Surgical procedure to prevent heart rhythm issues after cardiac surgery
Pericardiotomy in Cardiac Surgery Trial
This study is testing a surgical procedure to see if it can help prevent heart rhythm problems after heart surgery for patients who haven't had these issues before.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Population Health Research Institute Academic / other |
| Locations | 4 sites (New York, New York and 3 other locations) |
| Trial ID | NCT06486636 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older requiring surgical intervention on the proximal aorta, cardiac valves, or coronary arteries without a history of atrial fibrillation or flutter.
Not a fit: Patients with a history of atrial fibrillation or flutter, or those undergoing specific cardiac procedures not included in the study, may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this procedure could significantly reduce the occurrence of post-operative atrial fibrillation and improve long-term health outcomes for cardiac surgery patients.
How similar studies have performed: Previous research has shown promising results for posterior pericardiotomy in reducing post-operative atrial fibrillation, but this trial aims to provide high-quality evidence on its impact on long-term clinical outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York and 3 other locations
- Weill Cornell Medicine — New York, New York, United States (Recruiting)
- Medical University Vienna — Vienna, State of Vienna, Austria (Recruiting)
- Hamilton Health Sciences — Hamilton, Ontario, Canada (Recruiting)
- University of Foggia, Policlinico Foggia — Foggia, Foggia, Italy (Recruiting)
Study contacts
- Principal investigator: Richard Whitlock — Population Health Research Institute
- Study coordinator: Richard Whitlock
- Email: Richard.Whitlock@phri.ca
- Phone: 9055274322
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.