Atrial Fibrillation (AF)PRINCE-CHNCT06728826
Prevention of Atrial Fibrillation After Cardiac Surgery by Pericardiotomy
A study testing Posterior pericardiotomy in people with Atrial Fibrillation (AF) and Cardiac Events, run by Changhai Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Cardiac Events, Pericardial Effusion
- What is being tested?
- Posterior pericardiotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, 200433
Fan Yang, M.D. Ph.D., 86-21-31161765, 13818178916@163.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Posterior pericardiotomy
- Keywords
- Pericardiotomy, Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation, Cardiovascular Diseases, Pericardial Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior pericardiotomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Pericardiotomy Group | Experimental | The surgeon will perform posterior pericardiotomy during the cardiac surgery. Receives: Procedure: Posterior pericardiotomy |
| Control Group | No intervention | The surgeon will not perform posterior pericardiotomy during the cardiac surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative atrial fibrillation
Number of patients with postoperative atrial fibrillation within the 30 days postoperatively
Measured: Within 30 days after index cardiac surgery
Secondary outcomes (8)
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.
Measured: Within 30 days after index cardiac surgery
Heart rate variability
Average HR(bpm), Highest HR(bpm), Lowest HR(bpm), pNN50(%), rMSSD(ms), SDNN(ms)
Measured: within 30 days of index surgery
Antiarrhythmic drug use
Number of patients received antiarrhythmic drug to control heart rhythm
Measured: within 30 days of index surgery
Electrical cardioversion
Number of patients received electrical cardioversion for severe heart arrhythmia
Measured: within 30 days of index surgery
Length of stay in ICU
Length of time in ICU
Measured: within 30 days of index surgery
Duration of hospitalization
Duration of hospitalization
Measured: within 30 days of index surgery
Hospital readmission or unplanned hospital visit
Number of hospital readmissions or unplanned hospital visits
Measured: 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
Measured: within 30 days of index surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each patient will be assigned in a blinded fashion to one of two groups (pericardiotomy or no pericardiotomy) in a 1:1 ratio.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The General Hospital of Northern Theater Command
- Responsible party
- Sponsor
- Investigators
- Lin Han, M.D. Ph.D., Study director, Naval Medical University Changhai HospitalHuishan Wang, M.D. Ph.D., Study director, The General Hospital of Northern Theater CommandHao Zhang, M.D. Ph.D., Principal investigator, Naval Medical University Changhai HospitalYuji Zhang, M.D. Ph.D., Principal investigator, The General Hospital of Northern Theater Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728826
- Sponsor's protocol ID
- CHEC2025-290
- Acronym
- PRINCE-CH
- Status last verified
- Sep 2025
- First submitted
- 8 Dec 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pericardiotomy for Prevention of Postoperative Atrial Fibrillation After Cardiac Surgery in China
- ClinicalTrials.gov ID
- NCT06728826
- Acronym / sponsor ID
- PRINCE-CH / CHEC2025-290
- Keywords
- Pericardiotomy, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- The General Hospital of Northern Theater Command
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Each patient will be assigned in a blinded fashion to one of two groups (pericardiotomy or no pericardiotomy) in a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Pericardiotomy Group | Experimental | Procedure: Posterior pericardiotomyThe surgeon will perform posterior pericardiotomy during the cardiac surgery. |
| Control Group | No intervention | –The surgeon will not perform posterior pericardiotomy during the cardiac surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterior pericardiotomyThe 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. | Procedure or surgery | Pericardiotomy Group |
Primary outcome
Postoperative atrial fibrillation
Time frame: Within 30 days after index cardiac surgery
Number of patients with postoperative atrial fibrillation within the 30 days postoperatively
8 secondary outcomes
Atrial fibrillation burden
Time frame: Within 30 days after index cardiac surgery
Heart rate variability
Time frame: within 30 days of index surgery
Antiarrhythmic drug use
Time frame: within 30 days of index surgery
Electrical cardioversion
Time frame: within 30 days of index surgery
Length of stay in ICU
Time frame: within 30 days of index surgery
Duration of hospitalization
Time frame: within 30 days of index surgery
Hospital readmission or unplanned hospital visit
Time frame: within 30 days of index surgery
Change in Quality of life
Time frame: within 30 days of index surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lin Han, M.D. Ph.D. study director
Naval Medical University Changhai Hospital
Huishan Wang, M.D. Ph.D. study director
The General Hospital of Northern Theater Command
Hao Zhang, M.D. Ph.D. principal investigator
Naval Medical University Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior pericardiotomy in people with Atrial Fibrillation (AF) and Cardiac Events, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hao Zhang, M.D. Ph.D. (86-21-31161765, 13818178916@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative atrial fibrillation (time frame: Within 30 days after index cardiac surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.