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Completed

NCT Number: NCT02047279

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Novosibirsk State Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

maze procedure

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.

Other names: surgical ablation, radiofrequency ablation

Mitral valve surgery

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.

Other names: mitral valve repair, mitral velve replacement

left atrial reduction

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.

Other names: left atrial volume reduction

Primary outcomes

  1. Freedom from atrial fibrillation

    Time frame: 12 months

Secondary outcomes

  1. Rate of significant adverse events

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study 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

Acronym: ALARM-vs-AF

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 28, 2014
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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