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

Effect of Left Posterior Pericardiotomy for the Prevention of Postoperative Atrial Fibrillation in Coronary Artery Bypass Grafting: A Prospective Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Pericardial Effusion; Atrial Fibrillation New Onset
• Intervention / Treatment: Procedure: left posterior pericardiostomy

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 Type: Interventional
• Enrollment (Estimated): 270
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ho Young Hwang, MD, PhD; Phone Number: 82-2-2072-3020; Email: scalpel@snu.ac.kr
• Study Contact Backup: Name: Suk Ho Sohn, MD; Phone Number: 82-2-2072-1949; Email: shsohn@snu.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Ho Young Hwang, MD, PhD; Phone Number: 82-2-2072-3020; Email: scalpel@snu.ac.kr
    • Contact: Suk Ho Sohn, MD; Phone Number: 82-2-2072-1949; Email: shsohn@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pericardiostomy; The patients who were created with left posterior pericardiotomy during the operation	Procedure: left posterior pericardiostomy; 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.
No Intervention: No pericardiostomy; The patients who were not created with left posterior pericardiotomy during the operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
occurence rate of postoperative atrial fibrillation	any short run of atrial fibrillation which occurred during postoperative period before discharge	From date of operation until postoperative day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative mortality	death occurred during the index admission or within 30 days after operation	at 30 days

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 24, 2023
• First Submitted That Met QC Criteria: December 5, 2023
• First Posted (Actual): December 7, 2023

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Atrial Fibrillation; Coronary Artery Disease; Pericardial Effusion
• Other Study ID Numbers: H-2309-096-1469

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: There is a plan to make individual participant data (IPD) and related data dictionaries available.
• IPD Sharing Time Frame: Starting 6 months after publication
• IPD Sharing Access Criteria: IPD will be shared on reasonable request to the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No