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Search / Trial NCT06486636

Pericardiotomy in Cardiac Surgery

Launched by POPULATION HEALTH RESEARCH INSTITUTE · Jun 27, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Pericardiotomy Cardiac Surgery Hospital Readmission Post Operative Atrial Fibrillation

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.

Locations

Vienna, , Austria

Hamilton, Ontario, Canada

New York, New York, United States

Patients applied

0 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