NCT02474108

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Meshalkin Research Institute of Pathology of Circulation · Network
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Atrial Fibrillation
• Rheumatic Heart Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-03-02
• Primary completion: 2016-05-05
• Completion: 2016-10-20
• First posted: 2015-06-17
• Last updated: 2017-09-11

Locations

1 site across 1 country: Russia