NCT03049722已完成不适用
Clinical Investigation Plan for the AVOPT Data Collection
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Correlation analysis between measured PWD and optimal AVD.
研究概览
简要总结
The purpose of this study is to collect clinical data for the development and evaluation of a new device feature for automatic AV-delay (AVD) optimization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Patients implanted with an Evia DR(T) or Entovis DR(T) pacemaker
- •Possessing 1st or 3rd degree AV block
- •Implanted with Biotronik bipolar RA and RV leads
- •Implantation date should be at least 4 months prior to this study
排除标准
- •Patient is a minor (18 years old or younger)
- •Patient is pregnant or breast-feeding
- •Patient does not have the legal capacity to provide consent
- •Patient has Mobitz type I or Mobitz type II heart block
- •Patient has persistent supraventricular tachycardia (including atrial fibrillation) or ectopic beats.
- •Patient is participating in other clinical studies during the clinical study
- •Patient is strictly pacemaker dependent (physician discretion)
结局指标
主要结局
Correlation analysis between measured PWD and optimal AVD.
时间窗: Up to 6 hours
Data analysis will be performed on the collected data to relate P wave duration (PWD) measured from the far field IEGM to the optimal AVD determined from the hemodynamic assessment.
次要结局
未报告次要终点
研究者
研究点 (3)
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