An interventional study of Posterior pericardiotomy in Atrial Fibrillation (AF), Cardiac Events and Pericardial Effusion, sponsored by Changhai Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Changhai Hospital · Not applicable, Interventional, and Prevention
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.
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.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 650 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Changhai Hospital is the lead sponsor of 355 studies on the registry; 137 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The surgeon will perform posterior pericardiotomy during the cardiac surgery.
Procedure: Posterior pericardiotomy
The surgeon will not perform posterior pericardiotomy during the cardiac surgery.
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.
Postoperative atrial fibrillation
Number of patients with postoperative atrial fibrillation within the 30 days postoperatively
Time frame: Within 30 days after index cardiac surgery
Atrial fibrillation burden
The proportion of time spent in atrial fibrillation during the total time of cardiac rhythm monitoring within 30 days after the operation, expressed as a percentage.
Time frame: Within 30 days after index cardiac surgery
Heart rate variability
Average HR(bpm), Highest HR(bpm), Lowest HR(bpm), pNN50(%), rMSSD(ms), SDNN(ms)
Time frame: within 30 days of index surgery
Antiarrhythmic drug use
Number of patients received antiarrhythmic drug to control heart rhythm
Time frame: within 30 days of index surgery
Electrical cardioversion
Number of patients received electrical cardioversion for severe heart arrhythmia
Time frame: within 30 days of index surgery
Length of stay in ICU
Length of time in ICU
Time frame: within 30 days of index surgery
Duration of hospitalization
Duration of hospitalization
Time frame: within 30 days of index surgery
Hospital readmission or unplanned hospital visit
Number of hospital readmissions or unplanned hospital visits
Time frame: within 30 days of index surgery
Change in Quality of life
Change in Quality of life assessed by the European quality of life index version 5D (EQ-5D-5L) questionnaire from baseline to 30 days after surgery
Time frame: within 30 days of index surgery
Number of patients with cardiac tamponade
Safety outcome
Time frame: Within 30 days of index surgery
Number of patients with left pleural interventions
Safety outcome
Time frame: Within 30 days of index surgery
Number of patients with phrenic nerve injuries
Safety outcome
Time frame: Within 30 days of index surgery
Number of patients requiring re-operation for bleeding
Safety outcome
Time frame: Within 48 hours of index surgery completion
Ischemic stroke
Safety outcome
Time frame: within 30 days of index surgery
Death
Safety outcome
Time frame: within 30 days of index surgery
Plan to share: Undecided
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