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NCT Number: NCT06728826

Prevention of Atrial Fibrillation After Cardiac Surgery by Pericardiotomy

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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiac Events Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pericardial Effusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Postoperative atrial fibrillation

    Time frame: Within 30 days after index cardiac surgery

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

Secondary outcomes

  1. Atrial fibrillation burden

    Time frame: Within 30 days after index cardiac surgery

    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.

  2. Heart rate variability

    Time frame: within 30 days of index surgery

    Average HR(bpm), Highest HR(bpm), Lowest HR(bpm), pNN50(%), rMSSD(ms), SDNN(ms)

  3. Antiarrhythmic drug use

    Time frame: within 30 days of index surgery

    Number of patients received antiarrhythmic drug to control heart rhythm

  4. Electrical cardioversion

    Time frame: within 30 days of index surgery

    Number of patients received electrical cardioversion for severe heart arrhythmia

  5. Length of stay in ICU

    Time frame: within 30 days of index surgery

    Length of time in ICU

  6. Duration of hospitalization

    Time frame: within 30 days of index surgery

    Duration of hospitalization

  7. Hospital readmission or unplanned hospital visit

    Time frame: within 30 days of index surgery

    Number of hospital readmissions or unplanned hospital visits

  8. Change in Quality of life

    Time frame: within 30 days of index surgery

    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

Other outcomes

  1. Number of patients with cardiac tamponade

    Time frame: Within 30 days of index surgery

    Safety outcome

  2. Number of patients with left pleural interventions

    Time frame: Within 30 days of index surgery

    Safety outcome

  3. Number of patients with phrenic nerve injuries

    Time frame: Within 30 days of index surgery

    Safety outcome

  4. Number of patients requiring re-operation for bleeding

    Time frame: Within 48 hours of index surgery completion

    Safety outcome

  5. Ischemic stroke

    Time frame: within 30 days of index surgery

    Safety outcome

  6. Death

    Time frame: within 30 days of index surgery

    Safety outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Hao Zhang, M.D. Ph.D.

CONTACT

[email protected]

86-21-31161765

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

  • The General Hospital of Northern Theater Command

Registry information

Official study title

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

Acronym: PRINCE-CH

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 11, 2024
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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