Prevention of Atrial Fibrillation After Cardiac Surgery by Posterior Pericardiotomy
NCT ID: NCT06728826
Last Updated: 2024-12-11
Study Results
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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NOT_YET_RECRUITING
NA
648 participants
INTERVENTIONAL
2025-01-31
2026-06-30
Brief Summary
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The main questions it aims to answer are:
Does posterior pericardiotomy prevent the incidence of POAF for participants after cardiac surgery? What medical problems do participants have when undergoing posterior pericardiotomy?
Detailed Description
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During cardiac surgery, pericardial fluid tends to collect posterior to the left atrium. Even small amounts of fluid may trigger atrial arrhythmias. A posterior left pericardiotomy is a surgical procedure that involves cauterizing an opening between the left inferior pulmonary vein and the diaphragm. This procedure may allow for more prolonged drainage of the pericardial fluid into the left pleural space. Recent research evidence found that posterior pericardiotomy was associated with a significantly lower incidence of POAF.
The existing data on posterior pericardiotomy is promising for a reduction in POAF. However, no high-quality study has demonstrated that this reduction improves clinical outcomes in the years after cardiac surgery. The PRINCE trial's long-term follow-up of patients randomized to left posterior pericardiotomy could conclusively demonstrate whether the relationship of POAF to post-discharge clinical outcomes is causal and modifiable.
The PRINCE trial will evaluate the effectiveness and safety of posterior left pericardiotomy in preventing POAF and improving post-discharge clinical outcomes in a broad spectrum of cardiac surgery patients.
The intervention under investigation is left posterior pericardiotomy which is compared to no posterior pericardiotomy during cardiac surgery. The early co-primary outcome is in-hospital POAF, and the late co-primary outcome is the hierarchical composite of time to all-cause death, time to ischemic stroke, time to systemic arterial embolism, time to unplanned hospital visit/readmission for cardiac reasons, and time to atrial fibrillation after index hospital discharge.
The study will enrol 1400 patients from 30 centres, globally. Follow-up visits will be performed in person or by telephone 1 and 6 months post-randomization (+7 days), and then every 6 months (+30 days) until an average follow-up of 5 years for the study participants (estimated to be 4 years after completion of enrolment).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Posterior Pericardiotomy Group
The surgeon will perform posterior pericardiotomy during the patient's cardiac surgery.
Posterior Pericardiotomy
The surgeon will perform a posterior pericardiotomy while the patient is on cardiopulmonary bypass. In detail, the surgeon will use cautery to make a 4- to 5-cm opening in pericardium between the left inferior pulmonary vein and the diaphragm. Then a soft channel drain will be placed through the posterior pericardium, the pericardiotomy and into the left pleural space.
No Posterior Pericardiotomy Group
The surgeon will not perform posterior pericardiotomy during the patient's cardiac surgery.
No interventions assigned to this group
Interventions
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Posterior Pericardiotomy
The surgeon will perform a posterior pericardiotomy while the patient is on cardiopulmonary bypass. In detail, the surgeon will use cautery to make a 4- to 5-cm opening in pericardium between the left inferior pulmonary vein and the diaphragm. Then a soft channel drain will be placed through the posterior pericardium, the pericardiotomy and into the left pleural space.
Eligibility Criteria
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Inclusion Criteria
* Requiring surgical intervention on the proximal aorta, cardiac valves, and/or coronary arteries
* Able to provide informed consent
* Prior cardiac surgery requiring opening of the pericardium
* Previous surgical instrumentation of the left pleural cavity
* Patient undergoing minimally invasive cardiac surgery
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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Principal Investigators
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Lin Han, M.D. Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Naval Medical University Changhai Hospital
Hao Zhang, M.D. Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Naval Medical University Changhai Hospital
Locations
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Changhai Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Fan Yang, M.D. Ph.D.
Role: primary
Other Identifiers
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CHEC2024-397
Identifier Type: -
Identifier Source: org_study_id