Pericardiotomy in Cardiac Surgery Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,400
- 试验地点
- 8
- 主要终点
- Hierarchical composite of all-cause death, ischemic stroke, systemic arterial embolism, unplanned hospital visit/readmission for cardiac reasons, and atrial fibrillation.
研究概览
简要总结
PRINCE is an international, multicentre, randomized controlled trial of posterior pericardiotomy in patients without a history of atrial fibrillation (AF) or flutter undergoing cardiac surgery.
详细描述
Approximately 30% of cardiac surgical patients develop post-operative atrial fibrillation (POAF). Its incidence varies depending on the type of cardiac operation. POAF is associated with short- and long-term adverse events, including mortality, stroke, and heart failure. POAF has also been significantly associated with unplanned hospitalization for heart failure.
During cardiac surgery, pericardial fluid tends to collect posterior to the left atrium. Even small amounts of fluid may trigger atrial arrhythmias. A posterior left pericardiotomy is a surgical procedure that involves cauterizing an opening between the left inferior pulmonary vein and the diaphragm. This procedure may allow for more prolonged drainage of the pericardial fluid into the left pleural space. Recent research evidence found that posterior pericardiotomy was associated with a significantly lower incidence of POAF.
The existing data on posterior pericardiotomy is promising for a reduction in POAF. However, no high-quality study has demonstrated that this reduction improves clinical outcomes in the years after cardiac surgery. The PRINCE trial's long-term follow-up of patients randomized to left posterior pericardiotomy could conclusively demonstrate whether the relationship of POAF to post-discharge clinical outcomes is causal and modifiable.
The PRINCE trial will evaluate the effectiveness and safety of posterior left pericardiotomy in preventing POAF and improving post-discharge clinical outcomes in a broad spectrum of cardiac surgery patients.
The intervention under investigation is left posterior pericardiotomy which is compared to no posterior pericardiotomy during cardiac surgery. The early co-primary outcome is in-hospital POAF, and the late co-primary outcome is the hierarchical composite of time to all-cause death, time to ischemic stroke, time to systemic arterial embolism, time to unplanned hospital visit/readmission for cardiac reasons, and time to atrial fibrillation after index hospital discharge.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Blinding to allocation will be maintained for all parties, excluding the operating surgeon and necessary operating room personnel.
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 greater than or equal to 18 years of age
- •Requiring surgical intervention on the proximal aorta, cardiac valves, and/or coronary arteries
- •Able to provide informed consent
排除标准
- •History of atrial fibrillation or flutter
- •Cardiac surgery procedures not included in the inclusion criteria (planned ventricular assistance device, aortic arch, transplantation surgery)
- •Prior cardiac surgery requiring opening of the pericardium
- •Previous surgical instrumentation of the left pleural cavity
- •Patient undergoing minimally invasive cardiac surgery
结局指标
主要结局
Hierarchical composite of all-cause death, ischemic stroke, systemic arterial embolism, unplanned hospital visit/readmission for cardiac reasons, and atrial fibrillation.
时间窗: Over the duration of the follow-up period to a common end date (mean follow-up of 5 years).
Number of patients with a composite of all-cause death, ischemic stroke, systemic arterial embolism, unplanned hospital visit/readmission for cardiac reasons, and atrial fibrillation events, evaluated using the win ratio (thereby accounting for the difference in importance of these outcomes).
In-hospital post-operative atrial fibrillation
时间窗: Within 5 days after index cardiac surgery
Number of patients with post-operative atrial fibrillation within the first 5 days postoperatively or up to hospital discharge, whichever occurs first
次要结局
- Post-operative atrial fibrillation (POAF)(Over the duration of the follow-up period to a common end date (mean follow-up of 5 years).)
- Length of post-operative in-hospital stay(Over the duration of the follow-up period to a common end date (mean follow-up of 5 years).)
- Pericardial effusion without tamponade(From index surgery completion to within 30 days of index surgery)
- Death(From index surgery completion to within 30 days of index surgery)
- Ischemic stroke or systemic arterial embolism(From index surgery completion to within 30 days of index surgery)
- Hospital readmission or unplanned hospital visit(From index surgery completion to within 30 days of index surgery)
- Quality of life assessed by the European quality of life index version 5D (EQ-5D-5L) questionnaire(Over the duration of the follow-up (mean follow-up of 5 years))