NCT05482503CompletedNot Applicable
Clinical Investigation to Evaluate the Effectiveness and Safety of ECG App
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Huawei Device Co., Ltd
- Enrollment
- 673
- Locations
- 2
- Primary Endpoint
- Sensitivity and specificity of atrial fibrillation identification
Study Overview
Brief Summary
The purpose of this study is to verify the effectiveness and safety of the Huawei Device software (ECG APP), which can be used to analyze, store and display the ECG data transmitted by the single-lead ECG acquisition device. The software can be used for the analysis of sinus rhythm, atrial fibrillation, and premature beats(ventricular premature beats and atrial premature beats) in adults.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 have good compliance, and can cooperate to complete this research by himself/herself; 4）Patients who volunteer to participate and have signed an informed consent form.
Exclusion Criteria
- •Patients using cardiac pacemakers or implantable cardioverter defibrillators (ICD);
- •Patients with atrioventricular block or bundle branch block;
- •Patients with significant sinus arrhythmia, sinus arrest or sick sinus syndrome;
- •Patients with interpolated premature beats, junctional premature beats, or escape rhythms;
- •Patients with atrial tachycardia, atrial flutter, ventricular tachycardia, ventricular flutter, or ventricular fibrillation;
- •Patients with a resting heart rate of slower than 50 beats/minute or faster than 110 beats/minute;
- •Patients with atrial fibrillation complicated with premature beats;
- •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;
- •Patients whose skin is allergic to ethanol;
- •Patients with contagious skin diseases;
- •Patients with a history of mental illness or with cognitive impairment;
- •Patients who have participated in other clinical investigations within the past 30 days that may affect this investigation; 15） Other conditions that the investigators consider inappropriate for participation in the investigation.
Arms & Interventions
Atrial Fibrillation
Experimental
Intervention: 12-Lead ECG(I-lead) (Device)
Premature beats
Experimental
Intervention: 12-Lead ECG(I-lead) (Device)
Sinus Rhythm
Experimental
Intervention: 12-Lead ECG(I-lead) (Device)
Outcomes
Primary Outcomes
Sensitivity and specificity of atrial fibrillation identification
Time Frame: 30seconds
Sensitivity and specificity of sinus rhythm identification
Time Frame: 30seconds
Sensitivity and specificity of premature beat identification
Time Frame: 30seconds
Secondary Outcomes
- Heart rate accuracy(30seconds)
- Detection rate of ventricular premature beats and atrial premature beats(30seconds)
- ECG waveform similarity(30seconds)
- R wave amplitude consistency(30seconds)
- Total coincidence rate of measurement and identification(30seconds)
- Software usability(30seconds)
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Recruiting
Not Applicable
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 PatientsArrhythmia, CardiacNCT05437926Huawei Device Co., Ltd102
Completed
Not Applicable
MiniMed™ 670G System China Study for Type I DiabeticDiabetes Mellitus, Type 1NCT04663295Medtronic Diabetes74
Completed
Not Applicable
Safety and Effectiveness of an Auricular SprayExcessive Ear WaxNCT06085443YSLab99
Completed
Not Applicable
The Oral Accessibility Spatula (Spatule SAB)Mental HandicapNCT02818374Centre Hospitalier Régional Metz-Thionville200
Not yet recruiting
Not Applicable
Study on the Efficacy and Safety of a Device for Post-op Recovery in Pediatric Adenectomy/Adenotonsillectomy.Nasal DiseaseAdenoidal DisorderOtorhinolaryngologic DiseasesTonsillitisNCT06478433Pharmaluce srl90