Pericardiotomy in Cardiac Surgery
Purpose
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.
Conditions
- Atrial Fibrillation
- Atrial Flutter
- Cardiac Events
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Patients greater than or equal to 18 years of age - Requiring surgical intervention on the proximal aorta, cardiac valves, and/or coronary arteries - Able to provide informed consent
Exclusion Criteria
- History of atrial fibrillation or flutter - Cardiac surgery procedures not included in the inclusion criteria (planned ventricular assistance device, aortic arch, transplantation surgery) - Prior cardiac surgery requiring opening of the pericardium - Previous surgical instrumentation of the left pleural cavity - Patient undergoing minimally invasive cardiac surgery
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Each patient will be assigned in a blinded fashion to one of two groups (left posterior pericardiotomy or no posterior pericardiotomy) in a 1:1 ratio.
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Blinding to allocation will be maintained for all parties, excluding the operating surgeon and necessary operating room personnel.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Left Posterior Pericardiotomy Group |
The surgeon will perform a left posterior pericardiotomy during the patient's cardiac surgery. |
|
|
No Intervention No Posterior Pericardiotomy Group |
The surgeon will not perform a posterior pericardiotomy during the patient's cardiac surgery. |
|
Recruiting Locations
New York, New York 10065
More Details
- NCT ID
- NCT06486636
- Status
- Recruiting
- Sponsor
- Population Health Research Institute
Detailed Description
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 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).