Comparison of in Office Interrogation vs. Remote Measurements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 6
- 主要终点
- Efficacy of the automated data collection as compared to manual testing results for atrial and ventricular pacing thresholds
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of the automated data collection in the Zephyr device as compared to manual testing results for atrial and ventricular pacing thresholds. The secondary objectives include: to compare the in-clinic time needed to retrieve and document the automated device measurements for all tests to the additional time needed to manually measure sensing, impedance and thresholds for the same patient; to compare the accuracy of the automated device test results to manual testing results; evaluate the percentage of patients who are recommended for ACapTM Confirm utilization.
The Primary Hypotheses are:
- The values reported from ACapTM Confirm will be within 0.125 V of the value that is obtained manually in clinic.
- The values reported from VentricularAutoCaptureTM will be within 0.125 V of the value that is obtained manually in clinic.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
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
- •Patients have been implanted with their device ~ 6 months prior
- •Patients must have their device evaluated at the enrolling center.
- •Patients must be able to comply with the regular routine follow-up schedule of the enrolling clinic.
- •Patients must be able and willing to provide written informed consent to participate in the clinical trial.
- •Patients age 18 or greater.
排除标准
- •Patient has a unipolar atrial lead implanted.
- •Patients who are or may potentially be pregnant.
- •Patients with persistent AF.
- •Less than 1 year life expectancy
结局指标
主要结局
Efficacy of the automated data collection as compared to manual testing results for atrial and ventricular pacing thresholds
时间窗: 12 and 18 months post-implant
次要结局
- To compare the in-clinic time needed to retrieve and document the automated device measurements for all tests to the additional time needed to manually measure sensing, impedance and thresholds for the same patient.(12 and 18 months post-implant)