Effect of Left Posterior Pericardiotomy for the Prevention of POAF

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation New Onset; Pericardial Effusion; Coronary Artery Disease
• Interventions: Procedure: left posterior pericardiostomy

• Registration Number: NCT06159985
• Lead Sponsor: Seoul National University Hospital

Brief Summary

This study is planned to evaluate the effect of left posterior pericardiotomy for the prevention of postoperative atrial fibrillation after coronary artery bypass grafting. Eligible patients will be randomized to be created or not to be created the left posterior pericardiotomy at the end of the operation, and the incidence of postoperative atrial fibrillation will be compared.

Detailed Description

Postoperative atrial fibrillation (POAF) is a common complication after cardiac surgery, particularly after coronary artery bypass grafting (CABG), and is associated with prolonged in-hospital stay and increased adverse outcomes, including death and stroke. There is evidence that pericardial effusion can trigger the occurence of POAF. Therefore, this study is aimed to evaluate the effect of left posterior pericardiotomy for the prevention of POAF after CABG.

Patients who are planned to undergo off-pump CABG will be randomized to be created or not to be created the left posterior pericardiotomy at the end of the operation, and the incidence of postoperative atrial fibrillation will be compared as the primary outcome. Secondary outcomes will include early clinical outcomes and hospital stay.

Study Timeline

• Study First Submitted: 2023-11-24
• Study First Submitted QC: 2023-12-05
• Study First Posted: 2023-12-07
• Study Start: 2023-12-11
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-23
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

• patients who are planned to undergo coronary artery bypass grafting
• patients aged ≥19 years

Exclusion Criteria

• patients who are planned to undergo other concomitant cardiac procedures (e.g. valve procedures, aorta procedures)
• patients who undergo coronary artery bypass grafting using cardiopulmonary bypass
• patients who are documented with paroxysmal, persistent, or permanent atrial fibrillation before operation
• patients who have a history of cardiac surgery
• patients who have a history of pericardial disease
• patients who have severe adhesion at left pleural cavity which precludes effective left posterior pericardiostomy
• patients who refuse to participate in this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pericardiostomy	left posterior pericardiostomy	The patients who were created with left posterior pericardiotomy during the operation

Primary Outcome Measures

Name	Time	Method
occurence rate of postoperative atrial fibrillation	From date of operation until postoperative day 7	any short run of atrial fibrillation which occurred during postoperative period before discharge

Secondary Outcome Measures

Name	Time	Method
operative mortality	at 30 days	death occurred during the index admission or within 30 days after operation

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of