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临床试验/NCT03915691
NCT03915691进行中(未招募)不适用

Isthmus Guided vs Anatomical Linear Ablation in the Treatment of Scar Related Atrial Tachycardia

Liverpool Heart and Chest Hospital NHS Foundation Trust6 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2022年8月16日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
201
试验地点
6
主要终点
Atrial arrhythmia recurrence

研究概览

简要总结

Atrial tachycardia is a symptomatic arrhythmia, for which an effective treatment is a catheter ablation procedure. The goal of the Ripple AT-Plus study is to evaluate two methods of performing catheter ablation for atrial tachycardia. The main outcome assessed during the study is long-term recurrence of atrial tachycardia following the catheter ablation procedure.

详细描述

Catheter based mapping of the electrical signals in the heart during atrial tachycardia can identify areas that require ablation in order to treat the arrhythmia. There are numerous methods by which to map atrial tachycardia. Isthmus guided ablation using Ripple Mapping is one such method, and has recently been demonstrated to improve diagnostic accuracy of mapping and therefore improve acute procedural outcomes (termination of the tachycardia).

However, it is not known if improved acute procedural outcomes translate into long-term benefits for patients. At present, the recurrence rate following atrial tachycardia ablation is near 30%. We hypothesise that isthmus guided ablation using Ripple Mapping can reduce long-term recurrence following ablation as improved diagnostic accuracy of mapping can lead to more targeted, less extensive, ablation.

Patients referred for catheter ablation of atrial tachycardia will be randomised to undergo the procedure by isthmus targeted approach using Ripple Mapping or conventional approach using local activation time. Otherwise, the catheters used to perform the mapping and ablation will be the same in both groups. After the procedure, follow up will occur at 1 year with a further Holter Montior. Any arrhythmia recurrence will be documented and the two arms will be compared for acute success, 12 month success, ablation required and procedure time.

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

  • Referred for catheter ablation of AT by the direct care team, based on clinical indication.
  • Male or female, aged >18 years old.
  • Able to consent for recruitment to the trial and the catheter ablation procedure.

排除标准

  • Contraindication to catheter ablation as deemed by the clinical team.
  • Typical atrial flutter or AF on ECG.

结局指标

主要结局

Atrial arrhythmia recurrence

时间窗: 12 months

Any confirmed episode of atrial arrhythmia (\>30 seconds on Holter or 12 lead ECG) occurring in the 12 months after catheter ablation.

次要结局

  • Acute success during the catheter ablation procedure without the need of entrainment.(Procedure.)
  • Total procedure time.(Procedure.)
  • Acute success during the catheter ablation procedure by the first ablation set.(Procedure.)
  • Ablation required(Procedure.)
  • Procedure failure.(Procedure.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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