Arrhythmia, CardiacNCT05437926
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
An observational study of Arrhythmia, Cardiac, run by Huawei Device Co., Ltd at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Arrhythmia, Cardiac
- What is being tested?
- Arrhythmia Analysis Software (software) which runs on a mobile application (Huawei Phone) and uses input from a wearable device (smart watch or smart band).
- Type of treatment
- Medical device
- How many people
- 102 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Apr 2022to 21 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults >18 years, with or without known heart rhythm irregularities.
Who may be able to join
- 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;
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- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maasstad Hospital
Rotterdam, 3079 DZ
P.C. Smits, Dr, +31 (0)10 291 22 50, SmitsP@maasstadziekenhuis.nl
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Arrhythmia, Cardiac
- Being tested
- Arrhythmia Analysis Software (software) which runs on a mobile application (Huawei Phone) and uses input from a wearable device (smart watch or smart band).
- Keywords
- Descriptive study, Arrhythmia analysis software, Cardiac arrhythmia
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: During heart rhythm measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start21 Apr 2022
- Primary completion21 Jul 2023 (estimated)
- Study completion21 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmia, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huawei Device Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437926
- Sponsor's protocol ID
- 20-2143-WP
- Status last verified
- Feb 2023
- First submitted
- 23 May 2022
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The results of the research are planned to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05437926
- Acronym / sponsor ID
- 20-2143-WP
- Conditions
- Arrhythmia, Cardiac
- Keywords
- Descriptive study, Arrhythmia analysis software, Cardiac arrhythmia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Huawei Device Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 21 Jul 2023 (estimated)
- Study completion
- 21 Sep 2023 (estimated)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Light skin | – | 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).Light skin Fitzpatrick 1-2 approximately 1/3 with normal sinus rhythm, 1/3 with atrial fibrillation and 1/3 with premature beats |
| Dark skin | – | 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 Fitzpatrick 5-6 approximately 1/3 with normal sinus rhythm, 1/3 with atrial fibrillation and 1/3 with premature beats |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults >18 years, with or without known heart rhythm irregularities.
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arrhythmia Analysis Software (software) which runs on a mobile application (Huawei Phone) and uses input from a wearable device (smart watch or smart band).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 | Device | Dark skin, Light skin |
Primary outcome
Number of participants with Sinus rhythm
Time frame: During heart rhythm measurement
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
Number of participants with Atrial fibrillation
Time frame: During heart rhythm measurement
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.
Number of participants with Premature atrial beats
Time frame: During heart rhythm measurement
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
Number of participants with Ventricular premature beats
Time frame: During heart rhythm measurement
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: Undecided. The results of the research are planned to be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmia, Cardiac, run by Huawei Device Co., Ltd at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcin Meyer (+33 629 02 58 29, marcin.meyer@huawei.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Sinus rhythm (time frame: During heart rhythm measurement). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.