NCT05009914已完成不适用
Assessing a New Way of Cardiac Denervation to Reduce the Incidence of Atrial Fibrillation After Coronary Artery Bypass Grafting.
China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 430 人开始时间: 2022年8月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 430
- 试验地点
- 1
- 主要终点
- Incidence of POAF during hospital.
研究概览
简要总结
This is a prospective, random controlled trial(RCT) study. 430 patients undergoing coronary artery bypass grafting were enrolled. Our new way of cardiac denervation, defined as excision of Marshall ligament and Waterstone fat pad, was performed in 215 patients, and the other 215 patients were used as control subjects. All the patients need to equip with electronic monitor to record heart rhythms within 6 days after CABG. The investigators will compare the incidence of postoperative atrial fibrillation between two groups, and follow up 30 days after discharged.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Patients undergoing simple CABG (on-pump/off-pump) for the first time.
- •Patients who signed the informed consent form and willing to undergo cardiac denervation.
排除标准
- •Emergent CABG;
- •Cardiac surgery history；
- •Receiving other cardiac surgery except of CABG at the same time, such as Morrow、valvular surgery、ventricular aneurysm surgery、congenital heart diseases surgery；
- •Requiring mechanical or pharmacological therapy for hemodynamic support before CABG, such as ECMO or IABP;
- •History of AF ;
- •Taking antiarrhythmic agents except of beta-blockers last 2 weeks.
结局指标
主要结局
Incidence of POAF during hospital.
时间窗: 6 days after surgery.
Incidence of postoperative atrial fibrillation after surgery during hospital.
次要结局
- Incidence of re-operation aiming to stop bleeding caused by cardiac denervation.(Postoperative hospitalization, an average of 8 days.)
- Incidence of massive haemorrhage needing blood transfusion caused by cardiac denervation.(Postoperative hospitalization, an average of 8 days.)
- Incidence of transferring to on-pump CABG caused by cardiac denervation.(Intraoperatively.)
- All cost after surgery.(Postoperative hospitalization, an average of 8 days.)
- Incidence of pericarial effusion within 30 days after discharged.(within 30 days after discharged.)
- Incidence of arrhythmia exclude of AF within 30 days after discharged.(within 30 days after discharged.)
- Postoperative length of hospitalization.(Postoperative hospitalization, an average of 8 days.)
- MACCE(within 30 days after discharged.)
研究者
研究点 (1)
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