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Ablation and Left Atrium Reduction During Mitral Valve Surgery for Atrial Fibrillation (ALARM-vs-AF)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
maze procedure
mitral valve surgery
left atrial reduction
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Mitral valve

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novosibirsk State Research Institute of Circulation Pathology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

MVS + maze

MVS + maze + LA reduction

Arm Description

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, 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.

Outcomes

Primary Outcome Measures

Freedom from atrial fibrillation

Secondary Outcome Measures

Rate of significant adverse events

Full Information

First Posted
January 24, 2014
Last Updated
September 7, 2017
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT02047279
Brief Title
Ablation and Left Atrium Reduction During Mitral Valve Surgery for Atrial Fibrillation
Acronym
ALARM-vs-AF
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, Mitral valve

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MVS + maze
Arm Type
Active Comparator
Arm Description
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.
Arm Title
MVS + maze + LA reduction
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
maze procedure
Other Intervention Name(s)
surgical ablation, radiofrequency ablation
Intervention Description
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
Intervention Name(s)
mitral valve surgery
Other Intervention Name(s)
mitral valve repair, mitral velve replacement
Intervention Description
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
Intervention Name(s)
left atrial reduction
Other Intervention Name(s)
left atrial volume reduction
Intervention Description
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 Measure Information:
Title
Freedom from atrial fibrillation
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Rate of significant adverse events
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander V Bogachev-Prokophiev, PhD
Organizational Affiliation
Meshalkin Research Institute of Pathology of Circulation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novosibirsk State Research Institute of Circulation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation

12. IPD Sharing Statement

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

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