A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 29
- 主要终点
- Number of Participants With Freedom From MRI-scan Related Complications* Related to St. Jude Medical™ MR Conditional ICD System
研究概览
简要总结
To assess the clinical performance of the St. Jude Medical™ MR Conditional ICD System in patients undergoing an elective thoracic MRI scan.
详细描述
This clinical investigation is a prospective, multicenter, Asian study. The study was designed with two (2) parts, however only the 1st part was completed. For the 1st part, patients were enrolled with a SJM MR Conditional ICD System approved for thoracic scan with 1.5 Tesla MRI scanning machines. The 2nd part-meant to enroll patients for thoracic scans with 3 Tesla MRI scanning machines-was not completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Subject is pectorally implanted with St. Jude Medical™ MR Conditional ICD System for at least 60 days
- •Subject is willing to undergo an elective MRI scan without sedation NOTE: Antianxiety agents (e.g. minor tranquilizers, etc.) may be used as long as the patient can communicate with site personnel during the MRI scan
- •Subject's ventricular bipolar capture threshold is stable < 2.5V @ 0.5ms
- •Subject's ventricular sensing is measurable (patient has underlying rhythm > 30bpm) and the sensing amplitude is stable > 4mV
- •Subject is able to provide informed consent for study participation (legal guardian or legally authorized representative is NOT acceptable)
- •Subject is willing and able to comply with the prescribed follow-up tests and procedures
- •Subject is not contraindicated for an MRI scan (per the MRI Screening Form)
排除标准
- •Subject is pacemaker dependent
- •Subject has a non SJM MRI compatible endocardial lead implanted or capped
- •Subject has another existing active implanted medical device, e.g., neurostimulator, infusion pump, etc. that has MR labeling that will not allow the MRI scans per this protocol to be completed.
- •Subject has a high voltage lead revision incidence < 60 days of the enrollment visit
- •Subject has other non-MRI compatible device or material implanted NOTE: 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 NOTE: 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 NOTE: Non-removable dental implants may be included
- •Subject has a lead extender, adaptor, or capped/abandoned lead
- •Subject is enrolled or intend to participate in a clinical drug and/or device study (investigational device, investigational drug, new indication for a device or drug or additional testing beyond standard of care procedures), which could confound the results of this trial as determined by SJM.
- •Subject is pregnant or planning to become pregnant during the duration of the subject's participation in the study
- •Subject has a life expectancy of less than 12 months due to any condition
- •Subject has exclusion criteria required by local law (e.g., age)
结局指标
主要结局
Number of Participants With Freedom From MRI-scan Related Complications* Related to St. Jude Medical™ MR Conditional ICD System
时间窗: from MRI scan visit to 1 month post-MRI scan visit
\*A complication is a serious adverse device effect (SADE) that requires an invasive intervention or leads to death. The primary endpoint analysis will be performed for each study phase separately.
次要结局
未报告次要终点