PV-Isolation for Paroxysmal Atrial Fibrillation: Isolation of the Arrhythmogenic Vein(s) vs. Isolation of All Veins
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 212
- 试验地点
- 2
- 主要终点
- freedom of atrial tachycardia 6 months after ablation
研究概览
简要总结
We conduct a randomized study comparing the safety and effectiveness of two interventional ablation techniques for treatment of paroxysmal atrial fibrillation: the segmental pulmonary vein ablation approach, (1) with empiric isolation of all pulmonary veins or (2) Segmental Isolation of the arrhythmogenic pulmonary vein(s)
详细描述
BACKGROUND Atrial fibrillation ablation procedures typically involve isolation of all pulmonary veins (PVs), yet the need for such an extensive ablation strategy in all patients is unclear.
OBJECTIVE:
We conduct a randomized study comparing the safety and effectiveness of two interventional ablation techniques for treatment of paroxysmal atrial fibrillation: the segmental pulmonary vein ablation approach, (1) with empiric isolation of all pulmonary veins or (2) Segmental Isolation of only the arrhythmogenic pulmonary vein(s). The single-blind interventional, randomized study will include 106 patients in each arm.
A reablation procedure, with the use of the same technique as the first ablation, will be offered to the patient in case of a symptomatic atrial fibrillation recurrence beyond the third month after the ablation procedure.
Follow-Up After discharge, patients w ill be scheduled for repeated visits in the arrhythmia clinic at 3 and 6 months after the first ablation. At each of these visits, intensive questioning for arrhythmia-related symptoms (fatigue, dizziness, and nausea) since the last follow-up visit was performed, especially for those that the patient had experienced before ablation. At every follow-up visit, 7-day Holter monitoring w ill be performed. Multislice CT or MRI of the pulmonary vein w ill be obtained before and 3 months after the ablation procedure for evaluation of the pulmonary vein anatomy and for detection of radiofrequency ablation-induced pulmonary vein stenosis .
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients between 18 and 80 years old with paroxysmal atrial fibrillation
- •Episodes with a maximum duration for 7 days
- •at least 4 episodes / month
- •at least one attempt with Class I or III anti-arrhythmic drugs and/or with ß-blockers without success
- •sufficient oral anticoagulation for a minimum of four weeks previous to ablation
排除标准
- •hyperthyroidism
- •mitral regurgitation > II°
- •intracardiac thrombi documented by transesophageal echocardiography
- •left ventricular ejection< fraction 35%,
- •history of ablation, myocardial infarction or cardiac surgery in the previous 3 months
- •history of left-atrial ablation procedure
- •contraindication for oral anticoagulation
结局指标
主要结局
freedom of atrial tachycardia 6 months after ablation
时间窗: 6 months
次要结局
- freedom of symptoms due to atrial tachycardia 6 months after ablation safety(6 months)