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

Sponsor

Meshalkin Research Institute of Pathology of Circulation (Other)

Overall Status

Completed

CT.gov ID

NCT02474108

Collaborator

(none)

Enrollment

Location

Arms

19.6

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates the safety and efficiency of surgical prevention of atrial fibrillation in patients with valvular heart disease and left atrium enlargement

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Rheumatic Heart Disease	Procedure: surgical prevention of atrial fibrillation Device: cardiomonitor	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 2, 2015

Actual Primary Completion Date :

May 5, 2016

Actual Study Completion Date :

Oct 20, 2016

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: without prevention isolated mitral valve replacement or reconstruction, implantation of cardiac monitor	Device: cardiomonitor in both groups cardiac rhythm will be controlled by a cardiomonitor
Active Comparator: group of prevention 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 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. Device: cardiomonitor in both groups cardiac rhythm will be controlled by a cardiomonitor

Arm

Intervention/Treatment

Placebo Comparator: without prevention

isolated mitral valve replacement or reconstruction, implantation of cardiac monitor

Device: cardiomonitor

in both groups cardiac rhythm will be controlled by a cardiomonitor

Active Comparator: group of prevention

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

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.

Device: cardiomonitor

in both groups cardiac rhythm will be controlled by a cardiomonitor

Outcome Measures

Primary Outcome Measures

composite outcome measure of complications [up to 1 year]

Secondary Outcome Measures

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]