Evaluating MRI Scanning in Patients With Fractured or Abandoned Endocardial Leads
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Incidence of Adverse Events related to Magnetic Resonance Imaging (MRI) in patients with abandoned or fractured pacemaker or implantable cardioverter defibrillator (ICD) leads
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of MRI scanning in patients with fractured or abandoned endocardial leads. Specifically, the investigators aim to provide community-acquired data that can be used in Medicare and Medicaid coverage determinations and to investigate whether patients with fractured or abandoned leads can safely be scanned using an MRI and to evaluate the impact of MRI availability on patient care in this population. This study also aims to validate similar studies conducted by Mayo Clinic, the Hospital of the University of Pennsylvania and Johns Hopkins Medicine that employ MRI in the abandoned lead patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence of Adverse Events related to Magnetic Resonance Imaging (MRI) in patients with abandoned or fractured pacemaker or implantable cardioverter defibrillator (ICD) leads
时间窗: 2 hours
Incidence of symptoms and adverse events related to Magnetic Resonance Imaging (MRI) in patients with abandoned or fractured pacemaker or implantable cardioverter defibrillator (ICD) leads. The following measures will be collected twice during the MRI scan and reported via patient questionnaire and reported observation by technologist and electrophysiology physician or advance practice provider. Proportion/percentage of participants with: 1. Pulling in pocket 2. Chest pain 3. Burning in pocket 4. Palpitations 5. Shortness of breath 6. Other Adverse Events - collected via device monitor after MRI scan. Proportion/percentage of participants with: 1. Atrial fibrillation 2. Ventricular arrhythmias 3. Frequent premature ventricular contractions with hemodynamic instability 4. Symptomatic bradycardia with heart rate less than 40 beats per minute
次要结局
- Understand longitudinal utilization and safety of subsequent MRIs(7 years)