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This study evaluates the safety and efficiency of surgical prevention of atrial fibrillation in patients with valvular heart disease and left atrium enlargement
Preservation or appearance of AF(atrial fibrillation) after mitral valve surgery substantially reduce the number of excellent and good results of the operation in the long-term period, causing circulatory insufficiency, increased pulmonary hypertension, increasing the risk of thromboembolic events and stroke.
Significant predictors of AF after surgery are the initial size of the left atrium more than 6.0 cm, stenotic lesions and rheumatic genesis of mitral defect. 80% of patients in this group had AF during the first year after operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| without prevention | Placebo Comparator | isolated mitral valve replacement or reconstruction, implantation of cardiac monitor |
|
| group of prevention | Active Comparator | mitral valve replacement or reconstruction with surgical prevention of AF (concomitant ablation of the left atrium) and implantation of cardiac monitor. Prophylactic surgical ablation is performed to prevent AF in patients during mitral valve surgery. Ablation is performed by radiofrequency electrode or cryoprobe. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surgical prevention of atrial fibrillation | Procedure | Prophylactic surgical ablation is performed to prevent AF in patients during mitral valve surgery. Ablation is performed by radiofrequency electrode or cryoprobe. Pulmonary veins, posterior wall of the left atrium will be isolated by the scheme box-lesion with additional lines to the mitral valve and appendage of left atrium. |
| Measure | Description | Time Frame |
|---|---|---|
| composite outcome measure of complications | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| number of participants with freedom from AF according to the long-term ECG monitoring | 1 year | |
| transport function of the left atrium according to TTE (transthoracic echo) | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MeshalkinRI | Novosibirsk | 630055 | Russia |
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|
| cardiomonitor | Device | in both groups cardiac rhythm will be controlled by a cardiomonitor |
|
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D012214 | Rheumatic Heart Disease |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012213 | Rheumatic Fever |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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