NCT01615835已完成不适用
Mapping in the Coronary Sinus During Implant of a Bi-Ventricular Implantable Cardioverter Defibrillator Utilizing the NavX Mapping System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Determine feasibility of CS mapping with EnSite NavX during CRT implant
研究概览
简要总结
Use of the EnSite NavX system to map the coronary vasculature during CRT implant
详细描述
Objective(s):
To determine the feasibility of CS mapping with NavX during Biventricular Implantable Cardioverter Defibrillator (BiV ICD) implantation.
Inclusion Criteria:
- Subject is between the age of 18 and 75 years
- Subject is willing and able to sign a study specific informed consent
- Subject is able to fulfill study requirements
- Meet the conventional criteria for implant of a BiV ICD, including; LVEF of ≤35%, QRS ≥ 120 ms and NYHA III-IV
- Have persistent CHF symptoms despite contemporary CHF medical therapy
- Stable and optimal medical therapy (stability is no changes in past 3 months).
- Documented history of ischemic or non-ischemic cardiomyopathy.
Exclusion Criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet criteria for CRT implant including EF<35%, QRS>120ms, NYHA class III or IV
- •Persistent CHF symptoms despite optimization
- •Stable/optimal medical therapy
- •History of ischemic or non-ischemic cardiomyopathy
排除标准
- •Any standard device exclusion including TVR
- •Positive pregnancy test
- •Currently participating in IDE/IND study
结局指标
主要结局
Determine feasibility of CS mapping with EnSite NavX during CRT implant
时间窗: Procedural
次要结局
未报告次要终点
研究者
研究点 (4)
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