Effect of Left Posterior Pericardiotomy for the Prevention of POAF

Coronary Artery Disease Clinical Trial

— ELIMINATE-AF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06159985
• Other study ID #: H-2309-096-1469
• Status: Recruiting
• Phase: N/A
• Start date: December 11, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Seoul National University Hospital
• Contact: Ho Young Hwang, MD, PhD
• Phone: 82-2-2072-3020
• Email: scalpel[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation New Onset
• Coronary Artery Disease
• Pericardial Effusion

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	operative mortality	death occurred during the index admission or within 30 days after operation	at 30 days