Assessment of the Effect of Left Atrial Cryoablation Enhanced by Ganglionated Plexi Ablation in the Treatment of Atrial Fibrillation in Patients Undergoing Open Heart Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- Sinus Rhythm
研究概览
简要总结
The aim of our study was to investigate, whether enhancement of left atrial cryoablation by ablation of the autonomic nervous system of left atrium leads to influencing the outcomes of surgical treatment of atrial fibrillation in patients with structural heart disease undergoing open-heart surgery.
详细描述
The observed patient file consisted of 100 patients, who have undergone a combined open-heart surgery at our department between July 2012 and December 2014. The patients were indicated for the surgical procedure due to structural heart disease, and suffered from paroxysmal, persistent, or long-standing persistent atrial fibrillation. In all cases, left atrial cryoablation was performed in the extent of isolation of pulmonary veins, box lesion, connecting lesion with mitral annulus, amputation of the left atrial appendage and connecting lesion of the appendage base with left pulmonary veins. Furthermore, thirty-five of the patients underwent mapping and radiofrequency ablation of ganglionated plexi, together with decision and ablation of the ligament of Marshall.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for open-heart surgery (mitral valve disease and/or tricuspidal valve disease and/or aortic valve disease and/or coronary artery disease and/or other)
- •Concomitant paroxysmal, persistent, long standing persistent atrial fibrillation
- •Signing of the informed consent
排除标准
- •Age below 40 and over 80 years of age
- •Left ventricular ejection fraction below 25%
- •Left atrium diameter over 60mm
- •Permanent atrial fibrillation
- •Polymorbidity (Euroscore II over 10)
- •Emergency surgery
- •Renal insufficiency (creatinine over 200 umol/l)
结局指标
主要结局
Sinus Rhythm
时间窗: 30 months
The primary outcome was establishment and duration of sinus rhythm in the course of one-year follow-up.
次要结局
- Recurrence of Atrial Fibrillation and the Presence of a Mitral Valve Surgery(30 months)