Medtronic CRDM Product Performance Report
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Medtronic
- 入组人数
- 20,000
- 试验地点
- 344
- 主要终点
- Lead related complications for each lead model.
研究概览
简要总结
The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival probabilities.
详细描述
All Medtronic market-released leads and all market-released IPG, ICD and CRT devices are eligible to be included in this study.
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 who meet the following inclusion criteria and do not meet any of the following
排除标准
- •are eligible for enrollment.
- •Inclusion Criteria:
- •Subject 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:
- •Subject is indicated for implant or within 30 days post-implant of at least one Medtronic market-released product used for a pacing, sensing or defibrillation application
- •Subjects who participated in a qualifying study (IDE) of a Medtronic market-released product with complete implant and follow-up data and subject or appropriate legal guardian authorizes release of subject study data
- •Exclusion Criteria:
- •Subjects who are, or will be inaccessible for follow-up
- •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
Lead related complications for each lead model.
时间窗: Ongoing: Implant to the cardiac lead is terminated from the study if the patient exit, patient death, or out-of-service (e.g. deactivated/inactive).
All follow-up visits will be utilized in the analyses. This is an observational study that does not have a statistically powered primary hypothesis. Therefore, a specific study sample size is not applicable.
次要结局
未报告次要终点