NCT00949000已完成不适用
Clinical Evaluation of ST Segment Deviation Detection by SJM AnalyST and Analyst Accel Implantable Cardiac Defibrillators
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- Evaluation of ST segment deviations during stress testing across the 4 heart rate zones defined by the device
研究概览
简要总结
The objective of the study is to collect information on the naturally occurring variations in ST deviations at different heart rates, as detected by the AnalyST and AnalyST Accel Implantable Cardioverter Defibrillators (ICD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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 received or is scheduled to receive a St Jude Medical AnalyST or AnalyST Accel ICD;
- •Patient has documented ischemic heart disease.
排除标准
- •Patient has an indication for ventricular pacing;
- •Patient has chronotropic incompetence or insufficiency;
- •Patient has a contraindication to stress testing;
- •Patient is physically unable to complete the stress test protocol;
- •The patient has persistent or permanent atrial fibrillation (AF);
- •Patient is unable to comply with the protocol and follow-up schedule based on geographic location or for any reason;
- •Patient is pregnant;
- •Patient is minor (< 18 years old).
研究组 & 干预措施
ICD Implant
Other
Implantation of a commercially available AnalyST or AnalyST Accel ICD
干预措施: ICD Implantation (Device)
结局指标
主要结局
Evaluation of ST segment deviations during stress testing across the 4 heart rate zones defined by the device
时间窗: 4 weeks
Evaluation of start and duration of isoelectric PR intervals
时间窗: 4 weeks
Evaluation of start and duration of ST intervals
时间窗: 4 weeks
Incidence of ischemic events detected based on the external ECG
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
研究点 (5)
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