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临床试验/NCT01584154
NCT01584154Unknown4 期

CRYOthermy and Radiofrequency ABLation For AVNRT TrEatment

Princess Margaret Hospital, Hong Kong1 个研究点 分布在 1 个国家目标入组 520 人开始时间: 2012年3月1日最近更新:
适应症

试验速览

阶段
4 期
发起方
入组人数
520
试验地点
1
主要终点
treatment success rate, defined as proportion of treated patients with both atrioventricular block-free acute procedural success and mid-term success without recurrence at 6 months

研究概览

简要总结

The purpose of this study is to compare the safety and effectiveness of cryoablation and radiofrequency ablation in the treatment of the commonest kind of supraventricular tachycardia, namely atrioventricular nodal reentrant tachycardia. The study hypothesis is that cryoablation is non-inferior to radiofrequency.

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

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are referred for catheter ablation of supraventricular tachycardia and diagnosis of AVNRT is made by cardiac electrophysiology study

排除标准

  • Patients who aged less than 18 or over
  • Patients who are pregnant.
  • Patients who cannot give informed consent.
  • Patients who are judged to have severe mental impairment and cannot report symptoms of palpitation during follow-up.
  • Patients who had previous AVNRT ablation before.
  • Patients who have comorbid congenital heart disease.

结局指标

主要结局

treatment success rate, defined as proportion of treated patients with both atrioventricular block-free acute procedural success and mid-term success without recurrence at 6 months

时间窗: 6 months after treatment

次要结局

  • Treatment success rate at 12 months(12 months after treatment)

研究者

发起方
Princess Margaret Hospital, Hong Kong
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ngai Yin Chan

Consultant

Princess Margaret Hospital, Hong Kong

研究点 (1)

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