The goal of this observational study is to develop and validate an optimization algorithm for single-lead ECG conduction intervals using a wearable ECG patch combined with synchronized heart sound data, and to evaluate its agreement with the clinical gold standard (12-lead ECG) in adult patients. The main question it aims to answer is:
Does the optimized algorithm, based on ECG patch and synchronous heart sound recordings, improve the detection accuracy of PR interval, QRS duration, and QT interval compared to standard 12-lead ECG?
Participants (age ≥18 years, BMI \<35 kg/m², stable sinus rhythm with at least one abnormal conduction interval) will undergo two 2-minute sessions of simultaneous ECG patch and digital stethoscope recordings, followed by standard 12-lead ECG. Data will be used for algorithm training and validation, with primary endpoints being the sensitivity and specificity of the optimized intervals against the gold standard.
Age ≥18 years;
body mass index < 35 kg/m2;
with stable sinus rhythm;
PR interval, QRS duration, or QT interval were stable and at least one was outside the normal range;
There are physical disabilities that prevent safe and thorough testing;
Open wounds on the chest skin or skin allergy to patches;
Post-implantation of temporary or permanent cardiac pacemaker, ICD, CRT or CRTD, after artificial heart valve replacement, with large amounts of pericardial effusion, pericardial tamponade, pleural friction rub, pneumothorax, large amounts of pleural effusion, etc., which may affect data collection;
The patient has severe comorbidities or unstable condition, which may interfere with data collection during the study period;
The subjects were selected from those who were aged 18 years or above, had a body mass index of less than 35 kg/m2, had stable sinus rhythm; and whose PR interval, QRS duration or QT interval were stable but at least one of them was outside the normal range. They also had a full understanding of the trial purpose and process and voluntarily signed the informed consent form.
Cohort
Prospective
Not listed
PR intervals
QRS duration
QT interval
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