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临床试验/NCT02083016
NCT02083016已完成4 期

Ultra-high Density Mapping With Multielectrode Catheter vs Conventional Point by Point Mapping for Ventricular Tachycardia Substrate Ablation

Hospital Clinic of Barcelona1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年4月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
20
试验地点
1
主要终点
Mapping and ablation times

研究概览

简要总结

Ultra-high density mapping with multielectrode catheter may improve slow conduction channels identification in ventricular tachycardia substrate ablation procedures compared to conventional point by point mapping.

This study compares the ability of both mapping catheters to detect slow conduction channels in areas of myocardial scar and their utility to assess substrate modification after ablation.

详细描述

This is a prospective, randomized controlled study. Twenty patients with sustained ventricular tachycardia and structurally abnormal ventricle(s) will be prospectively enrolled. In all patients a detailed pre and post-ablation electroanatomical mapping will be performed, and these maps will be merged with CT and/or MRI images. Patients will be randomly assigned to two groups. In Group A patients both pre and post-ablation mapping will be performed firstly by conventional point by point mapping using a Navistar Thermocool catheter, and secondly by multielectrode contact mapping using a Pentaray catheter. In this group, target ablation sites will be guided by point by point map. In Group B patients, both pre and post-ablation mapping will be performed firstly by multielectrode contact mapping using a Pentaray catheter, and secondly by conventional point by point mapping using a Navistar Thermocool catheter. In this group target ablation sites will be guided by multielectrode contact mapping.

Slow conduction channels will be identified by color-coded voltage map adjustment of the lower and upper thresholds and also the presence of fractioned electrograms with the delayed component showing sequential orthodromic activation. The entrances of these channels will be the target of the ablation sites (scar dechanneling technique).

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with indication for ventricular tachycardia substrate ablation.

排除标准

  • •Pregnant woman.
  • •Reduced expectancy of life (less than 12 months)
  • •Patient participating in another clinical study that investigates a drug or device
  • •Psychologically unstable patient or denies to give informed consent
  • •Any cause that contraindicate ablation procedure or antiarrhythmic drug

研究组 & 干预措施

Conventional Mapping

Other

Both pre and post-ablation mapping will be performed firstly by conventional point by point mapping using a Navistar Thermocool catheter, and secondly by multielectrode contact mapping using a Pentaray catheter. In this group, ablation will be guided by conventional mapping.

干预措施: Ablation guided by conventional mapping. (Device)

Multielectrode mapping.

Other

Both pre and post-ablation mapping will be performed firstly by multielectrode contact mapping using a Pentaray catheter, and secondly by conventional point by point mapping using a Navistar Thermocool catheter. In this group ablation will be guided by multielectrode contact mapping.

干预措施: Ablation guided by ultra-high density mapping with multielectrode catheter. (Device)

结局指标

主要结局

Mapping and ablation times

时间窗: During procedure.

Mapping and ablation times with each mapping system (point by point vs multielectrode mapping).

次要结局

  • Scar area correlation with MRI.(Immediately after intervention.)
  • Radiofrequency delivery time.(During procedure.)
  • Reduction of residual electrograms with delayed component.(Immediately after intervention.)
  • Ventricular tachycardia inducibility after ablation.(Immediately after intervention.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Berruezo, MD, PhD

MD

Hospital Clinic of Barcelona

研究点 (1)

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