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Posterior pericardiotomy for prevention of atrial fibrillation and pericardial effusion after aortic valve replacement

Not Applicable
Completed
Conditions
Cardiac surgery ? postoperative atrial fibrillation and pericardial effusion
Surgery
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
Inclusion Criteria

1. Age 18-69 years
2. Informed consent obtained
3. Isolated primary aortic valve replacement

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)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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
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