Prevention of Atrial Fibrillation After Cardiac Surgery by Pericardiotomy

NCT06728826 | Recruiting DMC

• 1 other identifier: CHEC2025-290
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation (AF); Cardiac Events; Pericardial Effusion

Keywords

Pericardiotomy; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Postoperative atrial fibrillation

  Number of patients with postoperative atrial fibrillation within the 30 days postoperatively

  Within 30 days after index cardiac surgery

Secondary Outcomes (8)

• Atrial fibrillation burden

  Within 30 days after index cardiac surgery

• Heart rate variability

  within 30 days of index surgery

• Antiarrhythmic drug use

  within 30 days of index surgery

• Electrical cardioversion

  within 30 days of index surgery

• Length of stay in ICU

  within 30 days of index surgery

Other Outcomes (6)

• Number of patients with cardiac tamponade

  Within 30 days of index surgery

• Number of patients with left pleural interventions

  Within 30 days of index surgery

• Number of patients with phrenic nerve injuries

  Within 30 days of index surgery

Study Arms (2)

Pericardiotomy Group

EXPERIMENTAL

The surgeon will perform posterior pericardiotomy during the cardiac surgery.

Procedure: Posterior pericardiotomy

Control Group

NO INTERVENTION

The surgeon will not perform posterior pericardiotomy during the cardiac surgery.

Interventions

Posterior pericardiotomy PROCEDURE

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.

Pericardiotomy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhai Hospital: lead
• The General Hospital of Northern Theater Command: collaborator

Study Sites (1)

Changhai Hospital

Shanghai, 200433, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Cardiovascular Diseases; Pericardial Effusion

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  STUDY DIRECTOR

• Hao Zhang, M.D. Ph.D.

  Naval Medical University Changhai Hospital

  PRINCIPAL INVESTIGATOR

• Yuji Zhang, M.D. Ph.D.

  The General Hospital of Northern Theater Command

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Zhang, M.D. Ph.D.

CONTACT

86-21-31161765; 13818178916@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each patient will be assigned in a blinded fashion to one of two groups (pericardiotomy or no pericardiotomy) in a 1:1 ratio.

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 11, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 14, 2026

Record last verified: 2025-09

Locations

CN (1)