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

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: maze procedure; Procedure: mitral valve surgery; Procedure: left atrial reduction

• Registration Number: NCT02047279
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief 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?

Study Timeline

• Study First Submitted: 2014-01-24
• Study First Submitted QC: 2014-01-24
• Study First Posted: 2014-01-28
• Study Start: 2014-09
• Status Verified: 2017-09
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Last Update Submitted: 2017-09-07
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Able to sign Informed Consent and Release of Medical Information forms
• Age ≥ 18 years
• Clinical indications for mitral valve surgery for organic mitral valve disease Note: May include need for surgical management of functional tricuspid regurgitation or patent foramen ovale. Surgical intervention may be performed via sternotomy or minimally invasive procedure.
• a) Persistent atrial fibrillation (AF) within 6 months prior to randomization, defined as non self-terminating AF lasting greater than 7 days but no more than one year, or lasting less than 7 days but necessitating pharmacologic or electrical cardioversion.

Duration of AF must be documented by medical history and Presence of AF must be documented by a direct electrocardiographic assessment within 6 months prior to randomization.

b) Longstanding persistent AF is defined as continuous AF of greater than one year duration.

Duration of AF must be documented by medical history and Presence of AF must be documented by a direct electrocardiographic assessment upon arrival in the OR.

• left atrial diameter > 65mm
• Able to use heart rhythm monitor

Exclusion Criteria

• AF is paroxysmal
• AF without indication for mitral valve surgery
• Concomitant coronary artery bypass grafting (CABG), aortic arch or aortic valve procedure
• Previous catheter ablation for AF
• Redo cardiac surgery
• Left ventricle ejection fraction (LV EF) < 35%
• Life expectancy of less than one year
• Mental impairment or other conditions that may not allow subject to understand the nature, significance, and scope of study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MVS + maze	mitral valve surgery	Procedure: Maze procedure, mitral valve surgery 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. 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.
MVS + maze + LA reduction	left atrial reduction	Procedure: maze procedure, mitral valve surgery, left atrial reduction 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. 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. 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.
MVS + maze	maze procedure	Procedure: Maze procedure, mitral valve surgery 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. 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.
MVS + maze + LA reduction	maze procedure	Procedure: maze procedure, mitral valve surgery, left atrial reduction 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. 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. 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.
MVS + maze + LA reduction	mitral valve surgery	Procedure: maze procedure, mitral valve surgery, left atrial reduction 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. 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. 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.

Primary Outcome Measures

Name	Time	Method
Freedom from atrial fibrillation	12 months

Secondary Outcome Measures

Name	Time	Method
Rate of significant adverse events	12 months

Trial Locations

Locations (1)

Novosibirsk State Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation