NCT01076374已完成不适用
Medtronic Adapta/Versa/Sensia Long Term Reliability 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
- 2,927
- 主要终点
- Rate of device malfunctions
研究概览
简要总结
The primary purpose of this study is to assess the long term reliability of the Medtronic Adapta®/Sensia™/Versa™ platform of devices. This study is required by FDA as a condition of approval of nEw3 devices. Patients will be followed for 5 years after implant. This study utilizes data collected from the System Longevity Study (SLS).
详细描述
The rate of device malfunctions will be determined and a comparison to historical controls will be done.
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
- •Subjects or appropriate legal guardians provide written informed consent and/or authorization for access to and use of health information, as required by an institution's IRB/MEC/REB.
- •AND one of the following must also apply:
- •Subjects indicated for implant or within six months post-implant of a Medtronic market-released lead connected to a Medtronic Adapta®, Sensia™, or Versa™ IPG. The Medtronic lead must be used for pacing, sensing or defibrillation application.
- •Subjects who participated in a qualifying study (IDE) of a Medtronic cardiac therapy product and: 1) have a Medtronic Adapta®, Sensia™, or Versa™ IPG 2)product is market-released 3) complete implant and follow-up data, including product-related adverse events are available and 4) subject of appropriate legal guardian authorizes release of subject study data to SLS
- •Subjects implanted with a Medtronic Adapta®, Sensia™, or Versa™ IPG and Medtronic CapSure Epi Leads (model 4965 and 4968) at a minimum of three pre-selected sites to retrospectively collect data for post approval requirements.
排除标准
- •Subjects who are, or will be inaccessible for follow-up at a SLS center
- •Subjects with exclusion criteria required by local law (EMEA only)
- •Subjects receiving an implant of a Medtronic device at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant
- •Subjects implanted with a Medtronic device whose predetermined enrollment limit for that specific product has been exceeded
结局指标
主要结局
Rate of device malfunctions
时间窗: 5 years
次要结局
未报告次要终点
研究者
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