跳至主要内容
临床试验/NCT04122807
NCT04122807Unknown早期 1 期

Cryoablation of the Retrograde Fast Pathway as Treatment for AVNRT

Lawson Health Research Institute2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年11月最近更新:
适应症

试验速览

阶段
早期 1 期
入组人数
20
试验地点
2
主要终点
Termination of AVNRT

研究概览

简要总结

In this study a new technique for ablation in atrioventricular nodal reentrant tachycardia using cryo-energy will be studied in cases where the standard approach has higher risk.

详细描述

Atrioventricular nodal reentrant tachycardia (AVNRT) is the most common cause of fast heartbeats in young people. People with AVNRT have two pathways within the heart, the fast pathway (FP) and slow pathway (SP). A treatment for AVNRT is ablation (burning or freezing) of the SP. This can be done with either radiofrequency or cryo-energy. A complication which occurs in 1% of cases is AV block (AVB), meaning the person needs a pacemaker.

Slow pathway ablation is a problem in people when the electrocardiogram (ECG) shows a long PR interval, with greater rates of AVB. This accounts for 5% of AVNRT cases. A possible solution is to treat the FP with cryo-energy and leave the SP intact. This pilot study aims to show this is safe and effective.

研究设计

研究类型
Interventional
分配方式
Non 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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Documented supraventricular tachycardia (SVT)
  • Planned to undergo electrophysiology (EP) study and ablation
  • PR interval on ECG <220ms (Group 1) or >220ms (Group 2)

排除标准

  • Pregnancy
  • Age <18 years
  • Inability to provide consent
  • High likelihood of tachycardia mechanism other than AVNRT (e.g. Pre-excitation on surface ECG, atrial tachycardia)

结局指标

主要结局

Termination of AVNRT

时间窗: One day

Number of participants where cryotherapy terminates AVNRT

次要结局

  • Incidence of AV block(1 year)
  • Vascular complications(1 year)
  • Cardiac tamponade(1 year)
  • Freedom from recurrence(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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