Micra Transcatheter Pacing System Post-Approval Registry
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Medtronic
- 入组人数
- 3,100
- 试验地点
- 155
- 主要终点
- Acute complication rate
研究概览
简要总结
Medtronic is sponsoring the Micra Registry to further confirm safety and effectiveness of the Micra Transcatheter Pacing System (Micra system) when used as intended, in "real-world" clinical practice, following commercial release.
The Micra Registry is conducted within Medtronic's Product Surveillance Registry.
详细描述
The Micra Registry is a global, prospective, observational, multi-site registry. Patients enrolled in the Micra Registry will be prospectively followed for a minimum of 9 years post-implant or until registry closure, patient death, patient exit from the registry (i.e., withdrawal of consent), or unless patient is participating in an acute performance sub-study of the Micra Registry*.
Enrolled patients will have scheduled follow-up visits at least annually or as prompted by reportable adverse events; however, all Micra system follow-up patient visits are to be reported. Therefore, if more frequent scheduled visits occur per a provider's standard care practice, those visits are reported. The total estimated registry duration is 11 years.
*Patients contributing to an acute performance sub-study of the Micra Registry do not contribute to the FDA-regulated Post-Approval Study which includes a long-term (minimum 9-year) patient follow-up period.
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
- •Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
- •Patient is intended to receive or be treated with a Micra Transcatheter Pacing System and must be enrolled prior to the TPS implant procedure
排除标准
- •Patient who is, or is expected to be inaccessible for follow-up
- •Patient with exclusion criteria required by local law
- •Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
研究组 & 干预措施
Patients implanted with Micra System
Patients implanted with a Micra Transcatheter Pacing System are eligible for enrollment into the Micra PA Registry.
干预措施: Micra Transcatheter Pacing System (Device)
结局指标
主要结局
Acute complication rate
时间窗: 30-days
To estimate acute complication rate related to the Micra system and/or implant procedure.
Long-term complication free survival
时间窗: 9 years
To estimate the chronic complication free survival rate of the Micra system.
次要结局
- Estimate Micra System revision rate(Up to 9 years)
- Estimate System Longevity(Up to 9 years)
- Pacing impedance (ohms) and pacing threshold (volts)(Up to 9 years)
- Complications stratified by implant type(Up to 9 years)
- Confirm the rate response operation of the Micra system(Approximately 2 years)