Partial Cardiac Denervation to Prevent POAF After CABG: 3 Year Follow-up of pCAD-POAF Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 430
- 试验地点
- 1
- 主要终点
- AF burden
研究概览
简要总结
This study will include the subjects who enrolled in pCAD-POAF trial (NCT05009914) to observe clinical outcomes 3 years after surgery.
The primary outcome is the AF burden during 3-day continuous ECG monitoring among 2 groups in pCAD-POAF trial 3 years after surgery.
The secondary outcomes are：1. Freedom of AF without the use of antiarrhymic medications or interventions ; 2. The occurence of MACCE (including all-cause mortality, stroke, myocardial infarction, systemic arterial embolism, revascularization, and rehospitalization for heart failure); 3. AF incidence in 3 years and recorded by continuous ECG monitoring; 4. Post-operative antiarrhythmic interventions and occurrence of arrhythmias other than AF; 5. The mean, maximum, and minimum heart rate recorded by Holter monitoring, as well as heart rate variability (HRV); 6. Quality of life assessment, such as EQ-5D-5L and AFEQT.
详细描述
This study aimed to observe clinical outcomes 3 years after surgery in patients enrolled in pCAD-POAF trial.
After completing the pCAD-POAF trial, investigators would not make any other interventions on enrolled patients. At the 3 year follow-up visit, all subjects will undergo regular laboratory test , electrocardiogram (ECG), ultrasound cardiography (UCG). Besides, coronary computed tomographic angiography(CCTA) will be performed depending on their own willingness. In the meantime, all subjects will be continuously monitored by wearing specific device for the detection of arrhythmias. Data collection will also include the use of medications, medical tests, any documented arrhythmias and the occurrence of clinical events within the 3 years.
In conclusion, this is a extensive follow-up of previous RCT and a non-interventional, observational study.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This study will include the subjects who enrolled in pCAD-POAF trial
排除标准
- •This study will include the subjects who enrolled in pCAD-POAF trial
结局指标
主要结局
AF burden
时间窗: 3 year after the surgery
the AF burden during 3-day continuous ECG monitoring among 2 groups at the 3 year follow-up.
次要结局
- Freedom of AF without the use of antiarrhymic medications or interventions(within 3 year after surgery)
- The occurence of MACCE(within 3 year after surgery)
- AF incidence in 3 years and recorded by continuous ECG monitoring(3 year after the surgery)
- Post-operative antiarrhythmic interventions and occurrence of arrhythmias other than AF(within 3 year after surgery)
- The mean, maximum, and minimum heart rate and HRV(3 year after the surgery)
- Assessment of quality of life(3 year after the surgery)