Prevention of Atrial Fibrillation After Cardiac Surgery by Pericardiotomy

Changhai Hospital650 enrolled

Overview

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.

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. The study will enrol 650 patients from 15 centres in China. All participants will be continuously monitored using a wearable body surface electrocardiogram (EKG) monitoring equipment from the day of surgery to 30 days after surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

650

Conditions

Atrial Fibrillation (AF)Cardiac Events Pericardial Effusion

Interventions

Posterior pericardiotomyPROCEDURE

The surgeon will perform a posterior pericardiotomy while the patient is on cardiopulmonary bypass. In detail, a 4-cm opening in the posterior pericardium will be made with a cautery between the left inferior pulmonary vein and the diaphragm. Then a soft channel drain will be placed through the opening in pericardium with the tip into the left pleural space.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

Changhai Hospital

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

Postoperative atrial fibrillation

Number of patients with postoperative atrial fibrillation within the 30 days postoperatively

Time frame: Within 30 days after index cardiac surgery

Secondary Outcomes

Atrial fibrillation burden

The proportion of time spent in atrial fibrillation during the total time of cardiac rhythm monitoring within 30 days after the operation, expressed as a percentage.

Time frame: Within 30 days after index cardiac surgery

Heart rate variability

Average HR(bpm), Highest HR(bpm), Lowest HR(bpm), pNN50(%), rMSSD(ms), SDNN(ms)