ConductIoN System pacInG witH IngeviTy+ for the Left Bundle Branch Area
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,383
- 试验地点
- 8
- 主要终点
- Lead-Related Complication Free Rate
研究概览
简要总结
The study is intended to evaluate the safety and effectiveness of the Boston Scientific INGEVITY+ cardiac pacing lead when implanted in the left bundle branch area (LBBA).
详细描述
INSIGHT is a prospectively defined analysis of INGEVITY+ leads that have been previously implanted in the LBBA for the purpose of anti-bradycardia pacing. The results will provide complication free rate (safety) and lead measurements (performance).
Data will be gathered by means of a retrospective, multi-center, US only observational chart review to obtain data on INGEVITY+ leads implanted in the LBBA. Additional data will be gathered from the pulse generator and from the LATITUDE remote monitoring system for pacing thresholds and R-wave amplitude. Consecutive implants will be collected from each site for evaluating the endpoints.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Day 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Lead-Related Complication Free Rate
时间窗: Implant through 90 days
Adverse events that require correction with an invasive intervention or resulted in significant loss of device functionality.
Sensed R-wave amplitude
时间窗: Implant through 90 days
Percent of INGEVITY+ leads with an R-wave amplitude greater than 5mV.
Pacing Threshold
时间窗: Implant through 90 days
Percent of INGEVITY+ leads with pacing capture threshold measurement of less than or equal to 2V.
次要结局
未报告次要终点