NCT06728826

Prevention of Atrial Fibrillation After Cardiac Surgery by Posterior Pericardiotomy

Prevention of Atrial Fibrillation After Cardiac Surgery by Posterior Pericardiotomy: a Muticentre Randomized Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 648 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of PREACT-AF is to learn if posterior pericardiotomy works to prevent the incidence of postoperative atrial fibrillation (POAF) in patients undergoing cardiac surgery. The main questions it aims to answer are: Does posterior pericardiotomy prevent the incidence of POAF for participants after cardiac surgery? What medical problems do participants have when undergoing posterior pericardiotomy?

Detailed description

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. The study will enrol 1400 patients from 30 centres, globally. Follow-up visits will be performed in person or by telephone 1 and 6 months post-randomization (+7 days), and then every 6 months (+30 days) until an average follow-up of 5 years for the study participants (estimated to be 4 years after completion of enrolment).

Conditions

• Atrial Fibrillation (AF)
• Cardiac Events

Interventions

Type	Name	Description
PROCEDURE	Posterior Pericardiotomy	The surgeon will perform a posterior pericardiotomy while the patient is on cardiopulmonary bypass. In detail, the surgeon will use cautery to make a 4- to 5-cm opening in pericardium between the left inferior pulmonary vein and the diaphragm. Then a soft channel drain will be placed through the posterior pericardium, the pericardiotomy and into the left pleural space.

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2024-12-11
• Last updated: 2024-12-11

Locations

1 site across 1 country: China