Clinically Indicated Magnetic Resonance Imaging of Patients With Permanent Pacemakers (PPM) and Implantable Defibrillators (ICD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,509
- 试验地点
- 1
- 主要终点
- Device Malfunction
研究概览
简要总结
Patients with implanted cardiac devices who meet appropriate entrance criteria undergo clinically indicated Magnetic Resonance (MR) Imaging Studies using an established safety protocol.
详细描述
This prospective cohort study to use an established MRI device safety protocol to decrease the risk of clinically indicated MR imaging in patients with implantable cardiac devices. All devices will undergo a complete interrogation and testing of thresholds, sensing, battery voltage and impedances prior to and following imaging. Pre-MRI, devices will be programmed to setting that will ensure MRI safety. During imaging, patients will blood pressure, heart rate and O2 sat level will be monitored continuously.
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
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an emergent or absolute need for MR imaging and PPM or certain ICD's
排除标准
- •Pacemaker dependent patients with ICD's
- •Patients with other contraindication to MRI
结局指标
主要结局
Device Malfunction
时间窗: immediately post MRI (up to 2 hours) and long-term follow-up (up to 6 months)
Number of patients with change in device testing defined as a change in any of the following (impedance, battery life, p and r wave sensing and atrial and ventricular capture thresholds) not to exceed 50 percent from baseline
Patient Safety
时间窗: assessed during MRI and immediate post MRI (up to 2 hours)
Number of patients with change in vital signs including blood pressure, heart rate and pulse oximetry not to exceed 10 percent from baseline lead impedances as well as patient reports of any discomfort related to MRI)
次要结局
- Noise Artifacts as Assessed by the Number of Participants With a Greater Than a 50% Change in Lead Impedance(Immediately post MRI (up to 2 hours))