RecruitingNot ApplicableNCT06486636

Pericardiotomy in Cardiac Surgery

Pericardiotomy in Cardiac Surgery Trial

Sponsor

Population Health Research Institute

Enrollment

1,400 participants

Start Date

Oct 21, 2024

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation Atrial Flutter Cardiac Events

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is investigating whether a specific surgical technique — opening or not opening the sac around the heart (the pericardium) in a particular way during heart surgery — affects the rate of irregular heartbeats (atrial fibrillation) after surgery. **You may be eligible if...** - You are 18 or older - You are scheduled for surgery on the main artery from the heart (proximal aorta), heart valves, or coronary arteries - You are able to provide informed consent **You may NOT be eligible if...** - You have a history of atrial fibrillation or atrial flutter - You are having a different type of heart surgery (e.g., ventricular device, aortic arch, heart transplant) - You have had prior open-heart surgery - You have had previous surgery on the left side of your chest cavity - You are having minimally invasive (keyhole) heart surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELeft Posterior Pericardiotomy

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.