Status:
RECRUITING
Pericardiotomy in Cardiac Surgery
Lead Sponsor:
Population Health Research Institute
Collaborating Sponsors:
McMaster University
Hamilton Health Sciences Corporation
Conditions:
Atrial Fibrillation
Atrial Flutter
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
Approximately 30% of cardiac surgical patients develop post-operative atrial fibrillation (POAF). Its incidence varies depending on the type of cardiac operation. POAF is associated with short- and lo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2031
Estimated Enrollment :
1400 Patients enrolled
Trial Details
Trial ID
NCT06486636
Start Date
October 21 2024
End Date
September 1 2031
Last Update
July 14 2025
Active Locations (4)
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1
Weill Cornell Medicine
New York, New York, United States, 10065
2
Medical University Vienna
Vienna, Vienna, Austria, 1090
3
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2
4
University of Foggia, Policlinico Foggia
Foggia, Foggia, Italy, 71122