Prevention of Atrial Fibrillation After Cardiac Surgery by Pericardiotomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Posterior pericardiotomy.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF), Cardiac Events, Pericardial Effusion. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pericardiotomy for Prevention of Postoperative Atrial Fibrillation After Cardiac Surgery in China
Overview
PRINCE-CH is a multicentre, randomized controlled trial which evaluates the effectiveness and safety of posterior pericardiotomy in preventing POAF after cardiac surgery in Chinese population.
Detailed description
Postoperative atrial fibrillation (POAF), defined as new-onset atrial fibrillation (AF) in the immediate period after surgery, is the most important type of secondary AF, which complicates 20-40% patients receiving cardiac surgery.
POAF is associated with haemodynamic instability , increased risk of stroke, lengthened hospital and intensive care unit stays and greater costs.
Pericardial effusion accumulated posterior to the left atrium after cardiac surgery could trigger atrial arrhythmias. Pericardiotomy allows for prolonged drainage of the pericardial effusion into left pleural space. Recent research evidence found that pericardiotomy was associated with a significantly lower incidence of POAF. The existing data on posterior pericardiotomy is promising for a reduction in POAF. The PRINCE trial's long-term follow-up of patients randomized to pericardiotomy could conclusively demonstrate whether the relationship of POAF to post-discharge clinical outcomes is causal and modifiable.
The PRINCE-CH trial will evaluate the effectiveness and safety of pericardiotomy in preventing POAF after cardiac surgery in Chinese population.
The intervention is posterior pericardiotomy and the control is no posterior pericardiotomy during cardiac surgery. The primary outcome is the occurrence of POAF.
The study will enrol 650 patients from 15 centres in China. All participants will be continuously monitored using a wearable body surface electrocardiogram (EKG) monitoring equipment from the day of surgery to 30 days after surgery.
Interventions
- Procedure Posterior pericardiotomy
The surgeon will perform a posterior pericardiotomy while the patient is on cardiopulmonary bypass. In detail, a 4-cm opening in the posterior pericardium will be made with a cautery between the left inferior pulmonary vein and the diaphragm. Then a soft channel drain will be placed through the opening in pericardium with the tip into the left pleural space.
Primary outcome measures
- Postoperative atrial fibrillation [Time frame: Within 30 days after index cardiac surgery]
Secondary outcome measures (8)
- Atrial fibrillation burden [Time frame: Within 30 days after index cardiac surgery]
- Heart rate variability [Time frame: within 30 days of index surgery]
- Antiarrhythmic drug use [Time frame: within 30 days of index surgery]
- Electrical cardioversion [Time frame: within 30 days of index surgery]
- Length of stay in ICU [Time frame: within 30 days of index surgery]
- Duration of hospitalization [Time frame: within 30 days of index surgery]
- Hospital readmission or unplanned hospital visit [Time frame: within 30 days of index surgery]
- Change in Quality of life [Time frame: within 30 days of index surgery]
Eligibility criteria
Inclusion criteria
- Patients older than or equal to 18 years of age
- Requiring surgical intervention on proximal aorta, cardiac valves, and/or coronary arteries
- Able to provide informed consent
Exclusion criteria
- History of atrial fibrillation or flutter
- Reoperations/minimally invasive cardiac surgery/emergent presentation
- Need for hypothermic circulatory arrest
- Disease of the left pleura or previous left thoracotomy
- Chest deformity
- Unlikely to participate in follow-up assessments
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Changhai Hospital — Shanghai
Identifiers
NCT: NCT06728826 · CHEC2025-290