PROlonged posterior PERicardial chest tube treatment to reduce rates of postoperative atrial fibrillation following cardiac surgery (PROPER trial): Rationale and design of a prospective, multinational, randomized clinical trial

Postoperative atrial fibrillation (POAF) is the most common complication after cardiac surgery and is associated with increased morbidity and prolonged hospitalization. Accumulation of pericardial blood after surgery triggers a localized inflammatory response that has been identified as a contributing factor in POAF development. The PROPER trial (ClinicalTrials.gov Identifier: NCT06800781) is a prospective, multinational, randomized, controlled clinical trial designed to determine whether evacuation of pericardial blood through prolonged drainage using a posterior pericardial chest tube reduces the incidence of POAF following elective cardiac surgery. In addition to routine surveillance, patients will be monitored using a wearable electrocardiographic patch monitor. Patients undergoing non-emergent, first-time coronary bypass grafting, aortic valve replacement, aortic surgery without circulatory arrest, or a combination of these procedures, are randomized 1:1 to either receive intraoperative placement of a posterior pericardial chest tube or standard care. A total of 624 patients will be enrolled across eight Nordic cardiac surgery centers. The primary endpoint is atrial fibrillation (AF) recorded within seven days after surgery. Secondary endpoints include AF recurrence, hospitalization due to bleeding or ischemic stroke, and all-cause mortality. Patients will be followed for five years. If effective, posterior pericardial drainage represents a readily available, low-risk strategy with the potential for rapid and broad adoption in clinical practice.