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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Left Posterior Pericardiotomy
Procedure/SurgeryThe 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.
Treatment groups
1,400 Participants
are divided into 2 treatment groupsGroup A: Left Posterior Pericardiotomy GroupExperimental treatment 1 intervention
Group B: No Posterior Pericardiotomy GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
In-hospital post-operative atrial fibrillation
Number of patients with post-operative atrial fibrillation within the first 5 days postoperatively or up to hospital discharge, whichever occurs first
Time frame
Within 5 days after index cardiac surgery2
Hierarchical composite of all-cause death, ischemic stroke, systemic arterial embolism, unplanned hospital visit/readmission for cardiac reasons, and atrial fibrillation.
Number of patients with a composite of all-cause death, ischemic stroke, systemic arterial embolism, unplanned hospital visit/readmission for cardiac reasons, and atrial fibrillation events, evaluated using the win ratio (thereby accounting for the difference in importance of these outcomes).
Time frame
Over the duration of the follow-up period to a common end date (mean follow-up of 5 years).Secondary outcomes
1
Post-operative atrial fibrillation (POAF)
Number of patients with post-operative atrial fibrillation
Time frame
Over the duration of the follow-up period to a common end date (mean follow-up of 5 years).2
Length of post-operative in-hospital stay
Length of time the patient in hospital after their index cardiac surgery
Time frame
Over the duration of the follow-up period to a common end date (mean follow-up of 5 years).3
Pericardial effusion without tamponade
Number of pericardial effusions that occur, excluding cardiac tamponade
Time frame
From index surgery completion to within 30 days of index surgery4
Death
Occurrence of death
Time frame
From index surgery completion to within 30 days of index surgeryOther outcomes
1
Number of patients with phrenic nerve injuries
Safety outcome
Time frame
Within 30 days of index surgery2
Number of patients with left pleural interventions
Safety outcome
Time frame
Within 30 days of index surgery3
Number of patients with esophageal injuries
Safety outcome
Time frame
Within 30 days of index surgery4
Number of patients requiring re-operation for bleeding
Safety outcome
Time frame
Within 48 hours of index surgery completionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Population Health Research Institute
Lead sponsor
McMaster University
Collaborator
Hamilton Health Sciences Corporation
Collaborator
Weill Medical College of Cornell University
Collaborator
Source ClinicalTrials.gov