NCT06206187尚未招募不适用
ICE Detector-RCT: Blinded, Randomized Controlled Trial of Electrophysiologist vs. Artificial Intelligence Detection of Intracardiac Thrombus
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Degree of change from initial (AI vs EP doctor) assessment to final cardiologist assessment
研究概览
简要总结
To determine whether an integrated AI decision support can save time and improve the accuracy of detection of intracardiac thrombus, the investigators are conducting a blinded, randomized controlled study of AI-guided detection of intracardiac thrombus to electrophysiologist judgment in preliminary readings of echocardiograms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-80 years.
- •Willing to sign informed consent.
- •Patients diagnosed with atrial fibrillation Paroxysmal AF and Persistent AF according to the latest clinical guidelines
排除标准
- •End-stage disease with a mean life expectancy less than 1 year
- •New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction less than 30%
- •Previous surgical or catheter ablation for AF
- •Bradycardia and presence of implanted ICD
- •Uncontrolled hypertension: Systolic blood pressure (SBP) >180 mmHg or diastolic blood pressure (DBP) > 110 mmHg
- •Patients with Cardiovascular events including acute myocardial infarction, any PCI, valvular cardiac surgical, or percutaneous procedure within the past 3 months
- •Women of childbearing potential who are, or plan to become, pregnant during the time of the study
- •Have been enrolled in an investigational study evaluating devices or drugs.
结局指标
主要结局
Degree of change from initial (AI vs EP doctor) assessment to final cardiologist assessment
时间窗: 10 Minutes
次要结局
- Perioperative adverse event rates(10 Minutes)
研究者
Xu Liu
professor
Shanghai Chest Hospital
研究点 (1)
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