Clinical Trial for Evaluating the Effectiveness and Safety of the Pulse Wave-based Atrial Fibrill… (NCT07078071) | Clinical Trial Compass
CompletedNot Applicable
Clinical Trial for Evaluating the Effectiveness and Safety of the Pulse Wave-based Atrial Fibrillation and Premature Beat Alert Software
China199 participantsStarted 2022-10-18
Plain-language summary
This study aims to validate the efficacy and safety of the Pulse Wave-based Atrial Fibrillation and Premature Beat Alert Software (Huawei Device Co., Ltd.). This software can provide alerts, store and display PPG data transmitted from smartwatches or fitness trackers. The software is limited to alerting of atrial fibrillation and premature beat, and the results are only for clinical reference.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients over 18 years old, regardless of gender;
. Participants who meet one of the following conditions according to the medical history in the past 3 months or the ECG during the screening period:
. Patients with normal sinus rhythm;
. Patients with persistent or permanent paroxysmal atrial fibrillation or in the onset of paroxysmal atrial fibrillation;
. Patients with frequent premature beats (more than 5 per minute) or in the onset of premature beats;
. Patients who volunteer to participate and have signed an informed consent form.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensitivity and specificity of atrial fibrillation identification in a single measurement
Timeframe: 45seconds
2
Sensitivity and specificity of premature beat identification in a single measurement
. Patients using cardiac pacemakers or implantable cardioverter defibrillators (ICD);
. Patients with non-respiratory sinus arrhythmia, sinus arrest or sick sinus syndrome according to the ECG results during the screening period;
. Patients with interpolated premature beats, junctional premature beats, or escape rhythms according to the ECG results during the screening period;
. Patients with atrial flutter, ventricular flutter, or ventricular fibrillation according to the ECG results during the screening period;
. Patients with atrial fibrillation or premature beats who have a resting heart rate of slower than 50 beats/minute or faster than 110 beats/minute according to the ECG results during the screening period;
. Patients who are critically ill, making it difficult to make an accurate assessment of the effectiveness and safety of the device;
. Patients who suffer from tremor diseases or chorea, making it difficult to complete the examination quietly;
. Patients with bullous diseases or large-area skin rashes that are not suitable for body surface electrode recording;