AVEIR Remote Care System Data Collection Non-Significant Risk Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Successful end-to-end transmission performance metrics
研究概览
简要总结
The goal of the study is to understand the performance of the AVEIR Remote Care System in an initial patient cohort which will inform the ability to offer a remote follow-up solution to all patients implanted with Aveir LP devices.
详细描述
To collect acute performance data about the AVEIR Remote Care System in participants implanted with a compatible dual or single chamber Aveir Leadless Pacemaker System by participants completing remote transmissions with the system
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- 是
入选标准
- •Subject must provide written informed consent prior to any study-related procedure.
- •Subject is willing and has consented to study clinical procedure.
- •Subject is ≥ 18 years of age or age of legal consent, whichever age is greater
- •Subject has an active, appropriately functioning Aveir leadless pacemaker system
- •Subject is willing to use the device
排除标准
- •Subject is unable to read/write at a sufficient level to provide informed consent.
- •Subject is unable to make the decision to participate in a clinical investigation on their own or are unable to fully understand all aspects of the investigation that are relevant to the decision to participate.
- •Subject has presence of medical, social, or psychological conditions that, in the investigator's opinion, could confound the study, limit the subject's ability to participate in the clinical investigation .
结局指标
主要结局
Successful end-to-end transmission performance metrics
时间窗: The expected duration of each subject's participation is approximately 30 minutes for an in-clinic visit to complete two transmissions and thereafter an optional at-home transmission (expected duration 10-15 minutes)
Successful transmission performance metrics of the AVEIR Remote Care System in approximately 32 subjects who have received an Aveir LP implanted system as part of their standard of care.
次要结局
未报告次要终点