CTRI/2017/05/008447已完成不适用
Clinical Study to Confirm MRI Safety and Effectiveness Using SJM Cardiac Rhythm Management Systems
St Jude Medical India Ltd3 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2017年1月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 3
- 主要终点
- Freedom from MRI scan-related complications: one month following the MRI scan.
研究概览
简要总结
This is a prospective, multi-center clinical study designed to confirm the safety and effectiveness of St. Jude Medical low voltage pacemakers, high voltage dual chamber ICDs, and CRT-Ds with various leads in an MRI environment.
Total of 119 subjects enrolled across 14 investigational sites. The total duration of the study is 14 months. All Subjects were followed for 1 month following the MRI scan.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Eligible subjects will meet all of the following: • Are implanted with one of the following SJM device/lead combinations evaluated in this study for at least 60 days (can include patients with an eligible SJM lead for ≥ 60 days OR patients with a new eligible SJM pacemaker, ICD, or CRT device and eligible SJM lead implanted for at least 60 days:
- •Accent MRIâ„¢, Assurity MRIâ„¢, Endurity MRIâ„¢, or Endurity pacemaker with Tendrilâ„¢ STS Model 2088 lead
- •Accent MRIâ„¢, Assurity MRIâ„¢, Endurity MRIâ„¢, or Endurity pacemaker with IsoFlexâ„¢ Optim (Model 1944 or 1948) lead
- •Ellipseâ„¢ VR/DR or Fortify Assura VR/DR ICD with Tendrilâ„¢ STS (Model 2088) or Tendril MRIâ„¢ and Durataâ„¢ or Optisureâ„¢ leads
- •Quadra Assuraâ„¢ CRT-D with Tendrilâ„¢ STS (Model 2088), Durataâ„¢ or Optisureâ„¢, and Quartetâ„¢ Quadripolar leads • Are implanted with an eligible SJM pacemaker, ICD, or CRT-D device pectorally • Be willing to undergo an elective MRI scan without sedation.
- •Note: Antianxiety agents (e.g. minor tranquilizers, etc.) may be used as long as the subject can communicate with site personnel during the MRI scan • Be able to provide informed consent for study participation (legal guardian is NOT acceptable) • Be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
排除标准
- •Subjects will be excluded if they meet any of the following: • Have 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.
- •â€¢ Have other non-MRI compatible device or material implanted o 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 o 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 o NOTE: Non-removable dental implants may be included • Have a lead extender, adaptor, or capped/abandoned lead • Be unable to fit in MRI bore, i.e., subject will come into contact with the magnet façade inside the MRI bore.
- •â€¢ Are currently participating in a clinical investigation that includes an active treatment arm • Are pregnant or planning to become pregnant during the duration of the study • Have a life expectancy of less than 3 months due to any condition • Meet exclusion criteria per local law (e.g. age).
结局指标
主要结局
Freedom from MRI scan-related complications: one month following the MRI scan.
时间窗: one month post MRI scan
次要结局
- Proportion of subjects with a capture threshold increase of less than 0.5V at 0.5 ms from pre MRI scan to one month post MRI scan(one month post MRI scan)
研究者
研究点 (3)
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