An interventional study of Left Posterior Pericardiotomy in Atrial Fibrillation, Atrial Flutter and Cardiac Events, sponsored by Population Health Research Institute. Recruiting at 19 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Population Health Research Institute · Not applicable, Interventional, and Prevention
PRINCE is an international, multicentre, randomized controlled trial of posterior pericardiotomy in patients without a history of atrial fibrillation (AF) or flutter undergoing cardiac surgery.
Approximately 30% of cardiac surgical patients develop post-operative atrial fibrillation (POAF). Its incidence varies depending on the type of cardiac operation. POAF is associated with short- and long-term adverse events, including mortality, stroke, and heart failure. POAF has also been significantly associated with unplanned hospitalization for heart failure.
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 30 days, evaluated over the duration of follow-up.
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).
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 1,400 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Population Health Research Institute is the lead sponsor of 115 studies on the registry; 26 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 21, 2026. See what changed
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 a left posterior pericardiotomy during the patient's cardiac surgery.
Procedure: Left Posterior Pericardiotomy
The surgeon will not perform a posterior pericardiotomy during the patient's cardiac surgery.
The surgeon will perform a left posterior pericardiotomy while the patient is on cardiopulmonary bypass. A soft channel drain will be put into place at an angle directed toward the posterior pericardium. The surgeon will grasp the pericardium and use cautery to make a 4- to 5-cm opening between the left inferior pulmonary vein and the diaphragm. The previously prepared channel drain is cut to the desired length and placed through the pericardiotomy along the diaphragm and into the pleural space.
In-hospital post-operative atrial fibrillation
Number of patients with post-operative atrial fibrillation within the first 5 days postoperatively or up to hospital discharge, whichever occurs first
Time frame: Within 5 days after index cardiac surgery
Hierarchical composite of all-cause death, ischemic stroke, systemic arterial embolism, unplanned hospital visit/readmission for cardiac reasons, and atrial fibrillation.
Number of patients with a 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 30 days, evaluated using the win ratio (thereby accounting for the difference in importance of these outcomes).
Time frame: Over the duration of the follow-up period to a common end date (mean follow-up of 5 years).
Post-operative atrial fibrillation (POAF)
Number of patients with post-operative atrial fibrillation
Time frame: From index surgery completion to within 30 days of index surgery
Length of post-operative in-hospital stay
Length of time the patient in hospital after their index cardiac surgery
Time frame: Over the duration of the follow-up period to a common end date (mean follow-up of 5 years).
Pericardial effusion without tamponade
Number of pericardial effusions that occur, excluding cardiac tamponade
Time frame: From index surgery completion to within 30 days of index surgery
Death
Occurrence of death
Time frame: From index surgery completion to within 30 days of index surgery
Ischemic stroke or systemic arterial embolism
Number of ischemic strokes or systemic arterial embolisms
Time frame: From index surgery completion to within 30 days of index surgery
Hospital readmission or unplanned hospital visit
Number of hospital readmissions or unplanned hospital visits
Time frame: From index surgery completion to within 30 days of index surgery
Quality of life assessed by the European quality of life index version 5D (EQ-5D-5L) questionnaire
The EQ-5D-5L consists of a descriptive system and the EQ visual analogue scale (EQ VAS) scale of 0-100 where the endpoints are labelled 'The best health you can image' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is measured on a 5 point scale: no problems, slight problems, moderate problems, severe problems and extreme problems.
Time frame: Over the duration of the follow-up (mean follow-up of 5 years)
Functional abilities assessed by the SAGE (Standard Assessment of Global-Activities in the Elderly) questionnaire
Functional ability will be assessed using the SAGE questionnaire, which evaluates participants' ability to perform activities in their home and community over the previous month. The questionnaire assesses cognitive and functional activities, including attention, memory, concentration, managing finances and medications, meal preparation, transportation, mobility, dressing, transfers, and bathing/toileting. Difficulty with applicable activities is classified as none, mild, moderate, or severe. Mild difficulty is defined as minimal or occasional difficulty that does not affect the ability to perform the activity; moderate difficulty is regular difficulty that affects the ability to perform the activity, although the participant may still be able to perform it; and severe difficulty is extreme or constant difficulty, or inability to complete the activity or completion by another person because of the difficulty.
Time frame: Over the duration of the follow-up (mean follow-up of 5 years)
Number of patients with left phrenic nerve injuries
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 esophageal 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
Number of patients with cardiac tamponade
Safety outcome
Time frame: Within 30 days of index surgery
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Population Health Research Institute →