A Multi-center Prospective Pilot Study to tEst LEft Ventricular Intra-cardiac Conduction Time as a Predictor of CRT Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- Correlation between LV-LV/RV-LV intra-cardiac conduction time and multiple hemodynamic parameters
研究概览
简要总结
Enrolled patients implanted with Biotronik CRT-D and QP lead equipped with MultiPole pacing mode is grouped into which programmed into MultiPole pacing, or conventional bi-ventricular pacing mode. They are followed up by seven month post implantation, and predefined cardiac functional parameters are collected at each visit.
详细描述
Enrolled patients will undergo the baseline medical tests to assess the cardiac functions (e.g. echo, blood test, and 12-Lead ECG) prior to the implantation of Biotronik CRT-D and QP lead featured with MultiPole Pacing parameter. At implantation, LV-LV conduction delays are measured in predefined LV pacing and sensing configurations. One month after the successful implantation, the patients revisit the investigation site to be adjudicated for programming MultiPole pacing or continuing bi-ventricular pacing mode, based on their echo readings by then. Patients are subsequently followed up at four and seven month post implantation to acquire the LV-LV conduction delays and echo readings, etc. at the time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible for the study enrollment, candidate patients must meet all of the following criteria
- •Indicated for a CRT-D implantation
- •Has never received CRT
- •Planned to be implanted with a quadripolar LV Lead, and CRT-D with MultiPole pacing feature, both manufactured by BIOTRONIK
- •Geographically stable and willing to comply with the required follow-up schedule
- •With written informed consent
排除标准
- •Candidate patients will not be eligible if either of the following criteria is applicable
- •Underwent a cardiac surgery within last 3 months, or scheduled for cardiac surgery other than CRT implantation
- •Life expectancy is less than a year
- •Can not be programmed to MultiPole pacing "ON"
- •Does not agree to the concept of HomeMonitoring System
- •With known pregnancy
- •At age below 20 years
- •Participated in another interventional clinical study
结局指标
主要结局
Correlation between LV-LV/RV-LV intra-cardiac conduction time and multiple hemodynamic parameters
时间窗: through study completion, an average of 7 months
LV-LV/RV-LV intra-cardiac conduction time will be obtained at each time frame, and correlation will be investigated with variation of multiple hemodynamic parameters from baseline up to seven month follow up.
次要结局
- Influence by baseline characteristics(through study completion, an average of 7 months)
- Rate of arrhythmia episodes(through study completion, an average of 7 months)