Effect of Left Posterior Pericardiotomy for the Prevention of POAF

NCT06159985 | Recruiting DMC

• 1 other identifier: H-2309-096-1469
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Atrial Fibrillation New Onset; Pericardial Effusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• operative mortality

  at 30 days

Study Arms (2)

Pericardiostomy

ACTIVE COMPARATOR

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

Procedure: left posterior pericardiostomy

No pericardiostomy

NO INTERVENTION

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

Interventions

left posterior pericardiostomy PROCEDURE

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.

Pericardiostomy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Pericardial Effusion

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: December 7, 2023
• Study Start: December 11, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Starting 6 months after publication
• Access Criteria: IPD will be shared on reasonable request to the corresponding author.

Locations

KR (1)