Surgical Prevention of Atrial Fibrillation in Patients With Rheumatic Mitral Valve Lesion and Left Atrium Enlargement

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Pilot, Randomized,Single Blind Trial of Surgical Prevention of Atrial Fibrillation in Patients With Rheumatic Mitral Valve Lesion

Conditions
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Atrial Fibrillation, Rheumatic Heart Disease

Intervention / Treatment
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* Procedure: surgical prevention of atrial fibrillation
* Device: cardiomonitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: rheumatic mitral valve lesion the absence a history of AF sinus rhythm left atrium size more than 6.0 cm Exclusion Criteria: refusal to participate in the study aortic stenosis / regurgitation coronary atherosclerosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: without prevention<br>isolated mitral valve replacement or reconstruction, implantation of cardiac monitor | Device: cardiomonitor<br>* in both groups cardiac rhythm will be controlled by a cardiomonitor<br>|
| Active Comparator: group of prevention<br>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. | Procedure: surgical prevention of atrial fibrillation<br>* 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.<br>Device: cardiomonitor<br>* in both groups cardiac rhythm will be controlled by a cardiomonitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite outcome measure of complications |  | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, radiofrequency ablation, prevention of AF, mitral valve, left atrium enlargement, cryoablation