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

NCT05437926 | Unknown

• 1 other identifier: 20-2143-WP
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arrhythmia, Cardiac

Keywords

Descriptive study; Arrhythmia analysis software; Cardiac arrhythmia

Outcome Measures

Primary Outcomes (4)

• Number of participants with Sinus rhythm

  Number of participants with regular sinus P waves (60 to 100 times per minute), P-P distance difference is less than or equal to 0.12s and PR interval \> 0.12s

  During heart rhythm measurement

• Number of participants with Atrial fibrillation

  Number of participants in which the P wave disappears and is replaced by small irregular baseline fluctuations, which vary in shape and amplitude, called f wave; The frequency ranges from 350 to 600 times per minute. The ventricular rate is very irregular, the atrial fibrillation is not treated with drugs, and the atrioventricular conduction is normal, the ventricular rate is usually between 100 and 160 times per minute. The QRS wave morphology is normal. When the ventricular rate is too fast, indoor differential conduction occurs, QRS wave widens and deforms.

  During heart rhythm measurement

• Number of participants with Premature atrial beats

  Number of participants where the appearance of P-QRS-T is early. Note that there is a difference between P-QRS and sinus P-wave shape, which is the important point in identifying atrial premature beats. Sometimes the P wave is hidden in the T wave of the previous cardiac cycle, causing the T wave to be deformed. The interval between P and R is normal and must be greater than or equal to 0.12s. This means that ectopic excitement comes from the atrium and passes through the atrioventricular node. Sometimes the P-R interval is prolonged, which is caused by the atrioventricular node interference. The QRS waveform of ventricular depolarization after atrial premature beat is similar to that of normal sinus conduction. However, sometimes QRS appears wide deformation, called premature atrial beat with intraventricular differential conduction; Atrial premature beat compensation intervals are many incomplete

  During heart rhythm measurement

• Number of participants with Ventricular premature beats

  Number of participants which have a QRS wave with broad deformity, time limit ≥ 0.12 s; There are secondary ST-T changes (the direction of T wave is opposite to that of QRS wave) and complete compensation intervals. There was no P wave before and after the QRS wave in the excitation ventricle. Agitation reverse conducts agitation at the atrial and produces retrograde P' waves (inverted leads II, III, aVF, upright leads aVR), with three manifestations: * (1) retrograde P' wave preceded QRS, P'R interval \< 0.12 s; * (2) There is no P' wave before and after the QRS wave. * (3) Retrograde P' wave after QRS, RP' interval \< 0.20 s; VPM with complete/incomplete compensation intervals consult the investigator whether atrial and ventricular premature beats can be combined into one diagnostic criterion.

  During heart rhythm measurement

Study Arms (2)

Light skin

Light skin Fitzpatrick 1-2 approximately 1/3 with normal sinus rhythm, 1/3 with atrial fibrillation and 1/3 with premature beats

Device: Arrhythmia Analysis Software (software) which runs on a mobile application (Huawei Phone) and uses input from a wearable device (smart watch or smart band).

Dark skin

Dark skin Fitzpatrick 5-6 approximately 1/3 with normal sinus rhythm, 1/3 with atrial fibrillation and 1/3 with premature beats

Device: Arrhythmia Analysis Software (software) which runs on a mobile application (Huawei Phone) and uses input from a wearable device (smart watch or smart band).

Interventions

Arrhythmia Analysis Software (software) which runs on a mobile application (Huawei Phone) and uses input from a wearable device (smart watch or smart band). DEVICE

Subjects with or without cardiac arrhythmias and of light skin tone (melanin index \<150) or dark skin tone (melanin index \>350). Subjects will be divided based on their heart rhythm in three groups: approximately 1/3 with normal sinus rhythm, 1/3 with atrial fibrillation and 1/3 with premature beats

Dark skin; Light skin

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults \>18 years, with or without known heart rhythm irregularities.

You may qualify if:

• Age \>18 of any sex;
• Wrist circumference 140 mm - 210 mm;
• Fitzpatrick skin type 1, 2, 5, or 6 (pre-screening);
• Melanin Index (MI) \<150 or \>350 as measured on the inner arm;
• One of the following conditions, based on past 3 months' history or screening electrocardiogram:
• Normal sinus rhythm;
• Persistent or permanent or onset atrial fibrillation;
• Frequent (\>5 beats per minute) premature beats or ongoing premature beats;
• Willing and able to provide voluntary, written informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Huawei Device Co., Ltd: lead

Study Sites (1)

Maasstad Hospital

Rotterdam, 3079 DZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marcin Meyer

CONTACT

+33 629 02 58 29; marcin.meyer@huawei.com

Caesar Roseboom, PhD

CONTACT

+31 651 722 295; caesar.roseboom@Qservegroup.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 29, 2022
• Study Start: April 21, 2022
• Primary Completion: July 21, 2023
• Study Completion: September 21, 2023
• Last Updated: March 2, 2023

Record last verified: 2023-02

Locations

NL (1)