NCT00558857终止1 期
Clinical Feasibility of Using Dynamic Substrate Mapping to Guide Ablation of Ischemic Ventricular Tachycardia
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- Incidence of serious adverse events (SAEs)
研究概览
简要总结
This is a prospective, non-randomized study to determine the feasibility of using a new technique called Dynamic Substrate Mapping (DSM) to help guide the treatment of ischemic ventricular tachycardia (IVT). We hypothesize that DSM will lead to simpler, more effective ablation of IVT. Results from this study will be used to determine if further clinical investigation is warranted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 否
入选标准
- •Have an ICD or CRT-D device
- •Had at least 3 documented device therapies to treat VT over last 3 months
- •Clinical VT is confirmed or suspected to be of ischemic origin
- •Scheduled for VT ablation procedure
- •LVEF > or = 20%
排除标准
- •Inadequate AAD washout (amiodarone should be maintained at current dose)
- •Unstable angina
- •Active ischemia
- •Cardiac surgery within prior 2 months
- •Evidence of infection
- •Prosthetic mitral or aortic valve or mitral/aortic valvular heart disease requiring surgical intervention
- •History of embolic event
- •Myocardial infarction within prior 6 weeks
- •Enrolled in another study
- •Recurrent sepsis or otherwise not a candidate for catheterization
- •Hypercoagulable state or inability to tolerate heparin therapy during procedure
- •Has had an atriotomy or ventriculotomy within prior 4 months
- •Life expectancy < 6 months
- •Class IV NYHA classification
研究组 & 干预措施
DSM
Active Comparator
Treatment using DSM to guide ablation
干预措施: Dynamic Substrate Mapping-guided ablation (Device)
结局指标
主要结局
Incidence of serious adverse events (SAEs)
时间窗: 30 days
次要结局
未报告次要终点
研究者
研究点 (3)
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