Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,013
- 试验地点
- 139
- 主要终点
- Patients With Inappropriate Shock(s)
研究概览
简要总结
ISIS- ICD study has been designed to evaluate the impact of PARAD+ algorithm on inappropriate shocks, in a general population implanted for primary or secondary prevention with a dual or tri chamber device at one year follow-up
详细描述
The primary endpoint is to demonstrate that 95% of patients implanted with PARAD+ algorithm are free from inapproporiate shock compared to 92.5% in general ICD population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient eligible for implantation (according to current accepted guidelines, or scheduled for implant (primo-implant, replacement, upgrade) with a Paradym/Paradym RF (CRT-D or DR-ICD) within the next 30 days, or has already been implanted within the last 30 days
- •Patient in sinus rhythm, or patients with paroxysmal atrial tachyarrhythmia or patients with persistent atrial tachyarrhythmia in whom a cardioversion is planned within three months
排除标准
- •Any contraindication for ICD therapy
- •Atrial lead not implanted
- •Patient with permanent atrial tachyarrhythmia
- •Patients implanted with a ventricular assist device (VAD)
研究组 & 干预措施
ICD or CRT-D with PARAD+
only 1 arm is the study: all patients implanted with ICD or CRT-D with PARAD+ enabled, no comparator
干预措施: PARADYM DR model 8550; PARADYM CRT model 8750; PARADYM RF DR model 9550; PARADYM RF CRT model 9750; PARADYM RF CRT SonR model 9770 (Device)
结局指标
主要结局
Patients With Inappropriate Shock(s)
时间窗: 552 days
Percentage of patients presenting with inappropriate shock(s)
次要结局
- Shock(s) Appropriately Delivered(552 days)