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

Study Overview
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Brief Summary
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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
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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?

Official Title
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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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: maze procedure
* Procedure: mitral valve surgery
* Procedure: left atrial reduction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MVS + maze<br>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. | Procedure: maze procedure<br>* 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.<br>* Other names: radiofrequency ablation;Procedure: mitral valve surgery<br>* 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.<br>* Other names: mitral velve replacement;|
| Experimental: MVS + maze + LA reduction<br>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. | Procedure: maze procedure<br>* 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.<br>* Other names: radiofrequency ablation;Procedure: mitral valve surgery<br>* 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.<br>* Other names: mitral velve replacement;Procedure: left atrial reduction<br>* 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.<br>* Other names: left atrial volume reduction;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from atrial fibrillation |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of significant adverse events |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Mitral valve