Pericardiotomy in Cardiac Surgery
Launched by POPULATION HEALTH RESEARCH INSTITUTE · Jun 27, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The PRINCE trial is a study looking at a specific surgical technique called posterior pericardiotomy, which is performed during cardiac surgery. This trial is aimed at understanding whether this technique can help patients who do not have a history of atrial fibrillation (AF) or atrial flutter—conditions that affect the heart's rhythm—when they are undergoing surgery on their heart or major blood vessels. The trial is open to adults aged 18 and older who need surgery on the aorta, heart valves, or coronary arteries and can give their consent.
If you or a family member are considering participating in this trial, it's important to know that you must not have had any previous episodes of atrial fibrillation or flutter, and certain types of heart surgeries are not included. Participants can expect to be part of a randomized controlled study, meaning they have a chance to receive either the standard care or the new surgical technique being studied. This research is being conducted at multiple centers, and it aims to find out if the new approach can improve outcomes for patients undergoing cardiac surgery.
Gender
ALL
Eligibility criteria
- 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
About Population Health Research Institute
The Population Health Research Institute (PHRI) is a leading clinical research organization dedicated to advancing the understanding of population health through innovative research methodologies. With a focus on large-scale, multi-center clinical trials and epidemiological studies, PHRI aims to address pressing health challenges by investigating the interplay between lifestyle, genetic, and environmental factors. By fostering collaboration among researchers, healthcare providers, and communities, PHRI strives to generate evidence-based insights that inform public health policies and improve health outcomes on a global scale. Their commitment to excellence in research is underscored by a robust infrastructure and a multidisciplinary team of experts dedicated to translating research findings into actionable solutions for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Vienna, , Austria
Hamilton, Ontario, Canada
New York, New York, United States
Patients applied
Trial Officials
Richard Whitlock
Principal Investigator
Population Health Research Institute
Emilie Belley-Côté
Principal Investigator
Population Health Research Institute
Mario Gaudino
Principal Investigator
Weill Medical College of Cornell University
Sigrid Sandner
Principal Investigator
Medical University Vienna
Björn Redfors
Principal Investigator
Göteborg University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported