跳至主要内容
临床试验/NCT04215640
NCT04215640已完成不适用

Radiofrequency Ablation of Paroxysmal Supraventricular Tachycardia Using a Novel Catheter Equipped With Mini Electrodes

Yong Seog Oh2 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2020年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
136
试验地点
2
主要终点
RF time (seconds) to successful ablation

研究概览

简要总结

Paroxysmal supraventricular tachycardia is treated with radiofrequency ablation recently. This procedure is performed by ablating slow pathway or accessory pathway using radiofrequency ablation catheter. Recently developed mirofidelity (MIFI) catheter has mini-electrodes that can record local eletrogram with higher resolution. We aimed to investigate the efficacy of MIFI catheter in the ablation of paroxysmal supraventricular tachycardia compared to conventional radiofrequency ablation catheter. Enrolled patients undergo conventional electrophysiologic study. Patients with sustained supraventricular tachycardia during the study are randomized to either study group or control group. Radiofrequency ablation is performed using MIFI catheter in the study group, and conventional catheter (Blazer II) in the control group. The study endpoints are recorded immediately after ablation and there is no additional follow up or management after procedure.

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
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are scheduled to undergo radiofrequency ablation for paroxysmal supraventricular tachycardia or WPW syndrome with atrial fibrillation
  • Give written informed consent for the study

排除标准

  • Unable to induce supraventricular tachycardia during electrophysiologic study.
  • Cognitive impairment to understand study procedure

结局指标

主要结局

RF time (seconds) to successful ablation

时间窗: At the end of radiofrequency ablation procedure

For AVNRT, the time (seconds) from the beginning of radiofrequency ablation to the emergence of junctional rhythm For AVRT, the time (seconds) from the beginning of radiofrequency ablation to the accessory pathway block

RF application number

时间窗: At the end of radiofrequency ablation procedure

Number of radiofrequency ablation attempt to successful ablation

次要结局

  • Total ablation time (seconds)(At the end of radiofrequency ablation procedure)
  • Presence of either acute reconnection or reinduction(At the end of radiofrequency ablation procedure)

研究者

发起方
Yong Seog Oh
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yong Seog Oh

professor

Seoul St. Mary's Hospital

研究点 (2)

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