NCT02047279

Ablation and Left Atrium Reduction During Mitral Valve Surgery for Atrial Fibrillation

Left Atrium Reduction Versus no Left Atrium Reduction for Patients With Enlarged Left Atria and Persistent or Long Standing Persistent Atrial Fibrillation Undergoing Mitral Valve Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Meshalkin Research Institute of Pathology of Circulation · Network
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to estimate left atrial volume reduction surgery concomitant with the maze procedure and mitral valve repair/replacement in patients with atrial fibrillation with an enlarged left atria.

Detailed description

The Cox-Maze procedure has been a gold standard for the treatment of atrial fibrillation. Success of the modified maze procedure after valvular operation with an enlarged left atria and persistent and longstanding persistent atrial fibrillation remains suboptimal. The question addressed was: In adults undergoing a maze procedure for atrial fibrillation does left atrial size reduction compared to maze surgery alone improve maze surgery success?

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	maze procedure	The scheme of lesion pattern: "box" lesion + line to mitral valve + line from "box" to left atrial appendage. The ablation procedure was performed by using a dry bipolar radiofrequency ablation clamp. The left atrial appendage was excluded in all cases.
PROCEDURE	mitral valve surgery	For mitral regurgitation or stenosis, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, a valve replacement will be performed.
PROCEDURE	left atrial reduction	The enlarged left atria are plicated (suture technique) between the left and right pulmonary vein down to the inferior end of left atrial incision on the half-moon shape.

Timeline

• Start date: 2014-09-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2014-01-28
• Last updated: 2017-09-11

Locations

1 site across 1 country: Russia