Prevention of Atrial Fibrillation After Cardiac Surgery by Pericardiotomy (PRINCE-CH)

Pericardiotomy for Prevention of Postoperative Atrial Fibrillation After Cardiac Surgery in China

PRINCE-CH is a multicentre, randomized controlled trial which evaluates the effectiveness and safety of posterior pericardiotomy in preventing POAF after cardiac surgery in Chinese population.

Study Overview

• Status: Recruiting
• Conditions: Pericardial Effusion; Atrial Fibrillation (AF); Cardiac Events
• Intervention / Treatment: Procedure: Posterior pericardiotomy

Detailed Description

Postoperative atrial fibrillation (POAF), defined as new-onset atrial fibrillation (AF) in the immediate period after surgery, is the most important type of secondary AF, which complicates 20-40% patients receiving cardiac surgery.

POAF is associated with haemodynamic instability , increased risk of stroke, lengthened hospital and intensive care unit stays and greater costs.

Pericardial effusion accumulated posterior to the left atrium after cardiac surgery could trigger atrial arrhythmias. Pericardiotomy allows for prolonged drainage of the pericardial effusion into left pleural space. Recent research evidence found that pericardiotomy was associated with a significantly lower incidence of POAF. The existing data on posterior pericardiotomy is promising for a reduction in POAF. The PRINCE trial's long-term follow-up of patients randomized to pericardiotomy could conclusively demonstrate whether the relationship of POAF to post-discharge clinical outcomes is causal and modifiable.

The PRINCE-CH trial will evaluate the effectiveness and safety of pericardiotomy in preventing POAF after cardiac surgery in Chinese population.

The intervention is posterior pericardiotomy and the control is no posterior pericardiotomy during cardiac surgery. The primary outcome is the occurrence of POAF.

The study will enrol 650 patients from 15 centres in China. All participants will be continuously monitored using a wearable body surface electrocardiogram (EKG) monitoring equipment from the day of surgery to 30 days after surgery.

• Study Type: Interventional
• Enrollment (Estimated): 650
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hao Zhang, M.D. Ph.D.; Phone Number: 86-21-31161765; Email: 13818178916@163.com

Study Locations

• China
  • Shanghai, China, 200433
    • Recruiting
    • Changhai Hospital
    • Contact: Fan Yang, M.D. Ph.D.; Phone Number: 86-21-31161765; Email: 13818178916@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients older than or equal to 18 years of age
• Requiring surgical intervention on proximal aorta, cardiac valves, and/or coronary arteries
• Able to provide informed consent

Exclusion Criteria:

• History of atrial fibrillation or flutter
• Reoperations/minimally invasive cardiac surgery/emergent presentation
• Need for hypothermic circulatory arrest
• Disease of the left pleura or previous left thoracotomy
• Chest deformity
• Unlikely to participate in follow-up assessments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pericardiotomy Group; The surgeon will perform posterior pericardiotomy during the cardiac surgery.	Procedure: Posterior pericardiotomy; The surgeon will perform a posterior pericardiotomy while the patient is on cardiopulmonary bypass. In detail, a 4-cm opening in the posterior pericardium will be made with a cautery between the left inferior pulmonary vein and the diaphragm. Then a soft channel drain will be placed through the opening in pericardium with the tip into the left pleural space.
No Intervention: Control Group; The surgeon will not perform posterior pericardiotomy during the cardiac surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative atrial fibrillation	Number of patients with postoperative atrial fibrillation within the 30 days postoperatively	Within 30 days after index cardiac surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial fibrillation burden	The proportion of time spent in atrial fibrillation during the total time of cardiac rhythm monitoring within 30 days after the operation, expressed as a percentage.	Within 30 days after index cardiac surgery
Heart rate variability	Average HR(bpm), Highest HR(bpm), Lowest HR(bpm), pNN50(%), rMSSD(ms), SDNN(ms)	within 30 days of index surgery
Antiarrhythmic drug use	Number of patients received antiarrhythmic drug to control heart rhythm	within 30 days of index surgery
Electrical cardioversion	Number of patients received electrical cardioversion for severe heart arrhythmia	within 30 days of index surgery
Length of stay in ICU	Length of time in ICU	within 30 days of index surgery
Duration of hospitalization	Duration of hospitalization	within 30 days of index surgery
Hospital readmission or unplanned hospital visit	Number of hospital readmissions or unplanned hospital visits	within 30 days of index surgery
Change in Quality of life	Change in Quality of life assessed by the European quality of life index version 5D (EQ-5D-5L) questionnaire from baseline to 30 days after surgery	within 30 days of index surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with phrenic nerve injuries	Safety outcome	Within 30 days of index surgery
Number of patients with left pleural interventions	Safety outcome	Within 30 days of index surgery
Number of patients requiring re-operation for bleeding	Safety outcome	Within 48 hours of index surgery completion
Number of patients with cardiac tamponade	Safety outcome	Within 30 days of index surgery
Ischemic stroke	Safety outcome	within 30 days of index surgery
Death	Safety outcome	within 30 days of index surgery

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: The General Hospital of Northern Theater Command
• Investigators: Principal Investigator: Hao Zhang, M.D. Ph.D., Naval Medical University Changhai Hospital; Study Director: Lin Han, M.D. Ph.D., Naval Medical University Changhai Hospital; Study Director: Huishan Wang, M.D. Ph.D., The General Hospital of Northern Theater Command; Principal Investigator: Yuji Zhang, M.D. Ph.D., The General Hospital of Northern Theater Command

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: December 8, 2024
• First Submitted That Met QC Criteria: December 8, 2024
• First Posted (Actual): December 11, 2024

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 12, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Pericardiotomy
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases; Atrial Fibrillation; Pericardial Effusion
• Other Study ID Numbers: CHEC2025-290

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No