NCT01638897已完成不适用
DF4 Connector System Post-Approval Study
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
- 1,778
- 主要终点
- DF4 Lead Related Complication Rate
研究概览
简要总结
The purpose of this study is to evaluate long-term performance of the DF4 Connector System. This evaluation is based on the number of DF4 lead-related complications occurring during the study compared to the number of leads enrolled in the study. The DF4 systems will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the DF4 Connector Systems. This study is conducted within Medtronic's post-market surveillance platform.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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 intended to be implanted or is within 30 days post-implant of a DF4 Connector System with a Medtronic DF4 lead used for a pacing, sensing and/or defibrillation application
排除标准
- •Subject who is, or will be inaccessible for follow-up at a study site
- •Subject with exclusion criteria required by local law (Europe, Central Asia [ECA] only)
- •Implant and follow-up data, including any adverse device effects and system modifications at implant through the time of enrollment are unavailable
结局指标
主要结局
DF4 Lead Related Complication Rate
时间窗: Up to 5 Years
To demonstrate that the complication-free probability is greater than 92.5% at five years post-implant for the high voltage DF4 lead
次要结局
- Types of DF4 lead related events(Up to 5 years)
- Bipolar pacing impedance (ohms)(5 years)
- High voltage impedance (ohms)(5 years)
- Pacing threshold (volts)(5 years)
- Sensing amplitude (millivolts)(5 years)
研究者
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