Surgical procedure to prevent heart rhythm issues after cardiac surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The PRINCE trial is an international, multicentre, randomized controlled trial investigating the effectiveness of posterior left pericardiotomy in patients undergoing cardiac surgery who do not have a history of atrial fibrillation or flutter. This procedure aims to reduce the incidence of post-operative atrial fibrillation (POAF), which is associated with significant adverse outcomes such as mortality and heart failure. By allowing for prolonged drainage of pericardial fluid, the trial seeks to determine if this intervention can improve long-term clinical outcomes for patients after surgery. The study will follow participants over time to assess the impact of the procedure on hospital readmissions and overall health.

Why it matters

Who can join: the full rules

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, planned 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's running

• University of Louisville
  Louisville, Kentucky, United States Recruiting
• Baylor College of Medicine
  Houston, Texas, United States Recruiting
• Medical University Vienna
  Vienna, State of Vienna, Austria Recruiting
• Medical University of Innsbruck
  Innsbruck, Tyrol, Austria Recruiting
• Nova Scotia Health Authority - Halifax Infirmary
  Halifax, Nova Scotia, Canada Recruiting
• St. Michael's Hospital
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Richard Whitlock — Population Health Research Institute
• Study coordinator: Richard Whitlock
• Email: Richard.Whitlock@phri.ca
• Phone: 9055274322

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Monitoring heart rhythm after noncardiac surgery

  This study is testing if wearing a portable heart monitor for up to 14 days after noncardiac surgery can help find heart rhythm problems that are often missed, to improve care for patients.

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• Registry for Atrial Fibrillation Care Guidelines

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• Long-term outcomes for patients with cardiac arrhythmias

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  Recruiting Universitätsklinikum Hamburg-Eppendorf · Hamburg · NCT05521451

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.