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

The efficacy of posterior pericardiotomy in prevention of atrial fibrillation and pericardial effusion after aortic valve replacement

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11129539
Enrollment
150
Registered
2014-01-08
Start date
2013-10-17
Completion date
Unknown
Last updated
2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac surgery ? postoperative atrial fibrillation and pericardial effusion Surgery

Interventions

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

Sponsors

Kuban State Medical University (Russia)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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) 50 mm 8. Pericardial adhesions 9. Any active inflammatory disease at the time of surgery (including active infection endocarditis)

Design outcomes

Primary

MeasureTime frame
1. Mortality 2. The incidence of stroke 3. The incidence of cardiac tamponade Concerned to in-hospital period.

Secondary

MeasureTime frame
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

Countries

Russian Federation

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 26, 2026