Atrial Fibrillation (AF), Cardiac Events, Pericardial Effusion
Conditions
Keywords
Pericardiotomy, Atrial Fibrillation
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.
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.
Interventions
PROCEDUREPosterior 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.
Sponsors
Changhai Hospital
The General Hospital of Northern Theater Command
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative atrial fibrillation | Within 30 days after index cardiac surgery | Number of patients with postoperative atrial fibrillation within the 30 days postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Atrial fibrillation burden | 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. |
| Heart rate variability | within 30 days of index surgery | Average HR(bpm), Highest HR(bpm), Lowest HR(bpm), pNN50(%), rMSSD(ms), SDNN(ms) |
| Antiarrhythmic drug use | within 30 days of index surgery | Number of patients received antiarrhythmic drug to control heart rhythm |
| Electrical cardioversion | within 30 days of index surgery | Number of patients received electrical cardioversion for severe heart arrhythmia |
| Length of stay in ICU | within 30 days of index surgery | Length of time in ICU |
| Duration of hospitalization | within 30 days of index surgery | Duration of hospitalization |
| Hospital readmission or unplanned hospital visit | within 30 days of index surgery | Number of hospital readmissions or unplanned hospital visits |
| Change in Quality of life | 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 |
Countries
China
Contacts
CONTACTHao Zhang, M.D. Ph.D.
STUDY_DIRECTORLin Han, M.D. Ph.D.
Naval Medical University Changhai Hospital
STUDY_DIRECTORHuishan Wang, M.D. Ph.D.
The General Hospital of Northern Theater Command
PRINCIPAL_INVESTIGATORHao Zhang, M.D. Ph.D.
Naval Medical University Changhai Hospital
PRINCIPAL_INVESTIGATORYuji Zhang, M.D. Ph.D.
The General Hospital of Northern Theater Command
Outcome results
None listed