Prospective Comparison of 50/50% Tilt and Tuned Defibrillation Waveforms in Right-Sided Implants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- True Design for Test (DFTs) in fixed tilt and tuned waveforms obtained in volts (V)
研究概览
简要总结
The purpose of this study is to compare the defibrillation efficacy between the 50/50% tilt biphasic waveform and the Tuned biphasic waveform in patients with right-sided implants.
详细描述
Current era implantable cardioverter defibrillators (ICDs) have high defibrillation efficacy. This has stimulated a debate about whether DFT testing should be performed at all.1-3 However, this dialog has primarily centered around left sided implants, a group that is characterized by a small incidence of high defibrillation thresholds (DFTs).
The mechanism of phase duration programming to improve DFTs would seem to be most effectively applied to a group of patients with a high incidence of high DFTs such as right sided implants. This study therefore aims to prospectively evaluate direct phase duration programming on DFTs in right sided implants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient meets standard indication for an ICD/ CRT-D
- •Patient will be implanted with an FDA approved SJM ICD/ CRT-D that has a higher capacitance (maximum delivered energy - 36 J)
- •Pulse generator will be implanted on the right-side
- •Patient is able to tolerate DFT testing.
- •RV lead will be placed in the RV apex or inferior septum
排除标准
- •Patient is pregnant.
- •Patient is less than 18 years old.
- •SVC coil was turned ON during DFT testing
结局指标
主要结局
True Design for Test (DFTs) in fixed tilt and tuned waveforms obtained in volts (V)
时间窗: Baseline
次要结局
- True DFTs in fixed tilt and tuned waveforms obtained in joules (J)(Baseline)