University Hospital Cardiac Device MR Registry: The Safety of MR Imaging in Patients With Implanted Cardiac Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Battery voltage
研究概览
简要总结
A single-center registry to prospectively evaluate the safety of non-cardiac/non-thoracic magnetic resonance imaging (MRI) in patients with implanted cardiac devices (pacemakers and implantable cardioverter defibrillators).
详细描述
Evaluation of safety of MR scanning of patients with implanted cardiac devices. Device parameters pre and post MR imaging will be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female 18 years or older
- •Informed consent can be provided by patient or medical power of attorney
- •Presence of implanted pacemaker or ICD
- •MRI is the diagnostic modality of choice for a specific clinical scenario without acceptable alternative imaging technology as determined by ordering physician
- •Non-cardiac/non-thoracic MRI ordered
排除标准
- •Presence of metallic objects that represent a contraindication to MR imaging
- •Morbid obesity which results in body contact with the magnet façade
- •Pacemaker or ICD generator implanted prior to 2002
- •ICD patients who are pacing dependent
- •Pregnancy
- •Device generator at ERI (elective replacement interval)
- •Presence of other active implanted medical device
- •Presence of abandoned leads (with the exception of post CABG temporary epicardial pacing wires)
- •Presence of implanted cardiac device in the abdominal position
- •Pacemaker or ICD that is labeled as MRI-Conditional by the FDA
- •Pacemaker or ICD implanted less than 6 weeks prior to MRI scan
结局指标
主要结局
Battery voltage
时间窗: Immediate
Change in voltage \> 0.04 V
Pacing lead impedance
时间窗: Immediate
Change in impedance \> 50 Ohms
Shock impedance
时间窗: Immediate
Change in impedance \> 3 Ohms
P wave amplitude
时间窗: Immediate
Decrease in amplitude \> 50%
R wave amplitude
时间窗: Immediate
Decrease in amplitude \> 25%
Pacing lead threshold
时间窗: Immediate
Threshold increase \> 0.5 V at a fixed pulse width of 0.4ms
Adverse event
时间窗: Immediate
An adverse clinical event
次要结局
未报告次要终点
研究者
Patrick Aquilina
Physician, Division of Cardiac Electrophysiology
University Health Care System, Augusta, Georgia