Pericardiotomy in Cardiac Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPopulation Health Research Institute
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Left Posterior Pericardiotomy
Treatment groups
1,400 Participants
are divided into 2 treatment groupsSponsors and collaborators
Population Health Research Institute
Lead sponsor
McMaster University
Collaborator
Hamilton Health Sciences Corporation
Collaborator
Weill Medical College of Cornell University
Collaborator
Source ClinicalTrials.gov