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临床试验/NCT02019407
NCT02019407已完成不适用

Prospective Randomized Study on Clinical Effectiveness of Carvo-Tricuspid Isthmus Block in Patients With Paroxysmal Atrial Fibrillation

Yonsei University2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2015年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
128
试验地点
2
主要终点
Recurrence of Atrial fibrillation (AF free survival)

研究概览

简要总结

Prospective Randomized Study on Clinical Effectiveness of Carvo-Tricuspid Isthmus (CTI) Block in Patients with Paroxysmal Atrial Fibrillation (PAF) will be performed. Study will be composed with two arms including 4 pulmonary vein isolation and pulmonary vein isolation with CTI block. After that all patients will be followed up by HRS(Heart Rhythm Society) 2010 expert consensus guideline.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with documented AF
  • Drug refractory AF
  • Non-valvular AF
  • No structural cardiac disease
  • No intracardiac thrombi in cardiac CT and TEE

排除标准

  • permanent AF refractory to electrical cardioversion
  • LA size >55 mm as measured by echocardiography
  • AF with valvular disease
  • associated structural heart disease other than left ventricular hypertrophy
  • prior AF ablation.

研究组 & 干预措施

CTI group

Experimental

CTI(Cavo-Tricuspid Isthmus)

干预措施: PVI, CTI block (Procedure)

Non CTI group

Placebo Comparator

Non CTI (Cavo-Tricuspid Isthmus)

干预措施: PVI (Procedure)

结局指标

主要结局

Recurrence of Atrial fibrillation (AF free survival)

时间窗: 3 month after catheter ablation

clinical recurrence of AF after catheter ablation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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