BIO|CONCEPT.Amvia, First in Human Study for the Amvia/Solvia Pacemaker Family
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 14
- 主要终点
- Serious Adverse Device Effect (SADE)-Free Rate After 12 Months
研究概览
简要总结
The goal of this exploratory study is to test the preliminary safety and product performance of the new Amvia/Solvia pacemaker family in subjects that require a pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation. The study will be conducted at sites in Australia and New Zealand. It is planned to include 50 subjects in the study. Participants will visit sites at enrollment in the study, at implantation, pre-hospital discharge, 1- 3- and 12-month follow-up visits. At the visits the device will be interrogated and standard device measurements including those related to special features will be performed to assess the functionality of the device. Programming of the pacemakers will be done according to the participant´s therapeutical needs.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Standard indication for pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation, including de novo, upgrade or replacement implantations
- •Ability to understand the nature of the study
- •Willingness to provide written informed consent
- •Ability and willingness to perform all follow-up visits at the study site
- •Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring concept
排除标准
- •Planned for conduction system pacing
- •Planned for activation of atrial anti-tachycardia pacing (aATP) without known history of atrial arrhythmia, or with permanent atrial fibrillation (AF)
- •Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months
- •Pregnant or breast feeding
- •Age less than 18 years
- •Participation in another interventional clinical investigation according to the definition given in the study protocol
- •Life-expectancy less than 12 months
结局指标
主要结局
Serious Adverse Device Effect (SADE)-Free Rate After 12 Months
时间窗: 12 months
Descriptive statistics of the investigational device related SADE-free rate after first implantation attempt will be calculated using a Kaplan-Meier estimate
次要结局
未报告次要终点