Left Ventricular Capture Management (LVCM) Software Download Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 18
- 主要终点
- To evaluate the accuracy of left ventricular capture management (LVCM)
研究概览
简要总结
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed.
Left Ventricular Capture Management (LVCM) refers to the overall method for determining left ventricular thresholds (level of energy needed to effectively pace the tissue in the lower left chamber of the heart) by measuring, analyzing, and adjusting energy delivered from the CRT device to the pacing lead.
The purpose of the Left Ventricular Capture Management Software Download Clinical Trial was to evaluate the accuracy of the Left Ventricular Capture Management (LVCM) feature to support LVCM feature approval in future cardiac resynchronization therapy with defibrillation (CRT-D) devices
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Subjects who successfully underwent implantation of an InSync II Marquis system
排除标准
- •Subjects who are post-heart transplant
- •Subjects enrolled in a concurrent study that may confound the results of this study
结局指标
主要结局
To evaluate the accuracy of left ventricular capture management (LVCM)
次要结局
- To compare left ventricular capture management (LVCM) measurements to a similar measurement taken automatically when subjects are completing normal daily activities
- To evaluate subject rhythm and rate immediately following an LVCM measurements
- To characterize all adverse events