CTRI/2016/12/007612已完成4 期
A post-market clinical evaluation of St. Jude Medicalâ?¢ MR Conditional ICD System on patients undergoing Magnetic Resonance Imaging
St Jude Medical India Ltd0 个研究点目标入组 171 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 171
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •To participate in this clinical investigation, the subject must meet all of the following inclusion criteria:
- •1. Subject is pectorally implanted with St. Jude Medical• MR Conditional ICD System for at least 60 days
- •2. 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
- •3. Subjectâ??s ventricular bipolar capture threshold is stable < 2.5V @ 0.5ms
- •4. Subjectâ??s ventricular sensing is measurable (patient has underlying rhythm > 30bpm) and the sensing amplitude is stable > 4mV
- •5. Subject is able to provide informed consent for study participation (legal guardian or legally authorized representative is NOT acceptable)
- •6. Subject is willing and able to comply with the prescribed follow-up tests and procedures
- •7. Subject is not contraindicated for an MRI scan (per the MRI Screening Form)
排除标准
- •To participate in this clinical investigation, the subject must meet none of the following exclusion criteria:
- •1. Subject is pacemaker dependent
- •2. Subject has a non SJM MRI compatible endocardial lead implanted or capped
- •3. 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.
- •4. Subject has a high voltage lead revision incidence < 60 days of the enrollment visit
- •5. 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
- •6. Subject has a lead extender, adaptor, or capped/abandoned lead
- •7. 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.
- •8. Subject is pregnant or planning to become pregnant during the duration of the subjectâ??s participation in the study
- •9. Subject has a life expectancy of less than 12 months due to any condition
- •10. Subject has exclusion criteria required by local law (e.g., age)
研究者
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