NCT02816268已完成不适用
Contact Force Guided Ablation Versus Conventional Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation
Deutsches Herzzentrum Muenchen1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年9月1日最近更新:
适应症
干预措施
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
- 1
- 主要终点
- Number of reconnected pulmonary vein after ablation and a waíting period of 20min
研究概览
简要总结
The investigators prospectively investigate the differences between contact-force guided pulmonary vein isolation (PVI) and conventional pulmonary vein isolation in patients with paroxysmal atrial fibrillation (PAF) with respect to adenosine guided unmasking of dormant conduction, procedural and clinical outcome.
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
- None
入排标准
- 接受健康志愿者
- 否
入选标准
- •Patients (>=18 und < 80 years) with symptomatic paroxysmal AF
- •At least one unsuccessful attempt of antiarrhythmic drug (betablocker or class I oder III).
- •Oral anticoagulation with phenprocoumone, warfarine or DOAKs for at least 4 weeks prior to ablation with weekly documented INR > 2..
- •Withdrawal of antiarrhythmic drugs at least 3 half times prior to ablation except amiodarone.
排除标准
- •Left atrial thrombus
- •Contraindications for oral anticoagulation or adenosin
研究组 & 干预措施
Conventional Pulmonary vein isolation
Other
Conventional pulmonary vein isolation was gained by using an irrigated tip ablation catheter
干预措施: Pulmonary vein isolation (Other)
Contact force pulmonary vein isolation
Other
Contact force was meassured by using the SMART-Touch ablation catheter (Biosense-Webster®)
干预措施: Pulmonary vein isolation (Other)
结局指标
主要结局
Number of reconnected pulmonary vein after ablation and a waíting period of 20min
时间窗: 20min after procedure
次要结局
- Complications due to ablation(30 days)
- Time to first documented recurrence of atrial fibrillation(12 month)
- Number of reconnected pulmonary veins(12 month)
研究者
研究点 (1)
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