RECRUITINGINTERVENTIONAL
Pericardiotomy in Cardiac Surgery
Pericardiotomy in Cardiac Surgery Trial
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
PROCEDURE
Left 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.
Locations (4)
Weill Cornell Medicine
New York, New York, United States
Medical University Vienna
Vienna, Vienna, Austria
Hamilton Health Sciences
Hamilton, Ontario, Canada
University of Foggia, Policlinico Foggia
Foggia, Foggia, Italy