Clinical Study on the Optimization Algorithm of Single-Lead Electrocardiogram Conduction Intervals
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- PR interval
研究概览
简要总结
The goal of this prospective, single-center and observational study is to develop and validate an optimization algorithm for single-lead ECG conduction intervals via the wearable ECG patches combined with synchronized heart sound data, and evaluate its agreement with the clinical gold standard (12-lead ECG) in adult patients. The main question: Does the optimized algorithm, based on ECG patches and synchronous heart sound recordings, improve the detection accuracy of PR interval, QRS duration, and QT interval compared with standard 12-lead ECG? It aims to answer: Participants (age ≥18 years, BMI <35 kg/m², stable sinus rhythm with at least one abnormal conduction interval) will first undergo a 2-minute session of simultaneous ECG patches and digital stethoscope recordings, followed by standard 12-lead ECG, and then the repeated ECG patches and 2-minute heart sound recording session. Data will be used for algorithm training and validation. The primary endpoint is the accuracy of the optimized PR interval, QRS duration, and QT interval detection via the Vivalink ECG patches compared with the 12-lead ECG.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •Able to fully understand the purpose and process of the trial, and willing to sign the informed consent form.
排除标准
- •Physical disabilities that prevent safe and thorough testing;
- •Open wounds on the chest or skin is allergy to patches;
- •Post-implantation of temporary or permanent cardiac pacemaker, ICD, CRT or CRTD, post-replacement of artificial heart valve, with large amounts of pericardial effusion, pericardial tamponade, pleural friction rub, pneumothorax, large amounts of pleural effusion, etc., which may affect data collection;
- •Patients with severe comorbidities or unstable condition, which may interfere with data collection during the study period;
- •Other situations where the investigator believes the subject is not suitable to participate in this trial, such as those that may increase trial risk, affect the protocol compliance, or impair the subject's ability to complete the trial due to physical or psychological diseases or conditions.
结局指标
主要结局
PR interval
时间窗: About half an hour
QRS duration
时间窗: About half an hour
QT interval
时间窗: About half an hour
PR interval
时间窗: 10-15 minutes
QRS duration
时间窗: 10-15 minutes
QT interval
时间窗: 10-15 minutes
次要结局
未报告次要终点