Effect of Left Posterior Pericardiotomy for the Prevention of POAF

Seoul National University Hospital270 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

270

Conditions

Coronary Artery Disease Atrial Fibrillation New Onset Pericardial Effusion

Interventions

left posterior pericardiostomyPROCEDURE

In patients assigned to the study group, a 4-5 cm vertical incision posterior to the phrenic nerve and extending from the left inferior pulmonary vein to the diaphragm is performed.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

occurence rate of postoperative atrial fibrillation

any short run of atrial fibrillation which occurred during postoperative period before discharge

Time frame: From date of operation until postoperative day 7

Secondary Outcomes

operative mortality

death occurred during the index admission or within 30 days after operation

Time frame: at 30 days

Central Contacts

Ho Young Hwang, MD, PhD

CONTACT

82-2-2072-3020 scalpel@snu.ac.kr

Suk Ho Sohn, MD

CONTACT

82-2-2072-1949 shsohn@snu.ac.kr

Data from ClinicalTrials.gov

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