A Clinical Evaluation of the Diagnostic Utility of MRI Scans in Patients Implanted With St. Jude Medical Pacemakers, Implantable Cardioverter Defibrillator, and Cardiac Resynchronization Therapy Devices.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 116
- 主要终点
- The Proportion of MRI Scans From Pacemakers or CRT-Ps Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation.
研究概览
简要总结
This study is a prospective, non-randomized, multi-center study of subjects implanted with an SJM pacemakers, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices who are clinically indicated for a non-thoracic MRI scan.
详细描述
This study will be performed as part of a regulated, prospective, non-randomized, multi-center clinical study.
Subjects will be enrolled, undergo a clinically-indicated MRI scan, and have an assessment of adverse events, device measurements, and clinical utility of the MRI scan images.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •Patient is implanted with a market-released St. Jude Medical pacemaker, ICD, or CRT current generation device listed in the study protocol and any market-released pacing or defibrillation lead.
- •Patient's device and all leads must be implanted for at least 6 weeks prior to the scheduled date of the MRI.
- •Patient has a clinical indication for a non-thoracic MRI scan, where MRI is the imaging modality of choice that will give adequate results to manage the patient.
- •Patient is scheduled for a non-thoracic MRI scan up to 1.5T.
- •Patient has a pacemaker, ICD, or CRT device implanted pectorally.
- •Patient has the ability to provide informed consent for study participation and be willing and able to comply with the study procedures.
- •Patient is 18 years or above, or of legal age to give informed consent specific to state and national law.
排除标准
- •Patient has an ICD/CRT-D and is pacemaker dependent
- •Capture threshold is greater than 2.5 volts at 0.5 ms for RA and RV leads
- •Pacing lead impedance is NOT within range (i.e. ≥ 200 and ≤ 2000 ohms)
- •High voltage lead impedance (HVLI) is NOT within range (i.e. ≥ 20 and ≤ 200 ohms)
- •Patient has a device generator battery voltage at elective replacement interval (ERI)
- •Patient has another existing active implanted medical device (e.g. neurostimulator, infusion pump, etc.) that has MR labeling that will not allow the MRI scans to be completed.
- •Patient has other non-MRI compatible device or material implanted
- •MRI compatible knee replacements, hip replacements, stents, etc. may be included as long as the labeling of these devices allow MRI scans conducted per this protocol
- •MRI compatible mechanical, prosthetic, and bioprosthetic heart valves may be included as long as the labeling of these devices allow for MRI scans conducted per this protocol
- •Non-removable dental implants may be included
- •Patient has a lead extender, adaptor, or capped/abandoned lead
- •Patient is pregnant
研究组 & 干预措施
Pacemaker, ICD, or CRT device patients
Subjects who need a non-thoracic clinically indicated scan
干预措施: Pacemaker, ICD, or CRT device (Device)
结局指标
主要结局
The Proportion of MRI Scans From Pacemakers or CRT-Ps Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation.
时间窗: 1 month
Based on the ability of the radiologist to read and provide a diagnosis/report.
The Proportion of MRI Scans From ICDs or CRT-Ds Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation.
时间窗: 1 month
Based on the ability of the radiologist to read and provide a diagnosis/report.
次要结局
未报告次要终点