A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing Magnetic Resonance Imaging, an Investigational Device Exemption (IDE) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 227
- 试验地点
- 32
- 主要终点
- Number of Participants With MRI Scan Related Complications
研究概览
简要总结
To demonstrate safety and efficacy of the Durata or Optisure high voltage lead and Ellipse VR ICD in an MRI environment.
详细描述
The intent of this IDE study is to evaluate the safety and efficacy of the Durata or Optisure lead and Ellipse VR ICD that have undergone an MRI scan. The patient population under study includes patients indicated for or who have been implanted with a Durata or Optisure lead and an Ellipse VR ICD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Are implanted with the Durata or Optisure lead for at least 60 days (can include patients with Durata or Optisure lead for > 60 days OR patients with a new Ellipse VR ICD and/or Durata/Optisure lead implanted for at least 60 days
- •Are implanted with an Ellipse VR ICD 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 patient can communicate with site personnel during the MRI scan
- •Capture threshold is stable < 2.5V @ 0.5ms
- •Ventricular sensing is measurable (patient has underlying rhythm > 30bpm) and the sensing amplitude is > 4mV
- •Be able to provide informed consent for study participation (legal guardian or legally authorized representative is NOT acceptable)
- •Be willing and able to comply with the prescribed follow-up tests and procedures
- •Are not contraindicated for an MRI scan (per the MRI Screening Form)
排除标准
- •Have a competitor's MRI compatible endocardial lead implanted or capped
- •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.
- •Have a lead revision of the Durata/Optisure lead occur < 60 days of the baseline visit
- •Have 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
- •Have a lead extender, adaptor, or capped/abandoned lead
- •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.
- •Pregnant or planning to become pregnant during the duration of the subject's participation in the study
- •Have a life expectancy of less than 12 months due to any condition
- •Patients with exclusion criteria required by local law (e.g., age)
结局指标
主要结局
Number of Participants With MRI Scan Related Complications
时间窗: MRI scan to 1 month post MRI scan
The primary safety endpoint is the number of participants that had an Ellipse ICD and/or a Durata or Optisure lead complication from the day the MRI scan occurred to the 1-month visit. A complication is defined as a serious adverse device effect that requires an invasive intervention or leads to death.
Percentage of Participants With Ventricular Capture Threshold ≤ to 0.5V
时间窗: pre-MRI scan to 1 month post MRI scan
Percentage of participants of Durata or Optisure (RV) leads implanted with the Ellipse VR ICD with capture threshold increase of ≤ 0.5V at 0.5ms from pre-MRI scan to 1 month post-MRI scan.
Percentage of Participants With Ventricular Sensing Amplitude Decrease of ≤ 50% From Pre-MRI Scan to 1 Month Post MRI Scan
时间窗: pre-MRI scan to 1 month post MRI scan
Percentage of Participants with Durata or Optisure RV leads implanted with the Ellipse VR ICD with sensing amplitude decrease of ≤ 50% from pre-MRI scan to 1 month post MRI scan.
次要结局
未报告次要终点