Adapta Clinical Study to Evaluate the Overall System Safety and Clinical Performance of the Adapta Pacing System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 7
- 主要终点
- Freedom from adverse device effects
研究概览
简要总结
Pacemakers are implantable devices that pace (electrically stimulate) the heart. Some pacemakers have special programs to treat irregular atrial rhythms(top chambers of the heart beat too fast or too slow). Advances in pacemaker technology in recent years include features that automatically adapt to patient conditions without intervention from the clinician. Adapta (Model #ADDR01) is a new pacemaker that is designed to provide further automaticity advances by including the managed ventricular pacing (MVP) feature designed to promote intrinsic conduction (natural flow of electricity in the heart) by reducing unnecessary ventricular (lower chamber of the heart) pacing (electrical impulses). Adapta also contains a feature called TherapyGuide that is designed to allow the user to select certain conditions for each subject and receive a list of suggested pacemaker parameter value changes based on those conditions. The purpose of this study is to evaluate the overall system safety and clinical performance of the Adapta pacing system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have a Class I or II indication for implantation of a dual chamber pacemaker according to ACC/AHA/NASPE guidelines
- •Subjects who have signed a Medical Ethics Committee (MEC) approved Informed Consent Form
排除标准
- •Subjects with a mechanical tricuspid valve
- •Subjects with a life expectancy less than two years
- •Subjects with a Class III indication for permanent pacing
- •Subjects with lead integrity problems, unless leads are being replaced
结局指标
主要结局
Freedom from adverse device effects
次要结局
- To assess right ventricular (lower right chamber of the heart) pacing
- To summarize all adverse events reported in the study
- To describe Adapta system performance as observed during Holter recording, save-to disk-files and technical observations
- To evaluate the user acceptance of TherapyGuide via questionnaire data