NCT02096692已完成不适用
ProMRI Study of the Iforia ICD System (Phase C)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 主要终点
- MRI and ICD System Related Serious Adverse Device Effect (SADE) Free Rate
研究概览
简要总结
The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI ICD System when used under specific MRI conditions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •The following initial inclusion criteria must be met for a subject to be enrolled and considered for the MRI-procedure:
- •Age greater than or equal to 18 years
- •Able and willing to complete MRI testing
- •Able to provide written informed consent
- •Available for follow-up visit at the study site
- •Implanted with an ICD System consisting only of an Iforia DR-T and Linoxsmart S 65 / Linoxsmart SD 65/18 with Setrox S 53 atrial lead or Iforia VR-T DX and Linoxsmart S DX 65/15 or Linoxsmart S DX 65/
- •ICD implanted pectorally
- •All ICD system components implanted, repositioned, or exchanged at least 5 weeks prior to enrollment
- •Underlying rhythm identifiable during sensing test
- •All pacing thresholds are measureable and are less than or equal to 2.0 V @ 0.4 ms (Criterion does not apply to atrial pacing threshold for subjects with an Iforia DR-T that have AF and are permanently programmed to VVI and for subjects with an Iforia VR-T DX)
- •Ventricular sensing is measurable and >6.5mV
- •Absence of phrenic nerve stimulation at 5.0V and 1.0 ms
- •Pacing impedance is between 200 and 1500 ohm
- •Shock Impedance is between 30 and 90 ohm
- •Able and willing to use the CardioMessenger II
- •At the pre-MRI procedure, the following procedure-related criteria must be met for the subject to undergo the MRI scan:
- •Absence of phrenic nerve stimulation at 5.0V @ 1.0 ms
- •|pacing threshold at Pre-MRI follow-up - pacing threshold at baseline| ≤ 0.5 V (ICD Lead Only)
- •All pacing thresholds are measureable and are less than or equal to 2.0 V @ 0.4 ms (Criterion does not apply to atrial pacing threshold for subjects with an Iforia DR-T that have AF and are permanently programmed to VVI and for subjects with an Iforia VR-T DX.)
- •Ventricular sensing is measurable and >6.5mV
- •The ICD system has been implanted for at least six weeks.
- •Subject did not have an ICD or lead explant, exchange or reposition in the previous 6 weeks.
- •All lead pacing impedances are between 200 and 1500 ohm
- •Shock impedance is between 30 and 90 ohm
- •Battery status is at least 30% of capacity
排除标准
- 未提供
结局指标
主要结局
MRI and ICD System Related Serious Adverse Device Effect (SADE) Free Rate
时间窗: 1 Month Post-MRI
Percentage of Participants Free of Ventricular Pacing Threshold Rise
时间窗: Between Pre-MRI and 1 Month Post-MRI
Evaluate the percentage of ICD leads free of ventricular pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.
Percentage of Participants Free of R-wave Sensing Attenuation
时间窗: Between Pre-MRI and 1 Month Post-MRI
Evaluate the percentage of subjects free of R-wave attenuation between the Pre-MRI and one-month post-MRI follow-up.
次要结局
未报告次要终点
研究者
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