NCT01539629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
- 50
- 试验地点
- 4
- 主要终点
- Collect ventricular evoked response signal and CRT-D device data during LV only and Bi-Ventricular voltage step-down pacing.
研究概览
简要总结
This 3rd phase of the ELEVATE study. The study is collecting data from an implanted CRT-D device to evaluate a new feature for future heart failure devices.
详细描述
ELEVATE 3.0 is an acute, prospective, multicenter feasibility study which is randomized within a patient test sequence and pulse width. The study is designed to characterize the performance of LVAT (Left Ventricular Authothreshold) 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 age 18 or above, or of legal age to give informed consent specific to state and national law
- •Patients who have a COGNIS CRT-D device implanted for at least 24 hours, with or without an active right atrial lead
- •Patients who have an active LV bipolar or unipolar lead
- •Patients who have an active RV defibrillation lead
- •Patients who are willing and capable of participating in all testing associated with this Clinical Investigation
排除标准
- •Patients who have a COGNIS CRT-D that has less than or equal to one year of battery life remaining
- •Patients who are pacemaker-dependent as defined as VVI 40 without intrinsic atrial or ventricular activity
- •Patients who will not tolerate a pacing pause of up to 6 seconds
- •Patients with a pre-existing unipolar pacemaker
- •Patients who are unable or unwilling to maintain a supine or sitting position for 20-50 minutes
- •Patients enrolled in any concurrent study, without Boston Scientific CRM written approval
- •Women who are pregnant;women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
结局指标
主要结局
Collect ventricular evoked response signal and CRT-D device data during LV only and Bi-Ventricular voltage step-down pacing.
时间窗: Minimum of 24 hrs post CRT-D implant.
The primary objective of this study is to collect real-time signals during LV pacing and voltage step-down from patients with implanted COGNIS devices.
次要结局
未报告次要终点
研究者
研究点 (4)
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