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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Freedom from atrial fibrillation
研究概览
简要总结
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.
详细描述
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?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Freedom from atrial fibrillation
时间窗: 12 months
次要结局
- Rate of significant adverse events(12 months)
研究者
Alexander Bogachev-Prokophiev
PhD
Meshalkin Research Institute of Pathology of Circulation