Clinical Study to Evaluate System Safety and Clinical Performance of the AdvisaTM IPG
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- USADE at 1 month post implant
研究概览
简要总结
The purpose of the Advisa IPG clinical study is to evaluate the overall system safety and clinical performance of the Advisa DR Implantable Pulse Generator (IPG).
详细描述
The Advisa IPG is an investigational dual chamber pacemaker that provides rate-responsive bradycardia pacing and diagnostics and atrial tachycardia detection and therapy.
The study will be a prospective, non-randomized, multicenter clinical study, conducted.
To allow for sufficient experience with the device, a maximum of 80 subjects may be implanted with the Advisa device. Data will be collected at baseline (enrollment), implant, 1-, 3- and 6- months post implant and every 6 months thereafter or until study closure (whichever occurs first), unscheduled follow-up visits, System Modifications, Technical Observations, Study Deviations, Study Exit, upon notification of new or updated Adverse Events and in case of death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have an IPG indication for implantation of a dual chamber pacemaker.
- •Patients who are geographically stable and available for follow-up at the study center for the duration of the study.
- •Patients who have signed a Medical Ethics Committee (MEC) approved Informed Consent form.
排除标准
- •Patients with a life expectancy less than the duration of the study.
- •Patients with a Class III indication for permanent pacing according to ACC/AHA/NASPE 2002 guidelines.
- •Patients with medical conditions that preclude the testing required for all patients by the study protocol or that otherwise limit study participation required for all patients.
研究组 & 干预措施
Implant Advisa IPG
Advisa IPG implant
干预措施: Advisa IPG (Device)
结局指标
主要结局
USADE at 1 month post implant
时间窗: 1 month
Confirm safety of the device by assessing the percentage of subjects with an unanticipated serious adverse device effect (USADE) at 1-month post-implant
次要结局
- Advisa IPG system performance(1 month)