Pericardiotomy for Cardiovascular Disease

(PRINCE Trial)

Recruiting at 3 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a surgical technique called left posterior pericardiotomy to determine if it benefits patients needing heart surgery who have never experienced atrial fibrillation (an irregular heartbeat). The goal is to assess whether this procedure can improve outcomes for these patients. Participants will either receive the new technique during their surgery or not, allowing for a comparison of results. This trial suits those needing surgery on their heart valves, main artery (aorta), or coronary arteries and who have never had atrial fibrillation or previous major heart surgery. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance surgical outcomes.

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 prior data suggests that this technique is safe for cardiac surgery patients?

Research has shown that left posterior pericardiotomy is generally safe. This surgical method involves making a small cut in the sac around the heart. Studies have found it to be simple and well-tolerated by patients. In one study, only 1% of patients who underwent this procedure died within 30 days, a rate similar to those who did not have the procedure. This suggests that the treatment is unlikely to increase the risk of death shortly after surgery. Overall, it appears to be a safe option for those undergoing heart surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about left posterior pericardiotomy because it offers a novel approach to managing cardiovascular disease during cardiac surgery. Unlike traditional treatments that focus on medication or more invasive procedures, this technique involves a surgical incision in the pericardium, which is expected to reduce complications like pericardial effusion by allowing fluid to drain more effectively. This method could potentially enhance recovery and outcomes compared to the standard care, which typically doesn't involve this type of pericardial intervention. By directly addressing fluid buildup, left posterior pericardiotomy could represent a significant advancement in surgical care for heart patients.

What evidence suggests that left posterior pericardiotomy might be an effective treatment for cardiovascular disease?

Research has shown that posterior left pericardiotomy can effectively reduce certain complications after heart surgery. In this trial, participants in the Left Posterior Pericardiotomy Group will undergo this procedure during their cardiac surgery. Studies have found that it significantly lowers the risk of developing atrial fibrillation, an irregular heartbeat, after surgery. For example, one study showed a decrease from 32% to 17%. This technique also reduces the risk of fluid buildup around the heart, known as pericardial effusion, and the pressure from this fluid, called cardiac tamponade. Importantly, it provides these benefits without increasing the risk of death or other serious issues. The evidence strongly suggests that this surgical method can improve recovery after heart surgery. ^{1 2 3 5 6}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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 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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11953021/

Posterior left pericardiotomy: what is the advantage in ... Several studies support the hypothesis that PP decreases the incidence of POAF, pericardial effusion and cardiac tamponade after cardiac surgery ...

2. acc.org acc.org/Latest-in-Cardiology/Articles/2022/04/11/15/08/The-Role-of-the-Posterior-Left-Pericardiotomy-in-Reducing-Pericardial-Effusion

The Role of the Posterior Left Pericardiotomy in Reducing ... Our results showed that posterior pericardiotomy largely and significantly reduced the incidence of POAF (17% vs. 32%; p<0.001; OR 0.44, 95% CI ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06486636

NCT06486636 | Pericardiotomy in Cardiac Surgery The PRINCE trial will evaluate the effectiveness and safety of posterior left pericardiotomy in preventing POAF and improving post-discharge clinical outcomes ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0140673621024909

Posterior left pericardiotomy for the prevention of atrial ... Posterior left pericardiotomy is highly effective in reducing the incidence of atrial fibrillation after surgery on the coronary arteries, ...

5. jtcvsopen.org jtcvsopen.org/article/S2666-2736(24)00278-X/fulltext

Commentary: Is posterior pericardiotomy dangerous? Not ... According to current evidence, posterior left pericardiotomy is not associated with increased mortality and morbidity, and significantly decreases atrial ...

6. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2022.1090102/full

Effect of posterior pericardiotomy in cardiac surgery Conclusions: PP is a safe and effective intervention that significantly decreases the incidence of POAF and pericardial effusion following ...