Pericardiotomy in Cardiac Surgery
Recruiting · NCT06486636 · Interventional (participants receive a specific treatment) · Lead sponsor: Population Health Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
Left Posterior Pericardiotomy
What this trial is about
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 can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
4 locations listed across 1 US state.
- Weill Cornell Medicine - New York, New York, United States
- University of Foggia, Policlinico Foggia - Foggia, Foggia, Italy
- Hamilton Health Sciences - Hamilton, Ontario, Canada
- Medical University Vienna - Vienna, State of Vienna, Austria