Sinus rhythm and atrial fibrillation in adult populations
Conditions
Interventions
Experimental equipment:The subject simultaneously uses the test device and the control method to measure ECG, meaning the same subject needs to wear both the test device with its accompanying Xiaomi w
Sponsors
Beijing Anzhen Hospital,Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18 or over; 2. Subjects who have been confirmed to meet one of the following conditions based on their medical history within three months prior to enrollment or through a 12-lead ECG examination conducted during the screening period: Persistent atrial fibrillation (including permanent atrial fibrillation) or an episode of paroxysmal atrial fibrillation; Sinus rhythm; 3.Subjects and/or their legally authorized representatives can understand the objectives of the study, show sufficient compliance with the study protocol, and sign the informed consent forms.
Exclusion criteria
Exclusion criteria: 1. Subjects with a cardiac pacemaker or an implantable cardioverter-defibrillator (ICD); 2. Subjects with an average resting heart rate below 50 bpm or above 150 bpm; 3. Subjects with other arrhythmias than atrial fibrillation detected during the 12-lead ECG examination in the screening period; 4. Subjects with tremor disorders or chorea who have difficulty remaining still and cooperating during the examination; 5. Subjects with infection or inflammation at the ECG electrode placement sites, who are anticipated to be unable to complete the ECG examination due to these conditions; 6.Subjects with a history of allergy to ECG electrodes; 7. Other circumstances in which the investigator, after carefully evaluating the best interests of the subject, determines that the subject’s participation in this clinical study is not advisable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive Predictive Value (PPV);Overall Percent Agreement (OPA);Kappa coefficient (k);Feature waveform similarity rate;R-wave amplitude consistency rate;Heart rate measurement accuracy;Operational performance; | — |
Countries
China
Contacts
Public ContactSang Caihua
Beijing Anzhen Hospital,Capital Medical University
Outcome results
None listed