适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Medtronic
- 入组人数
- 2,483
- 主要终点
- MRI Related Complication Rate
研究概览
简要总结
The purpose of this Post-Approval Study (PAS) is to demonstrate the chronic performance of the SureScan pacing system when used in an MRI environment according to product labeling. This study is required by the Food and Drug Administration (FDA) as a condition of product approval.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
- •Subject is or intended to be implanted with a complete SureScan pacing system consisting of both a right atrial and ventricular 5086MRI Lead (used for pacing and sensing) and a SureScan device
- •Subject within 30 days of implant (maximum 50% of Chronic Performance Arm enrollment) or subject enrolled into Multiple MRI Scan Arm at the time of MRI scan indication
排除标准
- •Subject who is, or will be inaccessible for follow-up
- •Implant and follow-up data, including adverse device effects and system modifications at implant through the time of enrollment are unavailable
- •Subject with exclusion criteria required by local law
结局指标
主要结局
MRI Related Complication Rate
时间窗: 5 years
Lead Related Complication Rate
时间窗: 5 years
次要结局
- Assess change in pacing thresholds after multiple MRI scans(5 years)
- Summarize MRI system and scan conditions(5 years)
- Pacing system related events(5 years)
- Characterize lead impedance(5 years)
研究者
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