Plain English Summary
Background and study aims
In patients who underwent a heart surgery called coronary artery bypass graft (CABG), posterior pericardiotomy (a surgical procedure carried out on the pericardium of the heart) has been shown to be protective against postoperative atrial fibrillation (abnormal heart rate after heart surgery). This study aims to find out whether it could help patients who underwent valve surgery.
Who can participate?
Patients admitted for aortic valve replacement surgery can participate in this study.
What does the study involve?
Patients are divided randomly into two groups. One group receives posterior pericardiotomy during the valve replacement surgery and the other group, called the control group, receives the standard surgical technique.
What are the possible benefits and risks of participating?
This technique may reduce the occurrence of postoperative atrial fibrillation and accumulation of fluid around the heart in patients who underwent aortic valve replacement surgery.
Where is the study run from?
This study is run from Ochapowski Regional Hospital, Russia.
When is the study starting and how long is it expected to run for?
The study started in October 2013 and is expected to run for 1.5 years.
Who is funding the study?
The study is funded by the Kuban State Medical University, Russia.
Who is the main contact?
Dr Vasily Kaleda
Dr Vasily Kaleda
The efficacy of posterior pericardiotomy in prevention of atrial fibrillation and pericardial effusion after aortic valve replacement
The hypothesis is that posterior pericardiotomy can reduce the incidence of atrial fibrillation and pericardial effusion after aortic valve replacement.
Kuban State Medical University Ethics Comimttee, 01/10/2013, Protocol #22
Single-centre non-blinded randomised controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Cardiac surgery postoperative atrial fibrillation and pericardial effusion
Patients will be randomised to two groups: intervention and control
1. Intervention group: will undergo posterior pericardiotomy in addition to conventional aortic valve replacement
2. Control group: will undergo only conventional aortic valve replacement
Primary outcome measures
2. The incidence of stroke
3. The incidence of cardiac tamponade
Concerned to in-hospital period.
Secondary outcome measures
1. The incidence of atrial fibrillation, measured with 48-h ECG monitoring and then with daily ECG
2. The incidence of pericardial effusion measured by echo twice after removing chest tubes and before discharge
3. The incidence of left pleural effusion measured by echo twice after removing chest tubes and before discharge
4. Length of stay in hospital
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Age 18-69 years
2. Informed consent obtained
3. Isolated primary aortic valve replacement
Target number of participants
Participant exclusion criteria
1. Known history of atrial fibrillation before surgery
2. Amiodarone intake before surgery
3. Known history of thyrotoxicosis
4. Pericardial effusion with a maximum pericardial separation of more than 0.5 cm by transthoracic echocardiography (TTE) before surgery
5. Severe chronic obstructive pulmonary disease (COPD)
6. Left ventricular ejection fraction (LVEF) <30%
7. Left atrium (LA) diameter >50 mm
8. Pericardial adhesions
9. Any active inflammatory disease at the time of surgery (including active infection endocarditis)
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
140, Rossiyskaya str.
Kuban State Medical University (Russia)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Publication in a high-impact peer reviewed journal.
IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
Participant level data
To be made available at a later date
Results - basic reporting