Lead Evaluation for Defibrillation and Reliability Post Approval Study (LEADR PAS)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Medtronic
- 入组人数
- 2,000
- 试验地点
- 84
- 主要终点
- Complication Survival Rate
研究概览
简要总结
Medtronic is sponsoring the LEADR PAS to provide continuing evaluation and periodic reporting of safety and effectiveness of the OmniaSecure™ defibrillation lead following commercial release. The LEADR PAS is conducted within Medtronic's Product Surveillance Registry Platform (NCT01524276).
详细描述
The LEADR PAS is a global, prospective, observational, multi-site registry study. This study is conducted within Medtronic's Product Surveillance Registry Platform (NCT01524276).
Eligibility for enrollment is based on market release dates for the OmniaSecure™ defibrillation lead within the geography in which the subject is enrolled.
Patients enrolled in LEADR PAS will be prospectively followed for the lifetime of device post-implant or until registry closure, patient death, or patient exit from the registry (i.e., withdrawal of consent).
Successfully implanted patients are expected to have scheduled follow-up visits per routine clinical care, at least annually, or as prompted by reportable adverse events. The primary objective analysis will occur when 500 patients reach 5 years of follow-up. The total estimated registry duration is through lifetime of device.
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 has, or is intended to receive or be treated with an OmniaSecure™ defibrillation lead.
- •Patient is consented prior to or within 30 days of the therapy received or consented as continuation from the LEADR Pivotal study
排除标准
- •Patient who is, or is expected to be, inaccessible for follow-up
- •Patient is excluded by local local law
- •Patient is currently enrolled or plans to enroll in any concurrent drug and/or device study that may confound the Product Surveillence Registyr (PSR) results
结局指标
主要结局
Complication Survival Rate
时间窗: 5 years
Estimate OmniaSecure lead-related complication-free survival through 5 years post implant.
次要结局
未报告次要终点