Magnetic Resonance Imaging Safety in Patients With Non-Conditional, Mixed-Manufacturer Cardiac Implantable Electronic Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Evaluation of Changes in Device Battery Voltage (Volts)
研究概览
简要总结
This study is looking at the safety and efficacy of using MRIs with patients who have cardiac implantable electronic devices.
详细描述
Magnetic resonance imaging (MRI) is a critical diagnostic tool known for its non-invasive nature and high-resolution imaging capabilities. However, its safety in patients with cardiac implantable electronic devices (CIEDs), particularly those with mixed-lead systems, remains a significant clinical concern. This report investigates the safety and efficacy of MRI in such patients, where generators and leads originate from different manufacturers and are not officially deemed MRI-conditional.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •have a mixed-lead CIED
- •clinical relevant MRI
排除标准
- •same manufactured CIED
结局指标
主要结局
Evaluation of Changes in Device Battery Voltage (Volts)
时间窗: Immediately Prior to MRI and Immediately after MRI
report Device Battery Voltage (in Volts) prior to the MRI and after the MRI and determine if there was a change in voltage greater than 10% from the initial measurement to the final measurement.
Evaluation of Changes in Lead Impedance (Ohms)
时间窗: Immediately Prior to MRI and Immediately after MRI
report lead impedance (in Ohms) prior to the MRI and after the MRI and determine if there is a change in impedence greater than 20% from the initial measurement to the final measurement.
Evaluation of Changes in Lead Threshold (Voltage) Before and After MRI
时间窗: Immediately Prior to MRI and Immediately after MRI
report lead threshold in (voltage) prior to MRI and after the MRI and determine if there is a change greater than10% from the initial measurement to the final measurement.
次要结局
- Evaluation of Changes in Patient Clinical Outcomes (Rhythm, Symptoms, Cardiac Arrest, or Death) Before and After MRI(Immediately Prior to MRI and Immediately after MRI)
研究者
Ryka Tashakkor
First Author
Socal Heart