NCT02922036进行中（未招募）不适用
Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders, Previously Untreatable and High Risk Upgrade Patients (SOLVE CRT)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 127
- 主要终点
- Primary Efficacy 1
研究概览
简要总结
This study is a prospective, multi-center, pivotal trial to study the safety and efficacy of the WiSE-CRT System for Cardiac Re-synchronization Therapy.
详细描述
The WiSE-CRT System is an implantable cardiac pacing system capable of delivering pacing energy to the left ventricle of the heart without using a pacing lead.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
One part of the study was randomized. The final part of the study was single-arm, open label.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Primary Efficacy 1
时间窗: 6 Months
Mean relative % change in Left Ventricular End Systolic Volume (LVESV) baseline to 6 Months.
Primary Safety
时间窗: 6 Months
Freedom from Procedure and Device System related Type 1 Complications
次要结局
- Secondary Efficacy 2(6 Months)
- Secondary Efficacy 5(6 months)
- Secondary Efficacy 3(6 months)
- Secondary Efficacy 1(6 Months)
- Secondary Efficacy 4(6 months)
研究者
研究点 (127)
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