Coronary Artery DiseaseELIMINATE-AFNCT06159985
Effect of Left Posterior Pericardiotomy for the Prevention of POAF
A study testing left posterior pericardiostomy in people with Coronary Artery Disease and Atrial Fibrillation New Onset, run by Seoul National University Hospital at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease, Atrial Fibrillation New Onset, Pericardial Effusion
- What is being tested?
- left posterior pericardiostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Dec 2023to 23 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who are planned to undergo coronary artery bypass grafting
- patients aged ≥19 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- left posterior pericardiostomy
- Medical subject headings
- Coronary Artery Disease, Pericardial Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
left posterior pericardiostomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Pericardiostomy | Active comparator | The patients who were created with left posterior pericardiotomy during the operation Receives: Procedure: left posterior pericardiostomy |
| No pericardiostomy | No intervention | The patients who were not created with left posterior pericardiotomy during the operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurence rate of postoperative atrial fibrillation
any short run of atrial fibrillation which occurred during postoperative period before discharge
Measured: From date of operation until postoperative day 7
Secondary outcomes (1)
operative mortality
death occurred during the index admission or within 30 days after operation
Measured: at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start11 Dec 2023
- Primary completion9 Dec 2025
- Study completion23 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Young Hwang, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159985
- Sponsor's protocol ID
- H-2309-096-1469
- Acronym
- ELIMINATE-AF
- Status last verified
- Jun 2026
- First submitted
- 24 Nov 2023
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make individual participant data (IPD) and related data dictionaries available.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Left Posterior Pericardiotomy for the Prevention of Postoperative Atrial Fibrillation in Coronary Artery Bypass Grafting: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06159985
- Acronym / sponsor ID
- ELIMINATE-AF / H-2309-096-1469
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 9 Dec 2025 (actual)
- Study completion
- 23 Dec 2025 (actual)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pericardiostomy | Active comparator | Procedure: left posterior pericardiostomyThe patients who were created with left posterior pericardiotomy during the operation |
| No pericardiostomy | No intervention | –The patients who were not created with left posterior pericardiotomy during the operation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients who are planned to undergo coronary artery bypass grafting
- patients aged ≥19 years
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| left posterior pericardiostomyIn 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. | Procedure or surgery | Pericardiostomy |
Primary outcome
occurence rate of postoperative atrial fibrillation
Time frame: From date of operation until postoperative day 7
any short run of atrial fibrillation which occurred during postoperative period before discharge
1 secondary outcome
operative mortality
Time frame: at 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Yes. There is a plan to make individual participant data (IPD) and related data dictionaries available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing left posterior pericardiostomy in people with Coronary Artery Disease and Atrial Fibrillation New Onset, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurence rate of postoperative atrial fibrillation (time frame: From date of operation until postoperative day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.