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

Atrial Fibrillation Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02047279
• Other study ID #: 14-04-31491
• Status: Completed
• Phase: N/A
• First received: January 24, 2014
• Last updated: September 7, 2017
• Start date: September 2014
• Est. completion date: September 2017

Study information

• Verified date: September 2017
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Russian Federation	Novosibirsk State Research Institute of Circulation Pathology	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from atrial fibrillation		12 months
Secondary	Rate of significant adverse events		12 months