NCT00812201已完成不适用
Evaluation of Left Ventricular AutoThreshold
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The objective of this study is to collect data to characterize the performance of the LVAT feature.
研究概览
简要总结
This study will collect data on a new feature for future heart failure devices via an external non-implantable system.
详细描述
ELEVATE is an acute, prospective, multi-center, feasibility study with a randomized within patient test sequence and pulse width, designed to characterize the performance of the Left Ventricular Auto Threshold feature.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 who are scheduled to receive a CRT-P or CRT-D, based on physician discretion
- •Patients who are willing and capable of participating in all testing associated with this study
- •Patients who are 18 or above, or of legal age to give informed consent specific to state and national law
排除标准
- •Patients who have, or are scheduled to receive a unipolar LV pace/sense lead to be used with the CRT-P/CRT-D device, unless the patient has any commercially available epicardial leads with at least two electrodes (from one or more leads)
- •Patients with pre-existing leads other than those specified in this investigational plan (unless the Investigator intends to replace them with permitted leads)
- •Patients with a pre-existing unipolar pacemaker that will not be explanted/abandoned
- •Patients enrolled in any concurrent study, without Boston Scientific CRM written approval, that may confound the results of this study
- •Patients with a prosthetic mechanical tricuspid heart valve
- •Women who are pregnant
结局指标
主要结局
The objective of this study is to collect data to characterize the performance of the LVAT feature.
时间窗: Implant
次要结局
未报告次要终点
研究者
研究点 (2)
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