Shock Efficacy, a Randomized Study Comparing Fixed Tilt and Fixed Pulse Width in a General Implantable-Cardioverter Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 779
- 试验地点
- 2
- 主要终点
- Efficacy of the first appropriate shock to revert a tachyarrhythmia to sinus rhythm
研究概览
简要总结
This is a prospective, 1:1 randomized, interventional, multicenter and international trial. Approximately 790 subjects are expected to be enrolled to 40 sites in the south of Europe and Middle East.
详细描述
The objective of this study is to evaluate and compare the efficacy of the first appropriate shock of an ICD in a ventricular tachyarrhythmia, when the waveform of the shock is programmed with the standard waveform, Fixed Tilt with a value of 65% (Control Group), versus the exclusive waveform programmable in SJM ICDs, Fixed Pulse Width (Study Group), in a standard population of subjects with ICD indication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects who meet the current ESC indications for ICD or CRT-D implant. This includes upgrades indications from pacemaker to ICD or to CRT-D or replacements of ICDs or CRT-Ds provided that there is no previous record of ineffective shocks
- •Subjects who are willing to be registered on the Merlin.net remote follow-up program
- •Subject ≥18 years
- •Subjects with life expectancy of at least 1 year
- •Subjects who agree to comply with the follow-up program included in this protocol
排除标准
- •• Subjects on the waiting list for a heart transplant or under consideration for a transplant over the next 12 months
- •Subjects with Myocardial infarction or unstable angina within 40 days prior to enrollment
- •Subjects who have undergone a recent cardiac revascularization (PTCA, Stent or CABG) procedure in the 4 weeks prior to enrollment
- •Functional NYHA Class IV
- •Subjects who are participating in another ICD or CRT-D study
- •Subjects who are pregnant at the time of enrollment or women of childbearing potential that do not take contraceptives
- •Any disability or limitations to correctly understand or complete the study (physical, intellectual, logistical)
研究组 & 干预措施
Fixed Tilt (65%)
This is the control group, so device programming for shock energy is the default setting
干预措施: Fixed Tilt (65%) (Device)
Fixed Pulse Width
This is the Study group.
干预措施: Fixed Pulse Width (Device)
结局指标
主要结局
Efficacy of the first appropriate shock to revert a tachyarrhythmia to sinus rhythm
时间窗: 5 years
Rate of rhythm conversion from Ventricular Tachyarrhythmia to sinus rhythm by the first appropriate shock programmed to 25 Joules (or equivalent voltage) programming the shock waveform in Fixed Pulse Width (Study Group) versus the Fixed Tilt with value 65% (Control Group).
次要结局
未报告次要终点