PRINCE

• Research type

  Research Study

• Full title

  Pericardiotomy in Cardiac Surgery Trial

• IRAS ID

  360824

• Contact name

  Prakash P Punjabi

• Contact email

  p.punjabi@imperial.ac.uk

• Sponsor organisation

  Population Health Research Institute

• Clinicaltrials.gov Identifier

  NCT06486636

• Duration of Study in the UK

  5 years, 0 months, 0 days

• Research summary

  Approximately 30% of patients that undergo heart surgery develop an abnormal heart rhythm after their surgery known as post-operative atrial fibrillation (POAF). POAF is associated with short- and long-term complications, including longer hospital stays, stroke, heart failure, and death. The PRINCE trial will evaluate the effectiveness and safety of a surgical intervention called "left posterior pericardiotomy" in preventing POAF and improving post-discharge clinical outcomes in a broad spectrum of heart surgery patients. Left posterior pericardiotomy involves making a 4-5 cm incision in the fluid-filled sac that surrounds the heart (the pericardium). This incision allows drainage of the
  pericardium into the left part of the chest during the post-operative period.

  Participants will be randomly assigned to either Group 1: no pericardiotomy or Group 2: left posterior pericardiotomy. The clinical outcomes that occur will then be compared between the two groups to assess whether patients that undergo left posterior pericardiotomy have better clinical outcomes and quality of life. The study will enroll 1400 patients, globally. Participants will be followed for an average of 5 years after their heart surgery to determine any complications they may have.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  25/SW/0103

• Date of REC Opinion

  14 Oct 2025

• REC opinion

  Further Information Favourable Opinion