Effect of Left Posterior Pericardiotomy for the Prevention of POAF

NCT ID: NCT06159985

Last Updated: 2025-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-11

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Artery Disease Atrial Fibrillation New Onset Pericardial Effusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pericardiostomy

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

Group Type ACTIVE_COMPARATOR

left posterior pericardiostomy

Intervention Type 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.

No pericardiostomy

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ho Young Hwang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Ho Young Hwang, MD, PhD

Role: CONTACT

82-2-2072-3020

Suk Ho Sohn, MD

Role: CONTACT

82-2-2072-1949

Facility Contacts

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Ho Young Hwang, MD, PhD

Role: primary

82-2-2072-3020

Suk Ho Sohn, MD

Role: backup

82-2-2072-1949

Other Identifiers

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H-2309-096-1469

Identifier Type: -

Identifier Source: org_study_id

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