Effect of Left Posterior Pericardiotomy for the Prevention of POAF (ELIMINATE-AF)

Seoul National University

Status: Enrolling

Conditions: Pericardial Effusion; Coronary Artery Disease; Atrial Fibrillation New Onset

Treatments: Procedure: left posterior pericardiostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06159985

H-2309-096-1469

Details and patient eligibility

About

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.

Full 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.

Enrollment: 270 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 2 patient groups

Pericardiostomy

Active Comparator group

Description:

The patients who were created with left posterior pericardiotomy during the operation

Treatment:

Procedure: left posterior pericardiostomy

No pericardiostomy

No Intervention group

Description:

The patients who were not created with left posterior pericardiotomy during the operation