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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06159985
Other study ID # H-2309-096-1469
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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