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

NCT ID: NCT02047279

Last Updated: 2017-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-09-30

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?

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MVS + maze

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.

Group Type: ACTIVE_COMPARATOR

maze procedure

Intervention Type: 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.

mitral valve surgery

Intervention Type: PROCEDURE

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

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.

Group Type: EXPERIMENTAL

maze procedure

Intervention Type: 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.

mitral valve surgery

Intervention Type: PROCEDURE

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.

left atrial reduction

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

surgical ablation; radiofrequency ablation; mitral valve repair; mitral velve replacement; left atrial volume reduction

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role: lead

Responsible Party

Alexander Bogachev-Prokophiev

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander V Bogachev-Prokophiev, PhD

Role: PRINCIPAL_INVESTIGATOR

Meshalkin Research Institute of Pathology of Circulation

Locations

Novosibirsk State Research Institute of Circulation Pathology

Novosibirsk, , Russia

Countries

Russia

Other Identifiers

14-04-31491

Identifier Type: -

Identifier Source: org_study_id