Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation, Mitral valve
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?
Interventions
PROCEDUREmaze 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.
PROCEDUREmitral 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.
PROCEDUREleft 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.
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from atrial fibrillation | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Rate of significant adverse events | 12 months |
Countries
Russia
Outcome results
None listed