A Clinical Evaluation of the Safety and Efficacy of St. Jude Medical (SJM) Magnetic Resonance Imaging (MRI) Conditional Pacing System in Patients Undergoing Cardiac MRI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 283
- 试验地点
- 13
- 主要终点
- Freedom From MRI Scan-related Complications
研究概览
简要总结
The aim of this study was to assess safety and efficacy of SJM MRI conditional pacing system. The study hypothesized that cardiac MRI scan would not affect performance of SJM MRI conditional pacing system.
详细描述
Accent Cardiac MRI study was a prospective, randomized ,multi-center study conducted in Asia. Subjects indicated for dual-chamber pacemaker and who signed study consent form were considered enrolled and post implant were randomized to either Cardiac MRI Scan Group or Control Group.
Clinical evaluation and device interrogation were performed at baseline, pre- and post-MRI scan, and one month post-MRI for all subjects. At 9-12 weeks post-implant, patients in Cardiac MRI Scan Group underwent an elective non-diagnostic cardiac MRI scan at 1.5 Tesla (T) while patients in Control group underwent device interrogation and clinical evaluation twice with a 45-minute waiting period in between. The safety endpoint was freedom from MRI-related complications while efficacy endpoint was change in right atrial/ ventricular (RA/RV) capture threshold and sensing amplitude from pre-MRI scan to one month post-MRI scan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Have an approved indication per American College of Cardiology(ACC)/ American Heart Association(AHA)/ Heart Rhythm Society(HRS)/ European Society of Cardiology(ESC) guidelines for implantation of a pacemaker
- •Will receive a new dual chamber pacemaker and leads
- •Be willing to undergo an elective MRI scan without complete sedation, that is ,under consciousness during MRI scan
- •Be able to provide informed consent for study participation
- •Be willing and able to comply with the prescribed follow-up tests and schedule of evaluations
- •Is not contraindicated for an MRI scan (per the pre-MRI safety screening form)
- •Age≥18 years
- •Subjects must be able to undergo pectoral implantation
排除标准
- •Having an existing pacemaker or Implantable Cardioverter Defibrillator (ICD) .A new pacemaker and lead is required for enrollment
- •Permanent Atrial Fibrillation/Flutter
- •Are medically indicated for an MRI scan at the time of enrollment
- •Have an existing active implanted medical device, e.g. neurostimulator, infusion pump etc
- •Have a non-MRI compatible device or material implanted
- •Have a lead extender or adaptor
- •Be unable to fit in MRI bore; will come into contact with the magnet façade inside the MRI bore
- •Are currently participating in a clinical investigation that includes an active treatment arm
- •Are allergic to dexamethasone sodium phosphate(DSP)
- •Are pregnant or planning to become pregnant during the duration of the study
- •Have a life expectancy of less than 12 months due to any condition
- •Subjects with exclusion criteria required by local law (e.g. age)
- •Are unable to comply with the follow up schedule
研究组 & 干预措施
Control Group
Cardiac MRI Scan Group
干预措施: Non-Diagnostic Cardiac MRI scan (Diagnostic Test)
结局指标
主要结局
Freedom From MRI Scan-related Complications
时间窗: MRI Visit ,1 Month Post MRI Visit
Number of subjects who were free from MRI scan-related complications
Change in Right Atrial (RA) Capture Threshold @0.5 Millisecond (ms) From Pre-MRI Scan to 1 Month After MRI Scan
时间窗: MRI Visit ,1 Month Post MRI Visit
Number of subjects who experienced an increase in RA capture threshold @ 0.5 ms at 1-Month post MRI scan visit ≤ 0.5 Volt (V) compared to pre-MRI scan value collected at MRI scan visit
Change in Right Ventricular (RV) Capture Threshold @0.5ms From Pre-MRI Scan to 1 Month After MRI Scan
时间窗: MRI Visit, 1 Month Post MRI Visit
Number of subjects who experienced an increase in RV capture threshold @ 0.5 ms at 1-Month post MRI scan visit ≤ 0.5 V compared to pre-MRI scan value collected at MRI scan visit
Change in RA Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan
时间窗: MRI Visit, 1 Month Post MRI Visit
Number of subjects who experienced a decrease in RA sensing amplitude ≤ 50% and at least 1.5 mV at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit
Change in RV Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan
时间窗: MRI Visit, 1 Month Post MRI Visit
Number of subjects who experienced a decrease in RV sensing amplitude ≤ 50% and at least 5 mV at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit
次要结局
未报告次要终点