Pericardiotomy in Cardiac Surgery
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.
| Condition(s) | Atrial Fibrillation, Atrial Flutter, Cardiac Events |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Population Health Research Institute |
| Locations | New York, New York, United States; Vienna, State of Vienna, Austria; Hamilton, Ontario, Canada; Foggia, Foggia, Italy |
| Start date | 2024-10-21 |
| NCT ID | NCT06486636 |
| Official listing | https://clinicaltrials.gov/study/NCT06486636 |