Pericardiotomy for Prevention of Postoperative Atrial Fibrillation After Cardiac Surgery in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 650
- 试验地点
- 1
- 主要终点
- Postoperative atrial fibrillation
研究概览
简要总结
PRINCE-CH is a multicentre, randomized controlled trial which evaluates the effectiveness and safety of posterior pericardiotomy in preventing POAF after cardiac surgery in Chinese population.
详细描述
Postoperative atrial fibrillation (POAF), defined as new-onset atrial fibrillation (AF) in the immediate period after surgery, is the most important type of secondary AF, which complicates 20-40% patients receiving cardiac surgery.
POAF is associated with haemodynamic instability , increased risk of stroke, lengthened hospital and intensive care unit stays and greater costs.
Pericardial effusion accumulated posterior to the left atrium after cardiac surgery could trigger atrial arrhythmias. Pericardiotomy allows for prolonged drainage of the pericardial effusion into left pleural space. Recent research evidence found that pericardiotomy was associated with a significantly lower incidence of POAF. The existing data on posterior pericardiotomy is promising for a reduction in POAF. The PRINCE trial's long-term follow-up of patients randomized to pericardiotomy could conclusively demonstrate whether the relationship of POAF to post-discharge clinical outcomes is causal and modifiable.
The PRINCE-CH trial will evaluate the effectiveness and safety of pericardiotomy in preventing POAF after cardiac surgery in Chinese population.
The intervention is posterior pericardiotomy and the control is no posterior pericardiotomy during cardiac surgery. The primary outcome is the occurrence of POAF.
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
- Triple (Participant, Investigator, 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 older than or equal to 18 years of age
- •Requiring surgical intervention on proximal aorta, cardiac valves, and/or coronary arteries
- •Able to provide informed consent
排除标准
- •History of atrial fibrillation or flutter
- •Reoperations/minimally invasive cardiac surgery/emergent presentation
- •Need for hypothermic circulatory arrest
- •Disease of the left pleura or previous left thoracotomy
- •Chest deformity
- •Unlikely to participate in follow-up assessments
研究组 & 干预措施
Pericardiotomy Group
The surgeon will perform posterior pericardiotomy during the cardiac surgery.
干预措施: Posterior pericardiotomy (Procedure)
Control Group
The surgeon will not perform posterior pericardiotomy during the cardiac surgery.
结局指标
主要结局
Postoperative atrial fibrillation
时间窗: Within 30 days after index cardiac surgery
Number of patients with postoperative atrial fibrillation within the 30 days postoperatively
次要结局
- Atrial fibrillation burden(Within 30 days after index cardiac surgery)
- Heart rate variability(within 30 days of index surgery)
- Antiarrhythmic drug use(within 30 days of index surgery)
- Electrical cardioversion(within 30 days of index surgery)
- Length of stay in ICU(within 30 days of index surgery)
- Duration of hospitalization(within 30 days of index surgery)
- Hospital readmission or unplanned hospital visit(within 30 days of index surgery)
- Change in Quality of life(within 30 days of index surgery)