Evaluation of Left Ventricular Autothreshold, Phase Two
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Collect ventricular evoked response signals and CRT-D device data during LV only and Bi-ventricular (Bi-V) voltage step down pacing
研究概览
简要总结
This study will collect data, from an implanted Cardiac Resynchronization Therapy-Defibrillator (CRT-D) device, to further evaluate a new feature for future heart failure devices.
详细描述
ELEVATE 2.0 is an acute, prospective, multi-center, feasibility study randomized within patient test sequence and pulse width, designed to characterize the performance of the Left Ventricular Auto Threshold (LVAT) 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 have a COGNIS CRT-D device implanted for at least 24 hours, with or without a right atrial lead
- •Patients who have an active LV bipolar lead
- •Patients who have an active right ventricular (RV) defibrillation lead
- •Patients who are willing and capable of participating in all testing associated with this Clinical Investigation
- •Patients who are age 18 or above, or of legal age to give informed consent specific to state and national law
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
- •Patients who will not tolerate a pacing pause of up to 6 seconds
- •Patients who have a unipolar LV pace/sense lead, 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
- •Patients with a pre-existing unipolar pacemaker
- •Patients who are unable or unwilling to maintain a supine or sitting position for 40-50 minutes
- •Patients enrolled in any concurrent study, without Boston Scientific written approval
- •Women who are pregnant
结局指标
主要结局
Collect ventricular evoked response signals and CRT-D device data during LV only and Bi-ventricular (Bi-V) voltage step down pacing
时间窗: At least 24 hours post CRT-D implant
The primary objective of this study is to collect real-time signals during LV pacing voltage step-down from patients with implanted COGNIS CRT-D devices in a follow-up setting. This data will be used to assess the stability of the LV evoked response electrogram signal and will be used in an offline assessment of the LVAT algorithm. One or two data points will be collected per patient in the trial. Patients must be at least 24 hours post implant of their COGNIS CRT-D device
次要结局
未报告次要终点