Clinical Evaluation of Safety and Effectiveness of the BackBeat Medical Moderato System in Patients With Hypertension: A Double-Blind Randomized Trial - PV Loops Sub-study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in the LV pressures (mmHg)
研究概览
简要总结
The position of the RV lead may have an important role in the effectiveness of the Programmable Hypertension Control (PHC) therapy by the Moderato pacemaker eliciting a lag from which RV signals (QRS) are identified.
The study attempts to measure RV Pressure and RV Volume with PHC in two RV lead locations.
详细描述
Subjects found eligible for participation in the CS-03 study, who are indicated for a de novo pulse generator implant at the center participating in this sub-study and who are not 100% dependent on RV pacing are eligible for participation in this sub-study.
Patients receiving a pacemaker pulse generator exchange or who are 100% pacemaker dependent may not participate.
Eligible patients will be provided with an Informed Consent specific to this sub-study and if patients choose to participate, patients will be asked to sign the Informed Consent and will then undergo the procedures described below.
Patients will be prepared and draped for the Moderato implant procedure as detailed in the main CS-03 study protocol.
Subjects will be instrumented prior to the Moderato Pacemaker implant procedure.
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
- 否
入选标准
- •Subject was included in the CS-03 study
- •Subject indicated for a de novo pulse generator implant
排除标准
- •Subject was excluded from the CS-03 study
- •Subject is not 100% dependent on RV pacing
- •Subject receiving a pacemaker pulse generator exchange
- •Subject is unwilling or cannot provide Informed Consent for this sub study
研究组 & 干预措施
RV location
All included subjects will undergo the PV loop test with 'BackBeat PHC' ON and OFF
干预措施: BackBeat-PHC (Device)
结局指标
主要结局
Change in the LV pressures (mmHg)
时间窗: up to 2 hr
LV pressure will be assessed in two RV electrode lead locations with BackBeat PHC ON and OFF
Change in the LV volumes (ml)
时间窗: up to 2 hr
LV volume will be assessed in two RV electrode lead locations with BackBeat PHC ON and OFF
次要结局
- Change in the pressure-volume ratio(up to 2 hr)