Pericardiotomy for Cardiovascular Disease

(PRINCE Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Björn Redfors

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Population Health Research Institute

Disqualifiers: Atrial fibrillation, Prior cardiac surgery, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Left Posterior Pericardiotomy for cardiovascular disease?

Research shows that the treatment, Left Posterior Pericardiotomy, is effective in reducing the risk of atrial fibrillation (a type of irregular heartbeat) after heart surgery by allowing better drainage of fluids that can irritate the heart. ^{1 2 3 4 5}

Is posterior pericardiotomy generally safe for humans?

Posterior pericardiotomy has been studied in the context of heart surgery and is associated with a reduction in atrial fibrillation (irregular heartbeat) and pericardial effusion (fluid around the heart) after surgery, suggesting it is generally safe when performed in this setting. ^{1 3 4 5 6}

How is the treatment Left Posterior Pericardiotomy different from other treatments for cardiovascular disease?

Left Posterior Pericardiotomy is unique because it involves a surgical incision to allow drainage of blood and fluid, reducing irritation to the heart and preventing atrial fibrillation after cardiac surgery, unlike other treatments that may not address this specific cause. ^{1 3 4 5 7}

Research Team

Richard Whitlock

Principal Investigator

Population Health Research Institute

Mario Gaudino

Principal Investigator

Weill Medical College of Cornell University

Emilie Belley-Côté

Principal Investigator

Population Health Research Institute

Sigrid Sandner, MD

Principal Investigator

Medical University Vienna

Björn Redfors

Principal Investigator

Göteborg University

Eligibility Criteria

This trial is for adults over 18 who need heart surgery on the aorta, valves, or coronary arteries and can give informed consent. It's not for those with a history of atrial fibrillation or flutter.

Inclusion Criteria

I am 18 years old or older.

I am capable of understanding and agreeing to the trial's terms.

I need surgery on my heart or the main blood vessel coming from it.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cardiac surgery with or without left posterior pericardiotomy

Immediate post-surgery period

In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Follow-up visits at 1 month, 6 months, and every 6 months thereafter

Post-operative Monitoring

Monitoring for post-operative atrial fibrillation and other safety outcomes

30 days

Treatment Details

Interventions

• Left Posterior Pericardiotomy (Procedure)

Trial Overview The PRINCE trial is testing if doing a left posterior pericardiotomy during cardiac surgery can prevent complications like atrial fibrillation. Patients are randomly chosen to either get this procedure or not.

Participant Groups

Group I: Left Posterior Pericardiotomy Group Experimental Treatment 1 Intervention

The surgeon will perform a left posterior pericardiotomy during the patient's cardiac surgery.

Group II: No Posterior Pericardiotomy Group Active Control 1 Intervention

The surgeon will not perform a posterior pericardiotomy during the patient's cardiac surgery.

Left Posterior Pericardiotomy is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Posterior Left Pericardiotomy for:

• Prevention of postoperative atrial fibrillation after cardiac surgery

🇪🇺 Approved in European Union as Posterior Left Pericardiotomy for:

• Prevention of postoperative atrial fibrillation after cardiac surgery

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Weill Cornell Medicine New York, NY

Hamilton Health Sciences Hamilton, Canada

Who Is Running the Clinical Trial?

Population Health Research Institute

Lead Sponsor

Trials

165

Patients Recruited

717,000+

McMaster University

Collaborator

Trials

936

Patients Recruited

2,630,000+

Hamilton Health Sciences Corporation

Collaborator

Trials

380

Patients Recruited

345,000+

Weill Medical College of Cornell University

Collaborator

Trials

1103

Patients Recruited

1,157,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Meta-analysis of randomized trials on the efficacy of posterior pericardiotomy in preventing atrial fibrillation after coronary artery bypass surgery. [2022] Posterior pericardiotomy is considered a method to reduce the incidence of atrial fibrillation after cardiac surgery. Its efficacy in preventing atrial fibrillation and supraventricular arrhythmias after coronary artery bypass surgery has been evaluated in the present meta-analysis.

2. United States pubmed.ncbi.nlm.nih.gov

Effects of posterior pericardiotomy on the incidence of pericardial effusion and atrial fibrillation after coronary revascularization. [2006] The aim of this prospective, randomized study was to assess the efficacy of posterior pericardiotomy in decreasing the prevalence of pericardial effusion and postoperative atrial fibrillation (AF).

3. England pubmed.ncbi.nlm.nih.gov

Posterior left pericardiotomy for the prevention of atrial fibrillation after cardiac surgery. [2021] The posterior left pericardiotomy is a surgical procedure for the prevention of postoperative atrial fibrillation after cardiac surgery. It comprises a 4- to 5-cm longitudinal incision parallel and posterior to the phrenic nerve, extending from the left inferior pulmonary vein to the diaphragm. The pericardiotomy allows for prolonged drainage of dependent blood and pericardial fluid into the left pleural space, which is thought to be irritating to the left atrium, leading to postoperative atrial fibrillation. In this brief video tutorial, we demonstrate our technique for performing a posterior pericardiotomy.

4. United States pubmed.ncbi.nlm.nih.gov

Postoperative pericardial effusion, pericardiotomy, and atrial fibrillation: An explanatory analysis of the PALACS trial. [2023] In the Posterior left pericardiotomy for the prevention of atrial fibrillation after cardiac surgery (PALACS) trial, posterior pericardiotomy was associated with a significant reduction in postoperative atrial fibrillation (POAF) after cardiac surgery. We aimed to investigate the mechanisms underlying this effect.

5. United States pubmed.ncbi.nlm.nih.gov

Effect of posterior pericardiotomy on postoperative supraventricular arrhythmias and late pericardial effusion (posterior pericardiotomy). [2019] The aim of this prospective study was to evaluate the effectiveness of posterior pericardiotomy from the point of pericardial effusion related with supraventricular tachycardia and development of delayed posterior cardiac effusions.

6. Germany pubmed.ncbi.nlm.nih.gov

Posterior pericardiotomy reduces the incidence of supra-ventricular arrhythmias and pericardial effusion after coronary artery bypass grafting. [2019] The aim of this prospective study was to demonstrate the effectiveness of posterior pericardiotomy in reducing the incidence pericardial effusions and consequently reducing the related supraventricular tachyarrhythmias and development of delayed posterior cardiac effusions.

7. England pubmed.ncbi.nlm.nih.gov

Posterior pericardial window: a simple and reproducible technique in order to prevent pericardial tamponade in paediatric cardiac surgery. [2023] Pericardial tamponade, which increases postoperative mortality and morbidity, is still not uncommon after paediatric cardiac surgery. We considered that posterior pericardiotomy may be a useful and safe technique in order to reduce the incidence of early and late pericardial tamponade. Herein, we present our experience with creation of posterior pericardial window following congenital cardiac surgical procedures.