tachycardia, atrial flutter, ventricular tachycardia, ventricular flutter or ventricular fibrillation;
6. Patients with a resting heart rate less than 50 times/minute or more than 110 times/minute;
7. Patients with tremor disease or chorea disease that are difficult to cooperate in completing the examination while remaining still;
8. Bullous disease or generalized rash, and other patients not suitable for surface electrode recording;
9. Patients with skin allergies to alcohol;
10. Patients with skin infectious diseases;
11. Patients with a history of mental illness or cognitive impairment;
12. Patients who have participated in other clinical trials that may affect this trial within the past 30 days;
13. Concomitant medication that might interfere with study results;
14. Other situations where the researchers consider it inappropriate for a patient to take part in the trial.