Pericardiotomy for Cardiovascular Disease

(PRINCE Trial)

Recruiting at 2 trial locations

Overseen By PRINCE Coordinators

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Population Health Research Institute

Disqualifiers: Atrial fibrillation, Prior cardiac surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-surgery period

1400 Participants Needed

Trial Summary

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}

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.

Research Team

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

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

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

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

Who Is Running the Clinical Trial?

Population Health Research Institute

Lead Sponsor

Trials

165

Recruited

717,000+

McMaster University

Collaborator

Trials

936

Recruited

2,630,000+

Hamilton Health Sciences Corporation

Collaborator

Trials

380

Recruited

345,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Findings from Research

Posterior pericardiotomy significantly reduces the incidence of postoperative atrial fibrillation (10.8% in the PP group vs. 28.1% in the control group) and supraventricular arrhythmias after coronary artery bypass surgery, based on a meta-analysis of 763 patients from 6 randomized studies.

The procedure also leads to a marked reduction in postoperative pericardial effusion, which is suggested to be a key factor in the development of atrial fibrillation after cardiac surgery.

NCBI (Pubmed)

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. Biancari, F., Mahar, MA.[2022]

In a study of 100 patients undergoing coronary artery bypass grafting, those who received posterior pericardiotomy had a significantly lower incidence of early pericardial effusion (12%) compared to those who did not undergo the procedure (42%).

The procedure also reduced the occurrence of postoperative atrial fibrillation, with only 10% of patients in the pericardiotomy group developing AF compared to 30% in the control group, indicating its efficacy in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of posterior pericardiotomy on the incidence of pericardial effusion and atrial fibrillation after coronary revascularization. Ekim, H., Kutay, V., Hazar, A., et al.[2006]

The posterior left pericardiotomy is a surgical technique designed to prevent postoperative atrial fibrillation in patients undergoing cardiac surgery by allowing for effective drainage of blood and fluid.

This procedure involves a specific incision near the phrenic nerve and is believed to reduce irritation to the left atrium, which is a contributing factor to the development of atrial fibrillation after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posterior left pericardiotomy for the prevention of atrial fibrillation after cardiac surgery. Lau, C., Soletti, GJ., Olaria, RP., et al.[2021]

In the PALACS trial involving 387 patients, posterior pericardiotomy significantly reduced the incidence of postero-lateral pericardial effusion (37% vs 67%), which is linked to a lower risk of postoperative atrial fibrillation (POAF).

The study suggests that reducing postero-lateral pericardial effusion may be an effective strategy to prevent POAF after cardiac surgery, as left atrial size and function did not show significant changes post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative pericardial effusion, pericardiotomy, and atrial fibrillation: An explanatory analysis of the PALACS trial. Rong, LQ., Di Franco, A., Rahouma, M., et al.[2023]

In a study of 200 patients undergoing coronary artery bypass surgery, those who received posterior pericardiotomy (group I) had a significantly lower incidence of atrial fibrillation (6%) compared to those who did not undergo the procedure (group II, 34%).

Group I also experienced no cases of early or late pericardial effusion, while group II had 54% and 21% respectively, demonstrating that posterior pericardiotomy is an effective technique for preventing complications related to pericardial effusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of posterior pericardiotomy on postoperative supraventricular arrhythmias and late pericardial effusion (posterior pericardiotomy). Kuralay, E., Ozal, E., Demirkili, U., et al.[2019]

In a study of 150 patients undergoing coronary artery bypass grafting, posterior pericardiotomy significantly reduced the incidence of early pericardial effusion (10.6% in the pericardiotomy group vs. 42.6% in the control group) and related atrial fibrillation (9.3% vs. 32%, P<0.001).

The technique also prevented the development of late pericardial effusions, with no cases in the pericardiotomy group compared to 9.3% in the control group, highlighting its effectiveness in managing post-surgical complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posterior pericardiotomy reduces the incidence of supra-ventricular arrhythmias and pericardial effusion after coronary artery bypass grafting. Farsak, B., Günaydin, S., Tokmakoğlu, H., et al.[2019]

In a study of 229 pediatric patients who underwent cardiac surgery, the creation of a posterior pericardial window effectively prevented both early and late pericardial tamponade, a serious complication that can increase mortality and morbidity.

The technique was safe, with no instances of pericardial tamponade reported, and involved placing a curved chest tube to facilitate drainage, demonstrating its potential as a standard practice in pediatric cardiac surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posterior pericardial window: a simple and reproducible technique in order to prevent pericardial tamponade in paediatric cardiac surgery. Simsek, B., Ozyuksel, A., Saygi, M., et al.[2023]

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]

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]

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

Posterior left pericardiotomy for the prevention of atrial fibrillation after cardiac surgery. [2021]

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

Postoperative pericardial effusion, pericardiotomy, and atrial fibrillation: An explanatory analysis of the PALACS trial. [2023]

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

Effect of posterior pericardiotomy on postoperative supraventricular arrhythmias and late pericardial effusion (posterior pericardiotomy). [2019]

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]

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]