NCT02906189Unknown不适用
Safety of Magnetic Resonance Imaging in Non-MRI Conditional Pacemakers and ICD Devices
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Death during the MRI scan
研究概览
简要总结
The primary objective of the study is to determine the safety of MRI in patients with non-MRI conditional pacemakers. The secondary objective is to determine if there are clinically relevant parameter changes in the devices.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Death during the MRI scan
时间窗: Immediate
次要结局
- Decrease in battery voltage >0.04v(6 months)
- Change in pacing lead impedance ≥ 50 Ω(6 months)
- Change in high-voltage lead impedance ≥ 3 Ω(6 months)
- Increase in pacing threshold ≥ 0.50 V @ 0.4 ms(6 months)
- Decrease in P wave measurement ≥ 50%(6 months)
- Decrease in R wave measurement ≥ 25%(6 months)
- Generator failure requiring immediate replacement(Immediate)
- Lead failure requiring immediate replacement(Immediate)
- New onset atrial or ventricular arrhythmia during MRI(Immediate)
- Loss of pacemaker capture during MRI(Immediate)
- Electrical reset of the device(Immediate)
研究者
Michael Morris
Clinical Assistant Professor
Banner Health
研究点 (1)
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