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临床试验/NCT00851279
NCT00851279已完成4 期

Stereotaxis Study To Obliterate Persistent Ventricular Tachycardia: Data Collection of Clinical Scar-related VT Cases

Stereotaxis8 个研究点 分布在 3 个国家目标入组 53 人开始时间: 2009年6月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
Stereotaxis
入组人数
53
试验地点
8
主要终点
Percentage of Participants Free From VT at 1 Year Post-Treatment

研究概览

简要总结

This is a prospective, non-randomized, multi-center clinical case series evaluating the outcomes of the magnetic navigation system in ventricular tachycardia (VT) cases. Subjects will be evaluated acutely and will be followed clinically at 1, 6 and 12 months post-treatment.

详细描述

Catheter ablation of ventricular tachycardia (VT) is greatly facilitated by using a substrate mapping approach - that is, mapping of the left ventricle during sinus or paced rhythm to identify diseased myocardium. Using three dimensional electroanatomical mapping, it is possible to reconstruct an anatomical rendering of the left ventricle based on voltage. For hemodynamically stable or unstable VTs, various electrophysiologic maneuvers can then be used to identify the critical portions of the VT circuit within the scar (entrainment mapping, identification of diastolic potentials, identification of electrically-unexcitable scar, fractionated potentials and pace mapping).

These methods are limited by the resolution of the substrate map, accuracy of catheter manipulation, and operator skill. To this end, a magnetic navigation system has been developed that allows for remote cardiac mapping. When used in concert with a compatible electroanatomical mapping system, it is possible to create a high-density ventricular substrate map of healed myocardial infarction. By removing the necessity for technical skill with catheter manipulation, this system has the potential for both improving the efficacy of VT ablation and expanding the clinical use of this substrate mapping approach.

Recently, a higher-powered, irrigated tip catheter has become available in certain markets for use in cardiac arrhythmia ablations. This study will evaluate the outcomes of using this magnetic irrigation ablation catheter during mapping and ablation of VT while also using remote magnetic navigation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Subject must be between the ages of 18 - 80 years
  • Willing to provide prior written informed consent per local ethics committee guidelines
  • Subjects must present with ventricular tachycardia, characterized by: history of myocardial scar and spontaneous ventricular tachycardia
  • Able to be safely exposed to static magnetic fields
  • No in-situ devices are present or any in-situ devices have been verified to be compatible to magnetic fields

排除标准

  • Presence of a mobile ventricular thrombus
  • Inability to access the left ventricle
  • Subjects must not have any contraindications to short-term anticoagulation
  • Subjects must not have a life expectancy of <1 year due to a medical illness

结局指标

主要结局

Percentage of Participants Free From VT at 1 Year Post-Treatment

时间窗: 1 Year follow-up

In order to qualify for inclusion in the chronic success statistic, patients must first be an acute success and must have had no VTs identified in their ICD history post ablation therapy.

次要结局

未报告次要终点

研究者

发起方
Stereotaxis
申办方类型
Industry
责任方
Sponsor

研究点 (8)

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