NCT00187239已完成4 期
Reduce Ventricular Pacing in Dual Chamber Implantable Cardioverter Defibrillators Using AutoIntrinsic Conduction Search (REDUCE Study)
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- The primary endpoint is the percentage of intrinsic ventricular events.
研究概览
简要总结
The purpose of this study is to determine if patients implanted with a St. Jude Medical (SJM) implantable cardioverter defibrillator (ICD) will benefit by using AutoIntrinsic Conduction Search (AICS) rather than only a programmed AV/PV delay. This study will compare the two methods of programming with respect to intrinsic activity.
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
- •Patient has been implanted with a dual chamber SJM ICD with AICS for 1 month (± 2 weeks).
- •At the time of enrollment, patient is paced in the right ventricle (RV) ≤25% of the time as determined by the device diagnostics.
- •Patient is medically stable.
排除标准
- •Patient has evidence of atrioventricular (AV) block (first, second or third degree) such that ventricular pacing would be required as part of the patient's routine management
- •Patient is unable to comply with the follow-up visits due to geographical, psychological, or any other reasons.
- •Patient is younger than 18 years of age.
- •Patient is pregnant.
研究组 & 干预措施
AICS Off
No Intervention
Patients assigned to this arm do not have Autointrinsic Conduction Search programmed on.
AICS On
Active Comparator
Patients in this arm have Autointrinsic conduction search programmed ON.
干预措施: Autointrinsic Conduction Search Algorithm (Device)
结局指标
主要结局
The primary endpoint is the percentage of intrinsic ventricular events.
时间窗: 3 months
次要结局
- Study related adverse events(3 months)
- Number of atrial tachycardia (AT), atrial fibrillation (AF), ventricular tachycardia (VT), and ventricular fibrillation (VF) episodes(3 months)
- Frequency of inappropriate ICD therapy during AT/AF(3 months)
- Frequency of appropriate ICD therapy for VT/VF(3 months)
研究者
研究点 (1)
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