NCT00180297已完成不适用
Evaluation of the Success Rate and the Clinical Evolution of a Ventricular Lead Implanted in the Septum Versus the Right Ventricular Apex.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 215
- 试验地点
- 35
- 主要终点
- Implant Success Rate at Septal Site
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of the implant of a ICD lead of defibrillation in the septum of the right ventricle
详细描述
The rate of success at implant and the positive clinical outcomes for the patients implanted with a lead of defibrillation at the septal site would make it possible to recommend this site as a "new standard" for implant of the defibrillation lead in the RV for ICD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •ICD indication according to current Guidelines
排除标准
- •Indication for cardiac resynchronisation therapy, absence of spontaneous ventricular rhythm, pacemaker dependency
结局指标
主要结局
Implant Success Rate at Septal Site
时间窗: At implant
Success of implant procedure: 1. implanted at the randomized site; 2. With electric criteria satisfied: pacing threshold \< 1.5V, intrinsic amplitude \>3 mV, impedance between 450 and 1800 Ω, shock impedance between 29 and 80 Ω and defibrillation at a maximum of 21J.
次要结局
- Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment(Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months)
- The Rate of ATP Success Therapy(3 months, 6 months, 12 months, 36 months, 60 months)
- - The Number of "Low Energy" Shocks (at 11 Joules), Efficient in the VT Zone, in the Population Programmed at This Recommended Value.(3 months, 6 months, 12 months, 36 months, 60 months)
- Evolution of Left Ventricular Ejection Fraction(12 Months)
- Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment(Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months)
研究者
研究点 (35)
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