A Randomized Trial of the Ostial Versus the Extra-Ostial Ablation Strategy for Atrial Fibrillation (LASso Vs CARto)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- overall efficacy (= freedom from symptomatic, ECG documented AF or organized LA tachycardia (with a duration of > 10 min) without receiving antiarrhythmic medication)
研究概览
简要总结
Both segmental, ostial and circumferential, extra-ostial pulmonary vein (PV) isolation have been proven effective in the treatment of atrial fibrillation.
In this study patients with symptomatic paroxystic or persistent AF were randomised to one of the above mentioned ablation methods. The primary endpoints were recurrent AF and recurrence of left atrium-PV conduction.
详细描述
Both segmental, ostial and circumferential, extra-ostial pulmonary vein (PV) isolation have been proven effective in the treatment of atrial fibrillation.
In this study with symptomativ paroxystic or persistent AF were randomised to one of the above mentioned ablation methods. Each patient was allowed a maximum of two ablation procedures. Holter monitoring for 14-days periods will be performed at 3 months after ablation. The patiens are seen at out-patient visits at 1, 3, 6, 9, and 12 months after the ablation procedure.
Primary endpoints were recurrent AF and recurrence of left atrium-PV conduction.
Secondary endpoints were:
- safety
- resumption of LA-PV conduction
- alterations in neurohormones
- socio-economics aspects(cost effectiveness)
- changes in inflammatory markers
- quality of life
- alterations in signal averaged P wawe signals
- evaluation of the predictive value of these variables to predict recurrence of AF
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Ect
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •symptomatic paroxysmal or persistent AF for more than 6 months, with at least 3 episodes in 3 months and with insufficient effect of at least 2 pharmacological regimens
排除标准
- •congenital heart disease
- •age under 18 years
- •significant valve disease
- •left atrial size > 55 mm
- •prior ablation for AF
- •Severe heart failure (LVEF < 20 % and/or NYHA class IV)
结局指标
主要结局
overall efficacy (= freedom from symptomatic, ECG documented AF or organized LA tachycardia (with a duration of > 10 min) without receiving antiarrhythmic medication)
次要结局
- - safety
- - resumption of LA-PV conduction
- - neurohormones
- - socio-economics (cost effectiveness)
- - inflammatory markers
- - quality of life
- - signal averaged P wave signals-