Posterior pericardiotomy for prevention of atrial fibrillation and pericardial effusion after aortic valve replacement
- Conditions
- Cardiac surgery ? postoperative atrial fibrillation and pericardial effusionSurgery
- Registration Number
- ISRCTN11129539
- Lead Sponsor
- Kuban State Medical University (Russia)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 150
1. Age 18-69 years
2. Informed consent obtained
3. Isolated primary aortic valve replacement
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Mortality<br>2. The incidence of stroke<br>3. The incidence of cardiac tamponade<br><br>Concerned to in-hospital period.
- Secondary Outcome Measures
Name Time Method 1. The incidence of atrial fibrillation, measured with 48-h ECG monitoring and then with daily ECG<br>2. The incidence of pericardial effusion measured by echo twice after removing chest tubes and before discharge<br>3. The incidence of left pleural effusion measured by echo twice after removing chest tubes and before discharge<br>4. Length of stay in hospital