A Single Institution Registry Trial Evaluating the Safety of MRI for Patients With Non-MRI Conditional Pacemakers and ICD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 262
- 试验地点
- 1
- 主要终点
- Number of Participants With Potentially Lethal/Previously Non-diagnosed Arrhythmias During MRI
研究概览
简要总结
The purpose of the registry is to accumulate pre-and post-scan device interrogation data for the purpose of determining the risk of MRI for patients with implantable devices.
详细描述
Registry Purpose
This registry is a prospective single institution study of MRI examinations in patients with pacemakers or ICD's who will undergo an MRI that is ordered for routine clinical care. The purpose of the registry is to accumulate pre-and post-scan device interrogation data for the purpose of determining the risk of MRI for patients with implantable devices.
Registry data will add to existing data on the safety of MRI scans for patients with pacemakers and ICDs. This safety data may impact physicians' diagnostic choices for this patient population. Patients with conditions for whom MRI is the best diagnostic modality but who have not been able to undergo MRI scanning may be able to do so through registry participation. The diagnostic information obtained from the scan may assist physicians' treatment decisions and may ultimately affect patient outcomes.
In addition, to our knowledge, previous registries of MRI's in non-conditional cardiac devices have been limited to academic centers. This registry would be among the first to demonstrate the feasibility and safety of this approach in a community hospital setting.
Study Methods
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 否
入选标准
- 未提供
排除标准
- •Non-device related contraindication for MRI (such as implanted metallic objects, claustrophobia, morbid obesity)
- •Presence of capped/abandoned/epicardial leads or subcutaneous coil
- •Device generator at elective replacement interval
- •Abdominal device implant
结局指标
主要结局
Number of Participants With Potentially Lethal/Previously Non-diagnosed Arrhythmias During MRI
时间窗: Through procedure completion, an average of 1 hour
Number of Participants With Serious Injury/Death Related to MRI Device Malfunction/Failure
时间窗: Through procedure completion, an average of 1 hour
Number of Participants With Spontaneous and Unanticipated Pacing Rate Change
时间窗: Through procedure completion, an average of 1 hour
Number of MRI Scans With Post-MRI Device Parameter Change: Greater Than 50 Ohm Change in Atrial or Ventricular (RV and/or LV) Lead Impedance
时间窗: Through procedure completion, an average of 1 hour
Number of Participants With Burning or Pulling Sensations in Chest/Device Pocket During MRI
时间窗: Through procedure completion, an average of 1 hour
Number of Participants With MRI Related Device Malfunction/Failure
时间窗: Through procedure completion, an average of 1 hour
Number of MRI Scans With Post-MRI Device Parameter Changes: Greater Than 50% Decrease in Atrial or Ventricular (RV and/or LV) Sensing Threshold
时间窗: Through procedure completion, an average of 1 hour
Number of MRI Scans With Post-MRI Device Parameter Changes: Greater Than or Equal to a 1 Volt Increase in Atrial or Ventricular (RV and/or LV) Pacing Threshold
时间窗: Through procedure completion, an average of 1 hour
Number of Participants With Power on Reset of Pacemaker or ICD
时间窗: Through procedure completion, an average of 1 hour
Number of MRI Scans With Post-MRI Device Parameter Changes: Greater Than 5 Ohm Change in High Voltage Lead Impedance
时间窗: Through procedure completion, an average of 1 hour
次要结局
未报告次要终点